QTX3046 in Patients With KRAS G12D Mutations

Quanta Therapeutics

Status and phase

Active, not recruiting

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: QTX3046

Combination Product: Cetuximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06428500

QTX3046-101

Details and patient eligibility

About

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

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

240 participants in 4 patient groups

Part 1a: QTX3046 monotherapy dose escalation

Experimental group

Description:

QTX3046 will be administered orally at escalating doses as defined in the protocol based on dose level assignment

Treatment:

Drug: QTX3046

Part 1b: QTX3046 dose escalation in combination with cetuximab

Experimental group

Description:

QTX3046 will be administered orally at escalating doses as defined in the protocol in combination with intravenous cetuximab based on dose level assignment

Treatment:

Combination Product: Cetuximab

Drug: QTX3046

Part 2: QTX3046 monotherapy dose expansion

Experimental group

Description:

QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) based on cohort assignment

Treatment:

Drug: QTX3046

Part 3: QTX3046 dose expansion in combination with cetuximab

Experimental group

Description: