Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT07207707
NCT07207707RecruitingPhase 1

A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation

Kumquat Biosciences Inc.18 sites in 1 country78 target enrollmentStarted: September 16, 2025Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Interventions

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
78
Locations
18
Primary Endpoint
Safety,Tolerability, MTD/MAD and/or RDE in the Study Population
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are:

  • What is the safe dose of KQB548?
  • Does KQB548 decrease the size of the tumor?
  • What happens to KQB548 in the body?

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

  • •Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation
  • •Progressed on, or intolerant to at least one prior line of systemic standard of care therapy
  • •Measurable disease according to RECIST v1.1
  • •Adequate organ function

Exclusion Criteria

  • •Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor
  • •History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications
  • •Poorly controlled ascites and/or pleural effusion
  • •Requires treatment with a strong and/or moderate CYP3A inhibitor or inducer
  • •Requires treatment with a proton-pump inhibitor

Arms & Interventions

Monotherapy Dose Escalation

Experimental

Intervention: KQB548 (Drug)

Outcomes

Primary Outcomes

Safety,Tolerability, MTD/MAD and/or RDE in the Study Population

Time Frame: Up to 30 months

Safety characterized by type, incidence and severity of treatment emergent adverse events (TEAEs), SAEs, and DLTs

Secondary Outcomes

  • Evaluate Changes in QTc (mSec)(Up to 30 months)
  • Plasma Concentration-time curve (AUC)(Up to 30 months)
  • Maximum plasma concentration (Cmax)(Up to 30 months)
  • Time to maximum plasma concentration (tmax)(Up to 30 months)
  • Overall Response Rate (ORR)(Up to 30 months)
  • Duration of Response (DOR)(Up to 30 months)
  • Time to Response (TTR)(Up to 30 months)
  • Disease Control Rate (DCR)(Up to 30 months)
  • Progression Free Survival (PFS)(Up to 30 months)
  • Overall Survival (OS)(Up to 30 months)
  • Peak Plasma Concentration (Cmax) in Fed and Fasted States for Food Effect(Up to 30 months)
  • Concentration Time Curve (AUC) in Fed and Fasted States for Food Effect(Up to 30 months)
  • Time to maximum plasma concentration (tmax) in Fed and Fasted States for Food Effect(Up to 30 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (18)

Loading locations...

Similar Trials

Active, not recruiting
Phase 1
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid MalignanciesSolid Tumor, Adult
NCT06507306Kumquat Biosciences Inc.92
Recruiting
Phase 1
A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
NCT06994806Kumquat Biosciences Inc.84
Recruiting
Phase 1
A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
NCT06720987Kumquat Biosciences Inc.140
Recruiting
Phase 1
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic MalignanciesHematologic MalignanciesAdult
NCT06645886Kumquat Biosciences Inc.122
Recruiting
Phase 1
A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
NCT06803680BeOne Medicines90