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Trial Title:
First In Human Study of CX-801 in Advanced Solid Tumors
NCT ID:
NCT06462794
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Pembrolizumab
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:
CX-801
Description:
Investigational drug
Arm group label:
CX-801
Arm group label:
CX-801 + pembrolizumab
Intervention type:
Drug
Intervention name:
pembrolizumab
Description:
Standard of Care Therapy
Arm group label:
CX-801 + pembrolizumab
Other name:
KEYTRUDA®
Summary:
The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety,
tolerability, and antitumor activity of CX-801 as monotherapy and in combination with
pembrolizumab in adult participants with advanced solid tumors.
Detailed description:
The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the
maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801
combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and
tolerability as well as preliminarily assess antitumor activity of CX-801 combination
therapy in indication-specific expansion cohorts.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Metastatic or locally advanced unresectable solid tumor that has progressed after
standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Measurable disease per RECIST v1.1
- Consent to fresh biopsy or if medically contraindicated, recent (within 6 months)
archival tumor tissue
- Adequate organ function
- Additional inclusion criteria may apply
Exclusion Criteria:
- Recent history (within last 2 years) of localized cancers that are not related to
the current cancer being treated
- Known active central nervous system (CNS) involvement by malignancy
- Prior immunotherapy discontinued due to grade 3 or higher immune related adverse
event
- Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of
study treatment
- Investigational drug or device within 4 weeks prior to first dose of study treatment
- Radiation within 2 weeks prior to first dose of study treatment
- Serious concurrent illness
- Pregnant or breast feeding
- Additional exclusion criteria may apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California San Francisco
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Pittsburgh Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Start date:
August 28, 2024
Completion date:
June 30, 2029
Lead sponsor:
Agency:
CytomX Therapeutics
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
CytomX Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06462794
