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Recruiting NCT06720987

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

Phase I Interventional KRAS G12C Mutation KRAS G12S Mutation Solid Tumor Malignancies CRC (Colorectal Cancer)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KQB365, Cetuximab, KQB198.
Who it may be relevant to
Registry conditions: KRAS G12C Mutation, KRAS G12S Mutation, Solid Tumor Malignancies, CRC (Colorectal Cancer). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug KQB365
    Intravenous KQB365
  • Drug Cetuximab
    Intravenous cetuximab
  • Drug KQB198
    Oral KQB198

Primary outcome measures

  • 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]
  • Recommended Phase 2 Dose (RP2D) (Part 1) [Time frame: up to 35 months]
  • Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2) [Time frame: up to 35 months]
Secondary outcome measures (9)
  • Concentration-time curve (AUC) [Time frame: up to 35 months]
  • Maximum plasma concentration (Cmax) [Time frame: up to 35 months]
  • Time to maximum plasma concentration (tmax) [Time frame: up to 35 months]
  • Overall survival (OS) [Time frame: up to 35 months]
  • Progression-free survival (PFS) [Time frame: up to 35 months]
  • Overall response rate (ORR) [Time frame: up to 35 months]
  • Duration of response (DOR) [Time frame: up to 35 months]
  • Time to response (TTR) [Time frame: up to 35 months]
  • Disease control rate (DCR) [Time frame: up to 35 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 11 centers
  • Mayo Clinic, Phoenix — Phoenix
  • Sarah Cannon Cancer Institute at HealthONE — Denver
  • Mayo Clinic, Jacksonville — Jacksonville
  • Dana Farber Cancer Institute — Boston
  • START Midwest — Grand Rapids
  • Mayo Clinic, Rochester — Rochester
  • Cleveland Clinic, Taussig Cancer Institute — Cleveland
  • OU Health Stephenson Cancer Center — Oklahoma City
  • … and 3 more centers

Identifiers

NCT: NCT06720987 · KQB365-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