NCT07542704

A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies

StatusRecruiting

PhasePhase 1

SponsorKumquat Biosciences Inc.

Primary completionDec 2029 (estimated)

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

Notable Oct 30, 2026 Recruitment opened Show 4 more changesShow less
- Trial sites expanded: 0 → 14 locations
- Start date changed from estimate of May 2026 to May 27, 2026
- Eligibility criteria expanded, about 7 words
- Secondary endpoints: details revised at 2 of 9 entries
Apr 17, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Primary Objective

Timeframe: Up to 44 months

Secondary (9)

Objective response rate (ORR)

Overall survival (OS)

Duration of response (DOR)

Time to response (TTR)

Disease control rate (DCR)

Show 4 moreShow less

Progression-free survival (PFS)

Area under the concentration-time curve (AUC)

Maximum plasma concentration (Cmax)

Time to maximum plasma concentration (tmax)

Arms and interventions

Monotherapy Dose EscalationExperimental

Drugs: KQB368

Sites

14 sites in 1 country

About this trial

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

Trial details

Enrollment: 48 participants (estimated)
Started: May 27, 2026
Study completion: Dec 2029 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, open label, treatment
Oversight: No data monitoring committee, FDA-regulated drug
Conditions: Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Uterine Neoplasms, Advanced Solid Tumors, Colorectal Cancer (CRC), Non-Small Cell Lung Cancer, Uterine Cancer, KRAS G12C Mutations +1 more
Collaborators: Worldwide Clinical Trials
Official title: A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
First posted: Apr 21, 2026
Registry updated: Nov 3, 2026
Last verified: Oct 2026

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