A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies
- Sponsor
- Kumquat Biosciences Inc.
- Study ID
- NCT07542704
- Phase
- PHASE1
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Advanced Solid Tumors
- Colorectal Cancer (CRC)
- KRAS G12C Mutations
- KRAS G12S Mutations
- Non-Small Cell Lung Cancer
- Uterine Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- KQB368 — DRUGOral KQB368
Study Details
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
Key Dates
- Start date
- May 31, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Monotherapy Dose Escalation
Primary Outcome Measure
Primary Objective [ Time Frame: Up to 44 months ]
Central Contacts
- Kumquat Clinical Development Telephone858.214.2700
Related Studies
- Harvesting Cells for Experimental Cancer TreatmentsEnrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland
- Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL ActivityPHASE2 · Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
- Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial TumorsRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung CancerPHASE3 · Recruiting · University of Texas Southwestern Medical Center · La Jolla, California