Recruiting NCT06227377
QTX3034 in Patients With KRAS G12D Mutation
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: QTX3034, Cetuximab.
- Who it may be relevant to
- Registry conditions: Solid Tumors. 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 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
Overview
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Interventions
- Drug QTX3034
QTX3034 will be administered at protocol defined dose - Combination product Cetuximab
Cetuximab will be administered at protocol defined dose.
Primary outcome measures
- Number of participants with Dose Limiting Toxicities (DLTs) [Time frame: up to 21 days]
- Number of participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: up to 2 years]
Secondary outcome measures (3)
- QTX3034 pharmacokinetic parameters in plasma [Time frame: up to 2 years]
- Objective response rate (ORR) [Time frame: up to 2 years]
- Duration of response (DOR) [Time frame: up to 2 years]
Eligibility criteria
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
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
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 14 centers
- UCLA Hematology/Oncology — Los Angeles
- Sarah Cannon Research Institute (SCRI) — Denver
- Yale Cancer Center — New Haven
- Florida Cancer Specialists — Sarasota
- Moffitt Cancer Center — Tampa
- NYU Langone Health — New York
- Montefiore Medical Center — The Bronx
- Duke University — Durham
- … and 6 more centers
Identifiers
NCT: NCT06227377 · QTX3034-001