Trial Outcomes & Findings for A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors (NCT NCT05949632)

Last Updated: 2026-06-04

Results Overview

Any adverse event that ws at least possibly related to study treatment and met protocol-specified criteria was classified as a DLT. For the purpose of dose finding, decisions on dose were based on DLTs observed during the first 21 days of treatment.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

up to 3 weeks

Results posted on

2026-06-04

Participant Flow

This study was conducted at 3 study centers in the United Kingdom.

Participant milestones

Participant milestones
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID n=5 Participants Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Age, Continuous	54.6 years STANDARD_DEVIATION 10.74 • n=9 Participants
Sex: Female, Male Female	5 Participants n=9 Participants
Sex: Female, Male Male	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	1 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants
Race (NIH/OMB) White	4 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants

PRIMARY outcome

Timeframe: up to 3 weeks

Population: DLT-Evaluable Population: all participants in Part 1 who had a DLT during the 3-week DLT observation period or received at least 75% of the planned doses of both INCB099280 and axitinib at the assigned dose.

Outcome measures

Outcome measures
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID n=5 Participants Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)	1 Participants

PRIMARY outcome

Timeframe: up to approximately 1 year

Population: Safety Population: all participants who received at least 1 dose of INCB099280 or axitinib. Analysis in the Safety Population was based on the actual dose received regardless of assigned dose.

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.

Outcome measures

Outcome measures
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID n=5 Participants Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	5 Participants

PRIMARY outcome

Timeframe: up to approximately 1 year

Population: Safety Population

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.

Outcome measures

Outcome measures
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID n=5 Participants Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug) TEAE leading to dose interruption of INCB099280	5 Participants
Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug) TEAE leading to discontinuation of INCB099280	0 Participants
Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug) TEAE leading to dose interruption of axitinib	4 Participants
Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug) TEAE leading to dose reduction of axitinib	3 Participants
Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug) TEAE leading to discontinuation of axitinib	1 Participants

PRIMARY outcome

Timeframe: up to 2 years

Population: Full Analysis Set: all participants who received at least 1 dose of INCB099280 or axitinib. Analysis in the FAS was based on assigned dose. Enrollment in this study was closed during Part 1 following the sponsor's decision to discontinue the INCB099280 development program for strategic reasons. There were no safety concerns that contributed to the decision. Part 2 of the study was not conducted.

Objective response was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years

Population: Safety Population. Enrollment in this study was closed during Part 1 following the sponsor's decision to discontinue the INCB099280 development program for strategic reasons. There were no safety concerns that contributed to the decision. Part 2 of the study was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 335 days

Population: Full Analysis Set. Confidence intervals were calculated using the Clopper-Pearson method.

Objective response was defined as the percentage of participants with a BOR of CR or PR by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Outcome measures

Outcome measures
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID n=5 Participants Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Part 1: Objective Response	20.0 percentage of participants Interval 0.5 to 71.6

SECONDARY outcome

Timeframe: up to 335 days

Population: Full Analysis Set. Confidence intervals were calculated using the Clopper-Pearson method. In order to have a best overall response of SD, overall response must have met the SD criteria at least once after a minimum of 5 weeks from the start of treatment.

Disease control was defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD) by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Outcome measures

Outcome measures
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID n=5 Participants Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Part 1: Disease Control	80.0 percentage of participants Interval 28.4 to 99.5

SECONDARY outcome

Timeframe: up to 335 days

Population: Full Analysis Set. Only participants with a CR or PR were analyzed.

DOR was defined as the time from the first CR or PR until disease progression by investigator assessment per RECIST v1.1 or death from any cause, whichever occurred earlier. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

Outcome measures

Outcome measures
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID n=1 Participants Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Part 1: Duration of Response (DOR)	8.0 months The confidence interval cannot be calculated for a single participant.

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

Population: Pharmacokinetic (PK)-Evaluable Population: all participants who received at least 1 dose of either INB099280 or axitinib and provided at least 1 postbaseline sample for PK analysis. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future.

