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Trial Title:
QTX3046 in Patients With KRAS G12D Mutations
NCT ID:
NCT06428500
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Cetuximab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QTX3046
Description:
QTX3046 will be administered at protocol defined dose.
Arm group label:
Part 1a: QTX3046 monotherapy dose escalation
Arm group label:
Part 1b: QTX3046 dose escalation in combination with cetuximab
Arm group label:
Part 2: QTX3046 monotherapy dose expansion
Arm group label:
Part 3: QTX3046 dose expansion in combination with cetuximab
Intervention type:
Combination Product
Intervention name:
Cetuximab
Description:
Cetuximab will be administered at protocol defined dose.
Arm group label:
Part 1b: QTX3046 dose escalation in combination with cetuximab
Arm group label:
Part 3: QTX3046 dose expansion in combination with cetuximab
Summary:
Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in
combination with cetuximab.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
South Texas Accelerated Research Therapeutics, LLC Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Contact:
Last name:
Olivia Sweeney
Phone:
616-389-6674
Email:
olivia.sweeney@startmidwest.com
Investigator:
Last name:
Nehal J. Lakhani, MD, PhD
Email:
Principal Investigator
Facility:
Name:
South Texas Accelerated Research Therapeutics, LLC San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Isabel Jimenez, RN, MSN
Phone:
210-593-5265
Email:
isabel.jimenez@startsa.com
Investigator:
Last name:
Amita Patnaik, MD, FRCP(C)
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute, University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Susan Sharry
Phone:
801-585-3453
Email:
susan.sharry@hci.utah.edu
Investigator:
Last name:
Ignacio Garrido-Laguna, MD, PhD, MBA
Email:
Principal Investigator
Start date:
May 30, 2024
Completion date:
July 1, 2027
Lead sponsor:
Agency:
Quanta Therapeutics
Agency class:
Industry
Source:
Quanta Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06428500
