Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in the USA / NCT07542704
Recruiting Phase 1

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

NCT07542704 · tracked via the Priya Life Science USA tracker
Sponsor
Kumquat Biosciences Inc
Phase
Phase 1
Started
2026-05-27
Last updated
2026-11-03

Condition(s) studied

Advanced Solid TumorsColorectal Cancer (CRC)Non-Small Cell Lung CancerUterine CancerKRAS G12C MutationsKRAS G12S Mutations

Investigational drug(s) / intervention(s)

KQB368

KQB368: Oral KQB368

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
* 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

Primary outcome measure(s)

  • Primary Objective — 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.

Trial sites (14)

FacilityCityRegionStatus
START Los Angeles Los Angeles California Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
John Theurer Cancer Center at Hackensack UMC Hackensack New Jersey Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
UH Cleveland Medical Center Cleveland Ohio Recruiting
Providence Cancer Institute Portland Oregon Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
NEXT Oncology Austin Austin Texas Recruiting
START Dallas Fort Worth Dallas Texas Recruiting
START San Antonio San Antonio Texas Recruiting
University of Utah - Huntsman Cancer Institute Salt Lake City Utah Recruiting
NEXT Oncology Virginia Fairfax Virginia Recruiting

More Kumquat Biosciences Inc. trials in the USA

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies Active, not recruiting
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies Active, not recruiting
KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line) Recruiting
A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies Recruiting
A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies Recruiting

Other trials for the same condition

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104). Active, not recruiting
Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours. Recruiting
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC Recruiting
A Study of MGC028 in Participants With Advanced Solid Tumors Recruiting
PAS-004 in Patients With Advanced Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07542704 on ClinicalTrials.gov ↗ ← All trials in the USA