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

August 31, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 - Hôpital 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 Quirónsalud Málaga
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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