QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

NCT06715124
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
237
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Lead sponsor
Quanta Therapeutics
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Start date
2025-01-14
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Number of sites
10
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Summary
Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.
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Short title
QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
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Official title
A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-01-02
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First posted
2024-12-04
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Registry last updated
2026-03-02
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Primary completion date
2027-01-02
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Start date
2025-01-14
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Participants
237
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Participant count basis
Estimated
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Planned participants
237
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Protocol amendments
3
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Number of sites
10
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Quanta Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06715124
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ClinicalTrials.gov ID
NCT06715124
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: up to 2 years

    Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab.

  2. Number of participants with Dose Limiting Toxicities (DLTs)

    Timeframe: up to 21 days

    DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.

  1. Area under the plasma concentration-time curve (AUC) of QTX3544

    Timeframe: up to 2 years

    Plasma concentration data for QTX3544 will be used to evaluate the area under the concentration-time curve (AUC) of QTX3544.

  2. Peak plasma concentration of QTX3544 (Cmax)

    Timeframe: up to 2 years

    Plasma concentration data for QTX3544 will be used to evaluate peak plasma concentration (Cmax) of QTX3544.

  3. Objective response rate (ORR)

    Timeframe: up to 2 years

    The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.

  4. Duration of response (DoR)

    Timeframe: up to 2 years

    DoR is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V mutations 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 one prior systemic therapy.
  • Evaluable and measurable disease per RECIST v1.1.
  • Part 2 and 3: Measurable disease per RECIST v1.1.

  • Active brain metastasis or carcinomatous meningitis
  • Significant cardiovascular disease
  • Active infection requiring intravenous (IV) antibiotics
  • Prior treatment with a KRAS inhibitor

Other protocol-defined Inclusion/Exclusion Criteria may apply

Sources for eligibility
clinicaltrials.gov

  • Sarah Cannon Research InstituteDenver, United States
  • Yale Cancer CenterNew Haven, United States
  • Florida Cancer Specialists & Research InstituteSarasota, United States
  • South Texas Accelerated Research Therapeutics, LLC MidwestGrand Rapids, United States
  • Duke Cancer CenterDurham, United States
  • Sarah Cannon Research InstituteNashville, United States
  • The University of Texas MD Anderson Cancer CenterHouston, United States
  • South Texas Accelerated Research Therapeutics, LLC San AntonioSan Antonio, United States
  • Huntsman Cancer Institute, University of UtahSalt Lake City, United States
  • South Texas Accelerated Research Therapeutics Mountain Region, LLCWest Valley City, United States
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)