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Clinical Trials in Italy / NCT06507306
Active, not recruiting Phase 1

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 Italy 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)

KQB198 →Osimertinib →Amivantamab →

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
No
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)

FacilityCityRegionStatus
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

📄 Tagrisso (osimertinib) drug profile →

More Kumquat Biosciences Inc. trials in Italy

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies Active, not recruiting

Other trials for the same condition

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer Recruiting
A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors Recruiting
Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors Active, not recruiting
A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers Active, not recruiting
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive 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 NCT06507306 on ClinicalTrials.gov ↗ ← All trials in Italy