QTX3034 in Patients With KRAS G12D Mutation

Quanta Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors

Treatments: Drug: QTX3034; Combination Product: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06227377

QTX3034-001

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 4 patient groups

Part 1a: QTX3034 monotherapy dose-escalation

Experimental group

Description:

QTX3034 will be administered at protocol defined dose based on cohort assignment

Treatment:

Drug: QTX3034

Part 1b: QTX3034 combination with cetuximab dose-escalation

Experimental group

Description:

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Treatment:

Combination Product: Cetuximab

Drug: QTX3034

Part 2: QTX3034 monotherapy dose-expansion

Experimental group

Description:

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Treatment:

Drug: QTX3034

Part 3: QTX3034 combination with cetuximab dose-expansion

Experimental group

Description:

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Treatment:

Combination Product: Cetuximab

Drug: QTX3034