QTX3046 in Patients With KRAS G12D Mutations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-30

Study Completion Date

2027-07-01

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1a: QTX3046 monotherapy dose escalation

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

Group Type EXPERIMENTAL

QTX3046

Intervention Type DRUG

QTX3046 will be administered at protocol defined dose.

Part 1b: QTX3046 dose escalation in combination with cetuximab

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

Group Type EXPERIMENTAL

QTX3046

Intervention Type DRUG

QTX3046 will be administered at protocol defined dose.

Cetuximab

Intervention Type COMBINATION_PRODUCT

Cetuximab will be administered at protocol defined dose.

Part 2: QTX3046 monotherapy dose expansion

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

Group Type EXPERIMENTAL

QTX3046

Intervention Type DRUG

QTX3046 will be administered at protocol defined dose.

Part 3: QTX3046 dose expansion in combination with cetuximab

QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) in combination with intravenous cetuximab based on cohort assignment

Group Type EXPERIMENTAL

QTX3046

Intervention Type DRUG

QTX3046 will be administered at protocol defined dose.

Cetuximab

Intervention Type COMBINATION_PRODUCT

Cetuximab will be administered at protocol defined dose.

Interventions

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QTX3046

QTX3046 will be administered at protocol defined dose.

Intervention Type DRUG

Cetuximab

Cetuximab will be administered at protocol defined dose.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No