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

NCT07542704 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: KQB368-101
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Conditions

Advanced Solid Tumors; Colorectal Cancer (CRC); Non-Small Cell Lung Cancer; Uterine Cancer; KRAS G12C Mutations; KRAS G12S Mutations

Keywords

KQB368

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  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.

  Up to 44 months

Secondary Outcomes (9)

• 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

Study Arms (1)

Monotherapy Dose Escalation

EXPERIMENTAL

Drug: KQB368

Interventions

KQB368 DRUG

Oral KQB368

Monotherapy Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kumquat Biosciences Inc.: lead
• Worldwide Clinical Trials: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Kumquat Clinical Development Telephone

CONTACT

858.214.2700; kumquatstudies@kumquatbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 21, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share