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

NCT06720987 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-04-23

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are:

* What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198?
* Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor?
* What happens to KQB365 in the body?

Participants will:

* Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198.
* Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

Conditions

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

Interventions

DRUG

KQB365

Intravenous KQB365

DRUG

Cetuximab

Intravenous cetuximab

DRUG

KQB198

Oral KQB198

Sponsors & Collaborators

  • Kumquat Biosciences Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-04
Primary Completion
2029-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06720987 on ClinicalTrials.gov