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OpenTrials
Active, Not Recruiting

NCT Number: NCT06715124

QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sarah Cannon Research Institute, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

QTX3544

Drug

QTX3544 will be administered at protocol defined dose.

Cetuximab

Combination Product

Cetuximab will be administered at protocol defined dose.

Primary outcomes

  1. Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: 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)

    Time frame: up to 21 days

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

Secondary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Quanta Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Dec 4, 2024
Registry last updated
Mar 2, 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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