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RecruitingInterventionalPhase 1

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

NCT ID: NCT06507306Sponsor: Kumquat Biosciences Inc.Last updated: 2026-02-06

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

Arms & interventions

  • DrugKQB198

    Oral KQB198

  • DrugOsimertinib

    Oral Osimertinib

  • DrugAmivantamab

    Subcutaneous administration

Outcome measures

Primary

  • Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)

    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.

    Time frame: 28 Days

  • Recommended Phase 2 Dose (RP2D) (Part 1)

    Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.

    Time frame: up to 30 months

  • Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)

    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.

    Time frame: up to 30 months

Secondary

  • Concentration-time curve (AUC)

    Time frame: up to 30 months

  • Maximum plasma concentration (Cmax)

    Time frame: up to 30 months

  • Time to maximum plasma concentration (tmax)

    Time frame: up to 30 months

  • Overall survival (OS)

    Time frame: up to 30 months

  • Progression-free survival (PFS)

    Time frame: up to 30 months

  • Overall response rate (ORR)

    Time frame: up to 30 months

  • Duration of response (DOR)

    Time frame: up to 30 months

  • Time to response (TTR)

    Time frame: up to 30 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (10)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218

Recruiting

Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -

Orlando, Florida, 32827

Recruiting
Ingrid Acker · Contact

Florida Cancer Specialists - Sarasota

Sarasota, Florida, 34232

Recruiting

Henry Ford Health System

Detroit, Michigan, 48202

Recruiting
Jeevana Koneru · Contact

David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center

Long Island City, New York, 11101

Recruiting
Navkaran Singh · Contact

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219

Recruiting

Sarah Cannon and HCA Research Institute

Nashville, Tennessee, 37203

Recruiting
Derrick Porter · Contact

MD Anderson Cancer Center

Houston, Texas, 77030

Withdrawn

New Experimental Therapeutics of San Antonio - NEXT Oncology

San Antonio, Texas, 78229

Recruiting
Steven Alvarado · Contact

New Experimental Therapeutics of Virginia - NEXT Oncology

Fairfax, Virginia, 22031

Recruiting