QTX3034 in Patients With KRAS G12D Mutation

NCT06227377
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
250
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Lead sponsor
Quanta Therapeutics
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Start date
2024-02-05
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Number of sites
14
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Summary
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
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Short title
QTX3034 in Patients With KRAS G12D Mutation
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Official title
A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
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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
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-04-01
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First posted
2024-01-26
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Registry last updated
2026-04-27
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Primary completion date
2027-04-01
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Start date
2024-02-05
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Participants
250
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Participant count basis
Estimated
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Planned participants
250
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Protocol amendments
0
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Number of sites
14
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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
NCT06227377
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ClinicalTrials.gov ID
NCT06227377
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Registry record
Open registry record
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Allocation
Not randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. 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

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

    Timeframe: up to 2 years

    Defined 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

  1. QTX3034 pharmacokinetic parameters in plasma

    Timeframe: up to 2 years

    Plasma concentration data for QTX3034 will be used to evaluate PK parameters such as maximum concentration (Cmax), minimum concentration (Cmin), time to attain Cmax (Tmax), area under the concentration-time curve (AUC), elimination half-life (t1⁄2).

  2. 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.

  3. 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 mutation 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 1 prior systemic therapy
  • Evaluable or Measurable disease per RECIST 1.1.
  • Parts 2 and 3: Measurable disease per RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate organ function

  • Prior treatment with a KRAS inhibitor
  • Active brain metastases or carcinomatous meningitis
  • History of other malignancy within 2 years
  • Significant cardiovascular disease
  • Disease or disorder that may pose a risk to patient's safety

Other protocol-defined Inclusion/Exclusion Criteria may apply

Sources for eligibility
clinicaltrials.gov

  • UCLA Hematology/OncologyLos Angeles, United StatesRecruiting
  • Sarah Cannon Research Institute (SCRI)Denver, United StatesRecruiting
  • Yale Cancer CenterNew Haven, United StatesRecruiting
  • Florida Cancer SpecialistsSarasota, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • NYU Langone HealthNew York, United StatesRecruiting
  • Montefiore Medical CenterThe Bronx, United StatesRecruiting
  • Duke UniversityDurham, United StatesRecruiting
  • Stephenson Cancer CenterOklahoma City, United StatesRecruiting
  • SCRI- NashvilleNashville, United StatesRecruiting
  • MD AndersonHouston, United StatesRecruiting
  • START San Antonio, LLCSan Antonio, United StatesRecruiting
  • University of Utah, Huntsman Cancer CenterSalt Lake City, United StatesRecruiting
  • NEXT Oncology VirginiaFairfax, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)