Trial Title:
QTX3034 in Patients With KRAS G12D Mutation
NCT ID:
NCT06227377
Condition:
Solid Tumors
Conditions: Official terms:
Cetuximab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QTX3034
Description:
QTX3034 will be administered at protocol defined dose
Arm group label:
Part 1a: QTX3034 monotherapy dose-escalation
Arm group label:
Part 1b: QTX3034 combination with cetuximab dose-escalation
Arm group label:
Part 2: QTX3034 monotherapy dose-expansion
Arm group label:
Part 3: QTX3034 combination with cetuximab dose-expansion
Intervention type:
Combination Product
Intervention name:
Cetuximab
Description:
Cetuximab will be administered at protocol defined dose.
Arm group label:
Part 1b: QTX3034 combination with cetuximab dose-escalation
Arm group label:
Part 3: QTX3034 combination with cetuximab dose-expansion
Summary:
Phase 1 study to determine the safety and tolerability of QTX3034 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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Institute (SCRI)
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Front Desk
Phone:
720-754-2610
Email:
cann.ddudenvergeneral@sarahcannon.com
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ingrid Palma
Phone:
203-833-1034
Email:
ingrid.palma@yale.edu
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carly Taylor
Phone:
941-377-9993
Email:
Ctaylor@flcancer.com
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sabina Wlazlo
Phone:
919-668-1861
Email:
sabina.wlazlo@duke.edu
Facility:
Name:
SCRI- Nashville
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
askSarah
Phone:
844-482-4812
Email:
SCRI.Webmaster@scri.com
Facility:
Name:
MD Anderson
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ly Nguyen
Phone:
713-563-1930
Email:
LMNguyen1@mdanderson.org
Facility:
Name:
South Texas Accelerated Research Therapeutics
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
Facility:
Name:
University of Utah, Huntsman Cancer Center
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
Facility:
Name:
NEXT Oncology Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Blake Patterson
Phone:
703-783-4505
Email:
bpatterson@nextoncology.com
Start date:
February 5, 2024
Completion date:
April 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/NCT06227377
