Clinical trial

A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

NCT06428500

Name

QTX3046-101

Description

Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.

Trial arms

Trial start

2024-06-30

Estimated PCD

2027-07-01

Trial end

2027-07-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

QTX3046

QTX3046 will be administered at protocol defined dose.

Arms:

Part 1a: QTX3046 monotherapy dose escalation, Part 1b: QTX3046 dose escalation in combination with cetuximab, Part 2: QTX3046 monotherapy dose expansion, Part 3: QTX3046 dose expansion in combination with cetuximab

Cetuximab

Cetuximab will be administered at protocol defined dose.

Arms:

Part 1b: QTX3046 dose escalation in combination with cetuximab, Part 3: QTX3046 dose expansion in combination with cetuximab

Size

240

Primary endpoint

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

up to 2 years

Number of participants with Dose Limiting Toxicities (DLTs)

up to 21 days

Eligibility criteria

Inclusion Criteria: * Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

Updated at

2024-05-24

1 organization

2 products

1 indication

Organization

Product

Indication

Product