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Clinical Trials/NCT06715124
NCT06715124RecruitingPhase 1

A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

Quanta Therapeutics9 sites in 1 country237 target enrollmentStarted: January 14, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Sponsor
Enrollment
237
Locations
9
Primary Endpoint
Number of participants with Treatment-emergent Adverse Events (TEAEs)

Study Overview

Brief Summary

Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V 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.
  • 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

Arms & Interventions

Part 1a: QTX3544 monotherapy dose escalation

Experimental

QTX3544 will be administered at protocol defined dose based on cohort assignment

Intervention: QTX3544 (Drug)

Part 1b: QTX3544 dose escalation in combination with cetuximab

Experimental

QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Intervention: QTX3544 (Drug)

Part 1b: QTX3544 dose escalation in combination with cetuximab

Experimental

QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Intervention: Cetuximab (Combination Product)

Part 2: QTX3544 monotherapy dose expansion

Experimental

QTX3544 will be administered at protocol defined dose based on cohort assignment

Intervention: QTX3544 (Drug)

Part 3: QTX3544 dose expansion in combination with cetuximab

Experimental

QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Intervention: QTX3544 (Drug)

Part 3: QTX3544 dose expansion in combination with cetuximab

Experimental

QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Intervention: Cetuximab (Combination Product)

Outcomes

Primary Outcomes

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

Time Frame: up to 2 years

Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab.

Number of participants with Dose Limiting Toxicities (DLTs)

Time Frame: up to 21 days

DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.

Secondary Outcomes

  • Area under the plasma concentration-time curve (AUC) of QTX3544(up to 2 years)
  • Peak plasma concentration of QTX3544 (Cmax)(up to 2 years)
  • Objective response rate (ORR)(up to 2 years)
  • Duration of response (DoR)(up to 2 years)

Investigators

Sponsor
Quanta Therapeutics
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (9)

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