A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies
NCT07542704 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-04-21
Summary
The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are:
* What is the safe dose of KQB368 as a monotherapy?
* Does KQB368 decrease the size of the tumor?
* What happens to KQB368 in the body?
Participants will:
* Take KQB368 orally daily in 21-day cycles
* Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that
Conditions
- Advanced Solid Tumors
- Colorectal Cancer (CRC)
- Non-Small Cell Lung Cancer
- Uterine Cancer
- KRAS G12C Mutations
- KRAS G12S Mutations
Interventions
- DRUG
-
KQB368
Oral KQB368
Sponsors & Collaborators
-
Worldwide Clinical Trials
collaborator OTHER -
Kumquat Biosciences Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2029-12-31
- Completion
- 2029-12-31
- FDA Drug
- Yes
More Related Trials
-
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
NCT04430842 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors
NCT05462873 ·Status: TERMINATED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors
NCT05461287 ·Status: UNKNOWN ·Phase: PHASE1
-
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
NCT06949761 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
NCT05410145 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT03071757 ·Status: COMPLETED ·Phase: PHASE1
-
QTX3046 in Patients With KRAS G12D Mutations
NCT06428500 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
SKB105 for Injection in Advanced Solid Tumors
NCT07380386 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
NCT05067283 ·Status: RECRUITING ·Phase: PHASE1
-
JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
NCT06973564 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
QLS5212 for Participants With Advanced Solid Tumors
NCT07467629 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of QLS5133 Monotherapy in Advanced Solid Tumors
NCT07061639 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
SKB103 for Injection in Advanced Solid Tumors
NCT07459998 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Clinical Trial of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors
NCT05645315 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors Including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC)
NCT04718675 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A First-in-human Study of KY-0301 in Patients With Advanced Solid Tumors.
NCT06928363 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
A Clinical Study of TQB3823 in Patients With Advanced Malignant Tumor
NCT05021367 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
QTX3034 in Patients With KRAS G12D Mutation
NCT06227377 ·Status: RECRUITING ·Phase: PHASE1
-
A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.
NCT07456046 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of QLS1209 in theTreatment of Patients With Advanced Solid Tumors
NCT06872580 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
NCT05002270 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
NCT06959615 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3804 in Subjects With Advanced Malignant Tumors
NCT04128085 ·Status: UNKNOWN ·Phase: PHASE1
-
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
NCT05394103 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
First in Human Study of QLS5316 in Solid Tumors
NCT07358884 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1