A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

NCT06507306 · tracked via the Priya Life Science USA tracker

Sponsor

Kumquat Biosciences Inc.

Phase

Phase 1

Started

2024-06-03

Last updated

2026-09-02

Condition(s) studied

Solid Tumor, Adult

Investigational drug(s) / intervention(s)

KQB198OsimertinibAmivantamab

KQB198: Oral KQB198

Osimertinib: Oral Osimertinib

Amivantamab: Subcutaneous administration

Study summary

The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:

* What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?
* Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?
* What happens to KQB198 in the body?

Participants will:

* Take KQB198 daily, alone or in combination with another anti-cancer drug
* Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * PART 1 - Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1. * PART 1 - (Osimertinib and Amivantamab arms) and Part 2 Cohort A and Cohort B: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib * Part 3 - Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation * Unresectable or metastatic disease * No available treatment with curative intent * Adequate organ function * Measurable disease per RECIST 1.1. Exclusion Criteria: * Prior therapy with a similar mechanism of action to KQB198 * History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow * History of interstitial lung disease * Cardiac abnormalities

Primary outcome measure(s)

Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) — 28 Days
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 28 days after last dose of study treatment.
Recommended Phase 2 Dose (RP2D) (Part 1) — up to 30 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) (Parts 2 and 3) — up to 30 months
Objective response 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.

Trial sites (26)

Facility	City	Region
Sarah Cannon Research Institute at HealthONE	Denver	Colorado
Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -	Orlando	Florida
Florida Cancer Specialists - Sarasota	Sarasota	Florida
Henry Ford Health System	Detroit	Michigan
David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center	Long Island City	New York
The Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio
Sarah Cannon and HCA Research Institute	Nashville	Tennessee
New Experimental Therapeutics of San Antonio - NEXT Oncology	San Antonio	Texas
New Experimental Therapeutics of Virginia - NEXT Oncology	Fairfax	Virginia
Institut Paoli-Calmettes	Marseille	Bouches-du-Rhône
Institut de Cancerologie de l'Ouest - site St-Herblain	Saint-Herblain	Loire-Atlantique
CHU Bordeaux - Hopital Saint-Andre	Bordeaux	Nouvelle-Aquitane
IUCT-Oncopole	Toulouse	Occitaine
CHU de Nantes - Hopital Nord Laennec	Nantes	Pays de la Loire Region
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore	Rome	Lazio
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"	Naples	Italy
Hospital Universitari Quiron Dexeus Barcelona	Barcelona	Catalonia
Hospital Universitario Vall d'Hebron	Barcelona	Catalonia
New Experimental Therapeutics (NEXT) Oncology Barcelona	Barcelona	Spain
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos	Barcelona	Spain
Hospital Universitario Ramon y Cajal	Madrid	Spain
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC	Madrid	Spain
New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid	Madrid	Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz	Madrid	Spain
Hospital Quirónsalud Málaga	Málaga	Spain
Clinica Universidad de Navarra - Pamplona	Pamplona	Spain

On this site

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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 NCT06507306 on ClinicalTrials.gov ↗ ← All trials in the USA