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Monoclonal Antibodies

QTX3046 + Cetuximab for Solid Tumors

Phase 1
Recruiting
Research Sponsored by Quanta Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Advanced solid tumors with at least one prior systemic therapy and evaluable and measurable disease per RECIST v1.1
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
Must not have
Active brain metastasis or carcinomatous meningitis
Active infection requiring intravenous (IV) antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing the safety and tolerance of a drug called QTX3046 either alone or in combination with another drug called cetuximab.

Who is the study for?
This trial is for adults with advanced solid tumors that have a specific genetic change called KRAS G12D mutation. They must have tried at least one treatment before and their disease should be measurable by medical imaging. People can't join if they don't meet the testing requirements or other specifics not listed here.
What is being tested?
The study is looking at how safe and tolerable QTX3046 is, either on its own or when used together with another cancer drug called Cetuximab. It's an early-stage (Phase 1) trial to see what effects these treatments have on patients.
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on safety, detailed side effects are being determined. Generally, drugs like QTX3046 and Cetuximab may cause skin reactions, infusion-related symptoms, and possibly affect liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced cancer with a history of treatment and my disease can be measured.
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My cancer has a KRAS G12D mutation confirmed by a certified test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active brain metastasis or carcinomatous meningitis.
Select...
I am currently on IV antibiotics for an infection.
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I have been treated with a KRAS inhibitor before.
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I have a serious heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Dose Limiting Toxicities (DLTs)
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Area under the plasma concentration-time curve (AUC) of QTX3046
Duration of response (DoR)
Objective response rate (ORR)
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 3: QTX3046 dose expansion in combination with cetuximabExperimental Treatment2 Interventions
QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) in combination with intravenous cetuximab based on cohort assignment
Group II: Part 2: QTX3046 monotherapy dose expansionExperimental Treatment1 Intervention
QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) based on cohort assignment
Group III: Part 1b: QTX3046 dose escalation in combination with cetuximabExperimental Treatment2 Interventions
QTX3046 will be administered orally at escalating doses as defined in the protocol in combination with intravenous cetuximab based on dose level assignment
Group IV: Part 1a: QTX3046 monotherapy dose escalationExperimental Treatment1 Intervention
QTX3046 will be administered orally at escalating doses as defined in the protocol based on dose level assignment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Quanta TherapeuticsLead Sponsor
1 Previous Clinical Trials
250 Total Patients Enrolled
~160 spots leftby Jul 2027
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