Trial Outcomes & Findings for A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery (NCT NCT05446129)

Last Updated: 2025-03-13

Results Overview

Safety: A safety event was defined as any grade 3 or higher adverse events (AEs; according to National Cancer Institute's Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) related to study treatments at any point within the follow-up period following the administration of study treatments. Feasibility (delay in surgery): A feasibility event or delay in surgery was defined as any treatment related AE leading to delay in surgery, which was scheduled to take place between 2 weeks and up to 6 weeks following the study treatment administration will be considered as a relevant AE for this endpoint.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

2 participants

Primary outcome timeframe

Up to 91 days after drug administration.

Results posted on

2025-03-13

Participant Flow

An open-label, single-center, two-arm, parallel-group Phase I trial to assess the safety and feasibility of a single dose of BI 765063 in combination with either ezabenlimab (Cohort A) or pembrolizumab (Cohort B) in participants with early-stage, resectable colorectal cancer in a neoadjuvant setting.

Only two participants were enrolled in this trial. All participants were screened for eligibility prior to participation and attended a specialist site to ensure strict adherence to all inclusion criteria and none of the exclusion criteria. Participants were not allocated to a treatment group if any entry criteria were violated. The trial was prematurely discontinued due to the low number of enrolled participants.

Participant milestones

Participant milestones
Measure	Cohort A: Ezabenlimab + BI 765063 Participants received two separate consecutive intravenous (i.v.) infusions on Day 1. First, they received one flat dose of 240 milligram (mg) ezabenlimab and then one dose of BI 765063.	Cohort B: Pembrolizumab + BI 765063 Participants received two separate consecutive intravenous (i.v.) infusions on Day 1. First, they received one flat dose of 200 milligram (mg) Pembrolizumab and then one dose of BI 765063.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Ezabenlimab + BI 765063 n=1 Participants Participants received two separate consecutive intravenous (i.v.) infusions on Day 1. First, they received one flat dose of 240 milligram (mg) ezabenlimab and then one dose of BI 765063.	Cohort B: Pembrolizumab + BI 765063 n=1 Participants Participants received two separate consecutive intravenous (i.v.) infusions on Day 1. First, they received one flat dose of 200 milligram (mg) Pembrolizumab and then one dose of BI 765063.	Total n=2 Participants Total of all reporting groups
Age, Customized >= 18 years	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: Up to 91 days after drug administration.

Population: The trial was discontinued early due to slow participant enrollment. Only a patient profile listing containing data collected for individual participants was compiled and statistical outputs and analyses i.e. the primary and secondary outcome measurements were not assessed.

Outcome measures

Outcome measures
Measure	Ezabenlimab + BI 765063 n=1 Participants Participants assigned to this Cohort received a flat dose of 240 mg ezabenlimab in combination with a dose of BI 765063.	Pembrolizumab + BI 765063 n=1 Participants Participants assigned to this Cohort received a flat dose of 200 mg pembrolizumab in combination with a dose of BI 765063.
Composite Endpoint: Proportion of Patients With at Least One Occurrence of a Safety or Feasibility Event	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 91 days after drug administration.

Population: The trial was discontinued early due to slow participant enrollment.

At least 50% or more tumor regression classified as per Mandard tumor regression grading system, in viable adenocarcinoma cells in the surgical specimen, including lymph nodes. Pathological response includes complete pathology response (CR), near complete pathological response (near CR) and partial pathological response

Outcome measures

Outcome measures
Measure	Ezabenlimab + BI 765063 n=1 Participants Participants assigned to this Cohort received a flat dose of 240 mg ezabenlimab in combination with a dose of BI 765063.	Pembrolizumab + BI 765063 n=1 Participants Participants assigned to this Cohort received a flat dose of 200 mg pembrolizumab in combination with a dose of BI 765063.
Pathologic Response (PR) Complete pathology response (CR)	0 Percentage of Participants	0 Percentage of Participants
Pathologic Response (PR) Near complete pathological response (near CR)	0 Percentage of Participants	0 Percentage of Participants
Pathologic Response (PR) Partial pathological response	0 Percentage of Participants	0 Percentage of Participants
Pathologic Response (PR) No response	1 Percentage of Participants Not calculable with one subject	1 Percentage of Participants Not calculable with one subject

SECONDARY outcome

Timeframe: Up to 91 days after drug administration.

Population: The trial was discontinued early due to slow participant enrollment.

Time from administration of trial treatment to surgery, defined as the time in days that elapses between administration of neoadjuvant trial therapy and surgical resection.

Outcome measures

Outcome measures
Measure	Ezabenlimab + BI 765063 n=1 Participants Participants assigned to this Cohort received a flat dose of 240 mg ezabenlimab in combination with a dose of BI 765063.	Pembrolizumab + BI 765063 n=1 Participants Participants assigned to this Cohort received a flat dose of 200 mg pembrolizumab in combination with a dose of BI 765063.
Time From Administration of Trial Treatment to Surgery	19 days Standard Deviation NA The standard deviation for this endpoint could not be calculated.	19 days Standard Deviation NA The standard deviation for this endpoint could not be calculated.

SECONDARY outcome

Timeframe: Up to 91 days after drug administration.

Population: The trial was discontinued early due to slow participant enrollment.

Radiographic response on pre-surgical imaging, following receipt of the neoadjuvant therapy, as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). The same imaging procedure(s) (computed tomography, magnetic resonance imaging scan) were used throughout the trial.

Outcome measures

Outcome measures
Measure	Ezabenlimab + BI 765063 n=1 Participants Participants assigned to this Cohort received a flat dose of 240 mg ezabenlimab in combination with a dose of BI 765063.	Pembrolizumab + BI 765063 n=1 Participants Participants assigned to this Cohort received a flat dose of 200 mg pembrolizumab in combination with a dose of BI 765063.
Radiographic Response Rate Complete Response (CR)	0 Percentage of participants	0 Percentage of participants
Radiographic Response Rate Stable Disease (SD)	100 Percentage of participants Not calculable with one subject	100 Percentage of participants Not calculable with one subject
Radiographic Response Rate Partial Response (PR)	0 Percentage of participants	0 Percentage of participants
Radiographic Response Rate Progressive Disease (PD)	0 Percentage of participants	0 Percentage of participants

Adverse Events

Ezabenlimab + BI 765063

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Pembrolizumab + BI 765063

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ezabenlimab + BI 765063 n=1 participants at risk Participants assigned to this Cohort received a flat dose of 240 mg ezabenlimab in combination with a dose of BI 765063.	Pembrolizumab + BI 765063 n=1 participants at risk Participants assigned to this Cohort received a flat dose of 200 mg pembrolizumab in combination with a dose of BI 765063.
Blood and lymphatic system disorders Anaemia	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
Gastrointestinal disorders Diarrhoea	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
General disorders Influenza like illness	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
General disorders Pain	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
Investigations White blood cell count decreased	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
Metabolism and nutrition disorders Hyperglycaemia	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
Metabolism and nutrition disorders Hypoalbuminaemia	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
Metabolism and nutrition disorders Hypocalcaemia	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
Metabolism and nutrition disorders Hyponatraemia	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
Nervous system disorders Dizziness	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.
Gastrointestinal disorders Constipation	100.0% 1/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.	0.00% 0/1 • Up to 91 days after drug administration. All participants that had been screened and treated, and had completed the trial before the trial was discontinued.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 018002430127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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