Brief Summary
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Brief Title
QTX3034 in Patients With KRAS G12D Mutation
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
415-599-3892
Central Contact Email
clinicaltrials@quantatx.com
Completion Date
Completion Date Type
Estimated
Conditions
Solid Tumors
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
Inclusion Criteria
Inclusion Criteria:
* 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
Inclusion/
* 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
Inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06227377
Org Class
Industry
Org Full Name
Quanta Therapeutics
Org Study Id
QTX3034-001
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
Primary Outcomes
Outcome Description
DLTs will be defined as the occurrence of any of the toxicities as described in the protocol
Outcome Measure
Number of participants with Dose Limiting Toxicities (DLTs)
Outcome Time Frame
up to 21 days
Outcome Description
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
Outcome Measure
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Outcome Time Frame
up to 2 years
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
up to 2 years
Outcome Measure
QTX3034 pharmacokinetic parameters in plasma
Outcome Description
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.
Outcome Time Frame
up to 2 years
Outcome Measure
Objective response rate (ORR)
Outcome Description
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.
Outcome Time Frame
up to 2 years
Outcome Measure
Duration of response (DOR)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Fernand Bteich
Investigator Email
fbteich@montefiore.org