Blood samples were collected for the analysis of INCB099280 and axitinib concentrations. Per Protocol, PK samples for axitinib were only to be analyzed in case of a concern that axitinib was not as active as expected. Due to the early termination of the study before readout, these samples were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future.

Cmax was defined as the maximum observed concentration of INCB099280.

Outcome measures

Outcome data not reported

SECONDARY outcome

tmax was defined as the time to the maximum concentration of INCB099280.

Outcome measures

Outcome data not reported

SECONDARY outcome

AUC0-4h was defined as area under the steady-state plasma or serum concentration-time curve from 0 to 4 hours.

Outcome measures

Outcome data not reported

SECONDARY outcome

Cmax,ss was defined as the maximum observed concentration at steady state.

Outcome measures

Outcome data not reported

SECONDARY outcome

tmax,ss was defined as the time to the maximum concentration of INCB099280 at steady state.

Outcome measures

Outcome data not reported

SECONDARY outcome

AUC0-12h was defined as the area under the steady-state plasma or serum concentration-time curve from 0 to 12 hours.

Outcome measures

Outcome data not reported

SECONDARY outcome

Cavg was defined as the average concentration of INCB099280.

Outcome measures

Outcome data not reported

SECONDARY outcome

Ctau was defined as the concentration of INCB099280 at the end of a dose interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

t1/2 was defined as the apparent terminal-phase disposition half life of INCB099280.

Outcome measures

Outcome data not reported

SECONDARY outcome

CLss/F was defined as the apparent oral dose clearance of INCB099280 at steady state.

Outcome measures

Outcome data not reported

SECONDARY outcome

Vz/F was defined as the apparent oral dose volume of distribution of INCB099280.

Outcome measures

Outcome data not reported

Adverse Events

INCB099280 400 mg BID Plus Axitinib 5 mg BID

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID n=5 participants at risk Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Eye disorders Vision blurred	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.

Other adverse events

Other adverse events
Measure	INCB099280 400 mg BID Plus Axitinib 5 mg BID n=5 participants at risk Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
Infections and infestations Catheter site infection	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Infections and infestations Otitis media	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Injury, poisoning and procedural complications Contusion	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Investigations Alanine aminotransferase increased	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Investigations Aspartate aminotransferase increased	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Investigations Blood alkaline phosphatase increased	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Investigations Weight decreased	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Musculoskeletal and connective tissue disorders Arthralgia	40.0% 2/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Musculoskeletal and connective tissue disorders Arthritis	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Musculoskeletal and connective tissue disorders Osteoarthritis	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Nervous system disorders Dysgeusia	40.0% 2/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Nervous system disorders Headache	40.0% 2/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Nervous system disorders Posterior reversible encephalopathy syndrome	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Psychiatric disorders Anxiety	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Respiratory, thoracic and mediastinal disorders Epistaxis	40.0% 2/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	40.0% 2/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Skin and subcutaneous tissue disorders Rash	40.0% 2/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Skin and subcutaneous tissue disorders Dry skin	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Skin and subcutaneous tissue disorders Erythema	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Skin and subcutaneous tissue disorders Miliaria	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Skin and subcutaneous tissue disorders Skin plaque	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Vascular disorders Hypertension	80.0% 4/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Ear and labyrinth disorders Hypoacusis	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Gastrointestinal disorders Diarrhoea	60.0% 3/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Gastrointestinal disorders Nausea	40.0% 2/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Gastrointestinal disorders Stomatitis	40.0% 2/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Gastrointestinal disorders Constipation	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Gastrointestinal disorders Dry mouth	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Gastrointestinal disorders Gastrointestinal pain	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Gastrointestinal disorders Gastrooesophageal reflux disease	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
General disorders Asthenia	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
General disorders Chest pain	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
Hepatobiliary disorders Hypertransaminasaemia	20.0% 1/5 • up to approximately 1 year Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Publication restrictions are in place

Restriction type: OTHER