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

NCT06507306 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: KQB198-101
• Study Type: interventional
• Target: 92
• Locations: 4 countries
• Sites: 26

Brief 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

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (3)

• 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.

  28 Days

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

  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)

  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 Outcomes (8)

• Concentration-time curve (AUC)

  up to 30 months

• Maximum plasma concentration (Cmax)

  up to 30 months

• Time to maximum plasma concentration (tmax)

  up to 30 months

• Overall survival (OS)

  up to 30 months

• Progression-free survival (PFS)

  up to 30 months

Study Arms (5)

Monotherapy Dose Escalation

EXPERIMENTAL

Drug: KQB198

Combo Therapy Dose Escalation

EXPERIMENTAL

Drug: KQB198; Drug: Osimertinib; Drug: Amivantamab

Combo Therapy Dose Expansion - RP2D

EXPERIMENTAL

Drug: KQB198; Drug: Osimertinib; Drug: Amivantamab

Combo Therapy Dose Expansion - RP2D-1

EXPERIMENTAL

Drug: KQB198; Drug: Osimertinib; Drug: Amivantamab

Combo Therapy Dose Expansion OBD

EXPERIMENTAL

Drug: KQB198; Drug: Osimertinib; Drug: Amivantamab

Interventions

KQB198 DRUG

Oral KQB198

Combo Therapy Dose Escalation; Combo Therapy Dose Expansion - RP2D; Combo Therapy Dose Expansion - RP2D-1; Combo Therapy Dose Expansion OBD; Monotherapy Dose Escalation

Osimertinib DRUG

Oral Osimertinib

Also known as: Tagrisso

Combo Therapy Dose Escalation; Combo Therapy Dose Expansion - RP2D; Combo Therapy Dose Expansion - RP2D-1; Combo Therapy Dose Expansion OBD

Amivantamab DRUG

Subcutaneous administration

Combo Therapy Dose Escalation; Combo Therapy Dose Expansion - RP2D; Combo Therapy Dose Expansion - RP2D-1; Combo Therapy Dose Expansion OBD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kumquat Biosciences Inc.: lead

Study Sites (26)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

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

Orlando, Florida, 32827, United States

Location

Florida Cancer Specialists - Sarasota

Sarasota, Florida, 34232, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

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

Long Island City, New York, 11101, United States

Location

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Sarah Cannon and HCA Research Institute

Nashville, Tennessee, 37203, United States

Location

New Experimental Therapeutics of San Antonio - NEXT Oncology

San Antonio, Texas, 78229, United States

Location

New Experimental Therapeutics of Virginia - NEXT Oncology

Fairfax, Virginia, 22031, United States

Location

Institut Paoli-Calmettes

Marseille, Bouches-du-Rhône, 13009, France

Location

Institut de Cancerologie de l'Ouest - site St-Herblain

Saint-Herblain, Loire-Atlantique, 44800, France

Location

CHU Bordeaux - Hopital Saint-Andre

Bordeaux, Nouvelle-Aquitane, 33000, France

Location

IUCT-Oncopole

Toulouse, Occitaine, 31059, France

Location

CHU de Nantes - Hopital Nord Laennec

Nantes, Pays de la Loire Region, 44000, France

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

Rome, Lazio, 00168, Italy

Location

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Naples, 80131, Italy

Location

Hospital Universitari Quiron Dexeus Barcelona

Barcelona, Catalonia, 08028, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Location

New Experimental Therapeutics (NEXT) Oncology Barcelona

Barcelona, 08023, Spain

Location

South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos

Barcelona, 08023, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC

Madrid, 28040, Spain

Location

New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid

Madrid, 28223, Spain

Location

South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

Madrid, Spain

Location

Hospital Quirónsalud Málaga

Málaga, 29004, Spain

Location

Clinica Universidad de Navarra - Pamplona

Pamplona, 31008, Spain

Location

MeSH Terms

Interventions

osimertinib; amivantamab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 18, 2024
• Study Start: June 3, 2024
• Primary Completion: July 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

ES (10); FR (5); US (9); IT (2)