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

July 26, 2026 updated by: Kumquat Biosciences Inc.

A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13009
        • Institut Paoli-Calmettes
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, France, 44800
        • Institut de Cancerologie de l'Ouest - site St-Herblain
    • Nouvelle-Aquitane
      • Bordeaux, Nouvelle-Aquitane, France, 33000
        • CHU Bordeaux - Hopital Saint-Andre
    • Occitaine
      • Toulouse, Occitaine, France, 31059
        • IUCT-Oncopole
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • CHU de Nantes - Hopital Nord Laennec
  • Italy
      • Naples, Italy, 80131
        • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
  • Spain
      • Barcelona, Spain, 08023
        • New Experimental Therapeutics (NEXT) Oncology Barcelona
      • Barcelona, Spain, 08023
        • South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain
        • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
      • Madrid, Spain, 28040
        • South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
      • Madrid, Spain, 28223
        • New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid
      • Málaga, Spain, 29004
        • Hospital QuironSalud Malaga
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Catalonia, Spain, 08028
        • Hospital Universitari Quiron Dexeus Barcelona
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Sarah Cannon Research Institute at HealthONE
    • Florida
      • Orlando, Florida, United States, 32827
        • Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists - Sarasota
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New York
      • Long Island City, New York, United States, 11101
        • David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Center for Research and Education at The Christ Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon and HCA Research Institute
    • Texas
      • San Antonio, Texas, United States, 78229
        • New Experimental Therapeutics of San Antonio - NEXT Oncology
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • New Experimental Therapeutics of Virginia - NEXT Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy Dose Escalation
Drug: KQB198
Oral KQB198
Experimental: Combo Therapy Dose Escalation
Drug: KQB198
Oral KQB198
Drug: Osimertinib
Oral Osimertinib
Other Names:
  • Tagrisso
Drug: Amivantamab
Subcutaneous administration
Experimental: Combo Therapy Dose Expansion - RP2D
Drug: KQB198
Oral KQB198
Drug: Osimertinib
Oral Osimertinib
Other Names:
  • Tagrisso
Drug: Amivantamab
Subcutaneous administration
Experimental: Combo Therapy Dose Expansion - RP2D-1
Drug: KQB198
Oral KQB198
Drug: Osimertinib
Oral Osimertinib
Other Names:
  • Tagrisso
Drug: Amivantamab
Subcutaneous administration
Experimental: Combo Therapy Dose Expansion OBD
Drug: KQB198
Oral KQB198
Drug: Osimertinib
Oral Osimertinib
Other Names:
  • Tagrisso
Drug: Amivantamab
Subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
Time Frame: 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.
28 Days
Recommended Phase 2 Dose (RP2D) (Part 1)
Time Frame: up to 30 months
Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
up to 30 months
Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)
Time Frame: 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.
up to 30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: up to 30 months
up to 30 months
Duration of response (DOR)
Time Frame: up to 30 months
up to 30 months
Overall survival (OS)
Time Frame: up to 30 months
up to 30 months
Concentration-time curve (AUC)
Time Frame: up to 30 months
up to 30 months
Maximum plasma concentration (Cmax)
Time Frame: up to 30 months
up to 30 months
Time to maximum plasma concentration (tmax)
Time Frame: up to 30 months
up to 30 months
Overall response rate (ORR)
Time Frame: up to 30 months
up to 30 months
Time to response (TTR)
Time Frame: up to 30 months
up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kumquat Biosciences Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KQB198-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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