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Monoclonal Antibodies

Part 2: QTX3034 monotherapy dose-expansion 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

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial aims to test if QTX3034 is safe to use alone or together with cetuximab.

Who is the study for?

This trial is for adults with advanced solid tumors that have a specific KRAS G12D mutation, confirmed by certified testing. Participants must have tried at least one systemic therapy before and should be in good physical condition (ECOG status 0 or 1). They need to have measurable disease as defined by RECIST criteria and their organs must function well.Check my eligibility

What is being tested?

The study is evaluating the safety of QTX3034 alone or when used together with cetuximab. It's an early-stage (Phase 1) trial aimed at understanding how patients tolerate these treatments and determining appropriate dosages.See study design

What are the potential side effects?

Potential side effects are not detailed here but generally, drugs like QTX3034 and cetuximab can cause skin reactions, infusion-related discomfort, fatigue, low blood counts leading to increased infection risk, and possibly liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is advanced or has spread, and tests show a KRAS G12D mutation.

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I have advanced cancer and have received at least one treatment before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Duration of response (DOR)

Objective response rate (ORR)

QTX3034 pharmacokinetic parameters in plasma

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 3: QTX3034 combination with cetuximab dose-expansionExperimental Treatment2 Interventions

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

Group II: Part 2: QTX3034 monotherapy dose-expansionExperimental Treatment1 Intervention

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

Group III: Part 1b: QTX3034 combination with cetuximab dose-escalationExperimental Treatment2 Interventions

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

Group IV: Part 1a: QTX3034 monotherapy dose-escalationExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Quanta TherapeuticsLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"The information provided on clinicaltrials.gov affirms the ongoing patient recruitment for this particular trial. The trial was initially listed on 2/5/2024 and last revised on the same date."

Answered by AI

What is the current number of individuals receiving treatment within this specific clinical trial?

"Indeed, the details available on clinicaltrials.gov affirm that this trial is currently in the recruitment phase. Initial information about the clinical study was uploaded on February 5th, 2024, with the latest update made also on February 5th, 2024. The research aims to enroll a total of 250 participants from a single site."

Answered by AI

What is the safety profile of Part 1b: QTX3034 in combination with cetuximab using dose-escalation for individuals undergoing treatment?

"When assessing the safety of Part 1b involving QTX3034 in combination with cetuximab through dose escalation, our team at Power rated it as a 1 on the scale. This Phase 1 trial has limited evidence supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

QTX3034 in Patients With KRAS G12D Mutation

2024. "QTX3034 in Patients With KRAS G12D Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06227377.

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