A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

NCT06720987 | Recruiting Phase 1 FDA Drug

• 1 other identifier: KQB365-101
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 11

Brief Summary

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are:

• What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198?
• Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor?
• What happens to KQB365 in the body? Participants will:
• Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198.
• Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

Conditions

KRAS G12C Mutation; KRAS G12S Mutation; Solid Tumor Malignancies; CRC (Colorectal Cancer)

Keywords

cetuximab; KQB365; KQB198

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 30 days after last dose of study treatment.

  From enrollment to the end of treatment

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

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

  up to 35 months

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

  ORR 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 35 months

Secondary Outcomes (9)

• Concentration-time curve (AUC)

  up to 35 months

• Maximum plasma concentration (Cmax)

  up to 35 months

• Time to maximum plasma concentration (tmax)

  up to 35 months

• Overall survival (OS)

  up to 35 months

• Progression-free survival (PFS)

  up to 35 months

Study Arms (7)

Monotherapy Dose Escalation (Part 1)

EXPERIMENTAL

Drug: KQB365 \- Intravenous KQB365

Drug: KQB365

Combo Therapy with Cetuximab Dose Escalation (Part 1)

EXPERIMENTAL

Drug: KQB365 - Intravenous KQB365 Drug: \- Intravenous cetuximab

Drug: KQB365; Drug: Cetuximab

Monotherapy Dose Expansion - RP2D (Part 2)

EXPERIMENTAL

Drug: KQB365 \- Intravenous KQB365

Drug: KQB365

Monotherapy Dose Expansion - RP2D-1 (Part 2)

EXPERIMENTAL

Drug: KQB365 \- Intravenous KQB365

Drug: KQB365

Combo Therapy with Cetuximab Dose Expansion - RP2D (Part 2)

EXPERIMENTAL

Drug: KQB365 - Intravenous KQB365 Drug: \- Intravenous cetuximab

Drug: KQB365; Drug: Cetuximab

Combo Therapy with Cetuximab Dose Expansion - RP2D-1 (Part 2)

EXPERIMENTAL

Drug: KQB365 - Intravenous KQB365 Drug: \- Intravenous cetuximab

Drug: KQB365; Drug: Cetuximab

Combo Therapy with KQB198 Dose Escalation (Part 1)

EXPERIMENTAL

Drug: KQB365 - Intravenous KQB365 Drug: \- Oral KQB198

Drug: KQB365; Drug: KQB198

Interventions

KQB365 DRUG

Intravenous KQB365

Combo Therapy with Cetuximab Dose Escalation (Part 1); Combo Therapy with Cetuximab Dose Expansion - RP2D (Part 2); Combo Therapy with Cetuximab Dose Expansion - RP2D-1 (Part 2); Combo Therapy with KQB198 Dose Escalation (Part 1); Monotherapy Dose Escalation (Part 1); Monotherapy Dose Expansion - RP2D (Part 2); Monotherapy Dose Expansion - RP2D-1 (Part 2)

Cetuximab DRUG

Intravenous cetuximab

Combo Therapy with Cetuximab Dose Escalation (Part 1); Combo Therapy with Cetuximab Dose Expansion - RP2D (Part 2); Combo Therapy with Cetuximab Dose Expansion - RP2D-1 (Part 2)

KQB198 DRUG

Oral KQB198

Combo Therapy with KQB198 Dose Escalation (Part 1)

Eligibility Criteria

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

You may qualify if:

• PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
• PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
• Unresectable or metastatic disease
• No available treatment with curative intent
• Adequate organ function
• Measurable disease per RECIST v1.1

You may not qualify if:

• Active primary central nervous system tumors
• Cardiac abnormalities
• Active interstitial lung disease
• Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts

Sponsors & Collaborators

• Kumquat Biosciences Inc.: lead

Study Sites (11)

Mayo Clinic, Phoenix

Phoenix, Arizona, 85054, United States

RECRUITING

Sarah Cannon Cancer Institute at HealthONE

Denver, Colorado, 80218, United States

RECRUITING

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Cleveland Clinic, Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

RECRUITING

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Sydney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Virginia, LLC

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Kumquat Clinical Development

CONTACT

(858) 214-2700; kumquatstudies@kumquatbio.com

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: December 3, 2024
• First Posted: December 6, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)