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NCT Number: NCT06720987

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

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.

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Key information

Conditions

KRAS G12C Mutation CRC (Colorectal Cancer) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms KRAS G12S Mutation Neoplasms Neoplasms by Site Rectal Diseases Solid Tumor Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic, Phoenix, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

KQB365

Drug

Intravenous KQB365

Cetuximab

Drug

Intravenous cetuximab

KQB198

Drug

Oral KQB198

Primary outcomes

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

    Time frame: From enrollment to the end of treatment

    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.

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

    Time frame: up to 35 months

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

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

    Time frame: up to 35 months

    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.

Secondary outcomes

  1. Concentration-time curve (AUC)

    Time frame: up to 35 months

  2. Maximum plasma concentration (Cmax)

    Time frame: up to 35 months

  3. Time to maximum plasma concentration (tmax)

    Time frame: up to 35 months

  4. Overall survival (OS)

    Time frame: up to 35 months

  5. Progression-free survival (PFS)

    Time frame: up to 35 months

    using RECIST v1.1

  6. Overall response rate (ORR)

    Time frame: up to 35 months

    using RECIST v1.1

  7. Duration of response (DOR)

    Time frame: up to 35 months

    using RECIST v1.1

  8. Time to response (TTR)

    Time frame: up to 35 months

    using RECIST v1.1

  9. Disease control rate (DCR)

    Time frame: up to 35 months

    using RECIST v1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Kumquat Clinical Development

CONTACT

[email protected]

(858) 214-2700

Sponsors and collaborators

Lead sponsor

Kumquat Biosciences Inc.

Industry

Registry information

Official study title

A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Dec 6, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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