QTX3046 in Patients With KRAS G12D Mutations

NCT06428500
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
240
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Lead sponsor
Quanta Therapeutics
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Start date
2024-05-30
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Number of sites
5
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Summary
Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.
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Short title
QTX3046 in Patients With KRAS G12D Mutations
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Official title
A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-07-01
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First posted
2024-05-24
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Registry last updated
2025-07-25
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Primary completion date
2027-07-01
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Start date
2024-05-30
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Participants
240
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Participant count basis
Estimated
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Planned participants
240
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Protocol amendments
1
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Number of sites
5
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Quanta Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06428500
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ClinicalTrials.gov ID
NCT06428500
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: 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.

  2. Number of participants with Dose Limiting Toxicities (DLTs)

    Timeframe: up to 21 days

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

  1. Area under the plasma concentration-time curve (AUC) of QTX3046

    Timeframe: up to 2 years

    Plasma concentration data for QTX3046 will be used to evaluate the area under the plasma concentration-time curve (AUC) of QTX3046

  2. Peak plasma concentration of QTX3046 (Cmax)

    Timeframe: up to 2 years

    Plasma concentration data for QTX3046 will be used to evaluate peak plasma concentration (Cmax) of QTX3046

  3. Objective response rate (ORR)

    Timeframe: up to 2 years

    The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.

  4. Duration of response (DoR)

    Timeframe: up to 2 years

    Duration of response (DoR) is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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

Sources for eligibility
clinicaltrials.gov

  • South Texas Accelerated Research Therapeutics, LLC MidwestGrand Rapids, United States
  • Duke Cancer CenterDurham, United States
  • The University of Texas MD Anderson Cancer CenterHouston, United States
  • South Texas Accelerated Research Therapeutics, LLC San AntonioSan Antonio, United States
  • Huntsman Cancer Institute, University of UtahSalt Lake City, United States
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)