A Phase I Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation

Study Identifier:
QTX3034-001
CT.gov Identifier:
NCT06227377
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.

To evaluate QTX3034 for the treatment of cancer.

Following identification of a RP2D, QTX3034 will be evaluated in dose-expansion cohorts of up to 30 patients with various KRASG12D mutated tumor types to determine preliminary activity: pancreatic cancer, CRC, non-small cell lung cancer and endometrial cancer. To further optimize the recommended dose, patients will be randomized between two dose levels in the pancreatic cancer cohort. QTX3034 plus cetuximab will be explored following identification of a recommended combination dose in patients with CRC.

The Phase 1 dose escalation portion of the clinical trial includes two parts: evaluation of QTX3034 monotherapy at doses ranging from 75 mg BID to 1200 mg BID in patients with advanced or metastatic solid tumors (n=42), and evaluation of QTX3034 at doses ranging from 150 mg BID to 1200 mg BID in combination with cetuximab in patients with advanced or metastatic CRC and PDAC (n=29).

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.
  • Solid Tumor
    • 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.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1a
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  • Drug: Experimental: Part 1b
  • Drug: Combination Product: Cetuximab
  • Drug: Experimental: Part 2
  • Drug: Experimental: Part 3
  • Drug: Part 1 consists of two dose-escalation arms: QTX3034 monotherapy (advanced solid tumors) and QTX3034 plus cetuximab (CRC) and will enroll 3-4 subjects per cohort in a Bayesian Logistic Regression Model (BLRM) design. QTX3034 will be administered orally in 21-day cycles until disease progression, intolerable toxicity, or withdrawal from treatment. Exploratory paired biopsies will be collected in Cycle 2 in a group of patients in the dose-escalation phase. Serial ctDNA will be collected in all patients.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • - Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D
    • mutation identified through molecular testing (NGS- or PCR-based) with a Clinical
    • Laboratory Improvement Amendments-certified (or equivalent) diagnostic
    • - Part 1: - Advanced solid tumors with at least 1 prior systemic therapy
    • - Evaluable or Measurable disease per RECIST 1.1.
    • - Parts 2 and 3: Measurable disease per RECIST 1.1.
    • - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    • - Adequate organ function
    Exclusion criteria
    • - Prior treatment with a KRAS inhibitor
    • - Active brain metastases or carcinomatous meningitis
    • - History of other malignancy within 2 years
    • - Significant cardiovascular disease
    • - Disease or disorder that may pose a risk to patient's safety
    • Other protocol-defined Inclusion/Exclusion Criteria may apply

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor