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Clinical Trials/NCT07542704
NCT07542704
Not yet recruiting
Phase 1

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

Kumquat Biosciences Inc.0 sites48 target enrollmentStarted: May 1, 2026Last updated:
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ConditionsAdvanced Solid TumorsColorectal Cancer (CRC)Non-Small Cell Lung CancerUterine CancerKRAS G12C MutationsKRAS G12S Mutations
InterventionsKQB368
DrugsKQB368

Overview

Phase
Phase 1
Status
Not yet recruiting
Enrollment
48
Primary Endpoint
Primary Objective
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Histologically confirmed diagnosis of a solid tumor
  • •Malignancy with either a KRAS G12C or KRAS G12S mutation
  • •Unresectable or metastatic disease
  • •No available treatment with curative intent
  • •Adequate organ function
  • •Measurable disease per RECIST v1.1
  • •Must be able to swallow with no GI condition that prevents absorption

Exclusion Criteria

  • Not provided

Arms & Interventions

Monotherapy Dose Escalation

Experimental

Intervention: KQB368 (Drug)

Outcomes

Primary Outcomes

Primary Objective

Time Frame: Up to 44 months

Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 30 days after last dose of study treatment.

Secondary Outcomes

  • Objective response rate (ORR)(Up to 44 months)
  • Overall survival (OS)(Up to 44 months)
  • Duration of response (DOR)(Up to 44 months)
  • Time to response (TTR)(Up to 44 months)
  • Disease control rate (DCR)(Up to 44 months)
  • Progression-free survival (PFS)(Up to 44 months)
  • Area under the concentration-time curve (AUC)(Up to 44 months)
  • Maximum plasma concentration (Cmax)(Up to 44 months)
  • Time to maximum plasma concentration (tmax)(Up to 44 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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