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

Study Identifier:
KQB365-101
CT.gov Identifier:
NCT06720987
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.
Medical Condition
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.
Gene Mutations
Solid Tumor
Bowel (Colorectal)
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 I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Combo Therapy with Cetuximab Dose Escalation (Part 1)
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Drug: Drug: KQB365 - Intravenous KQB365
Drug: Drug:
Drug: \- Intravenous cetuximab
Drug: Drug: Cetuximab
Drug: Intravenous cetuximab
Drug: Drug: KQB365
Drug: Intravenous KQB365
Drug: EXPERIMENTAL: Combo Therapy with Cetuximab Dose Expansion - RP2D-1 (Part 2)
Drug: EXPERIMENTAL: Combo Therapy with Cetuximab Dose Expansion - RP2D (Part 2)
Drug: EXPERIMENTAL: Combo Therapy with KQB198 Dose Escalation (Part 1)
Drug: \- Oral KQB198
Drug: Drug: KQB198
Drug: Oral KQB198
Drug: EXPERIMENTAL: Monotherapy Dose Escalation (Part 1)
Drug: \- Intravenous KQB365
Drug: EXPERIMENTAL: Monotherapy Dose Expansion - RP2D-1 (Part 2)
Drug: EXPERIMENTAL: Monotherapy Dose Expansion - RP2D (Part 2)
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Manish Sharma
Status
Recruiting
Condition(s) Treated at Site
Gene Mutations
Solid Tumor
Bowel (Colorectal)