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KQB365 for Advanced Solid Tumors with KRAS G12C or G12S Mutation

This study is testing a drug called KQB365, alone or with other drugs (cetuximab or KQB198), for adults with advanced solid tumors that have specific genetic changes (KRAS G12C or KRAS G12S mutations). This includes certain colorectal cancers. Researchers want to find out the safest dose of KQB365 and if it can shrink tumors. They will also study how KQB365 moves through the body. You would receive KQB365 through an IV (intravenous infusion) weekly, sometimes with oral KQB198 or IV cetuximab. The study aims to enroll about 140 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is designed to evaluate both safety and effectiveness, and involves about 140 participants.
What's involved
You would visit the clinic about 9 times in the first 6 weeks, and then once every week after that. You would receive KQB365 infusion weekly, potentially with other medications.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes like side effects from enrollment to the end of treatment, and tumor response for up to 35 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06720987

A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kumquat Biosciences Inc.
~140 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:KQB365CetuximabKQB198

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
Measured over From enrollment to the end of treatment
+2 more outcomes measured

Conditions

KRAS G12C Mutation
KRAS G12S Mutation
Solid Tumor Malignancies
CRC (Colorectal Cancer)

Explore related trials

Colorectal CarcinomaSolid NeoplasmGTPase KRas

Where it's being run

11 sites across 11 states
Arizona1
Colorado1
Florida1
Massachusetts1
Michigan1
Minnesota1
Ohio1
Oklahoma1

Who to contact

Kumquat Clinical Development
[email protected]
(858) 214-2700
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum 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

Exclusion

Active primary central nervous system tumors
Cardiac abnormalities
Active interstitial lung disease
Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts

What this trial measures

  • Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)From enrollment to the end of treatment

    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.

  • Recommended Phase 2 Dose (RP2D) (Part 1)up to 35 months

    Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.

  • Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2)up to 35 months

    ORR is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.