Testing CX-801 for advanced solid tumors
An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
This study is testing a new treatment called CX-801, alone and with another drug, to see if it can help adults with advanced solid tumors feel better and fight their cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 121 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CytomX Therapeutics Industry-sponsored |
| Drugs / interventions | Radiation, pembrolizumab |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Trial ID | NCT06462794 on ClinicalTrials.gov |
What this trial studies
This first-in-human study evaluates the safety, tolerability, and antitumor activity of CX-801, both alone and in combination with pembrolizumab, in adults with advanced solid tumors. The study consists of two parts: the first part focuses on dose escalation to determine the maximum tolerated dose of CX-801, while the second part involves dose expansion to further assess safety and preliminary antitumor activity in specific cohorts. Participants will undergo fresh biopsies or provide archival tumor tissue for analysis.
Who should consider this trial
Good fit: Ideal candidates are adults with metastatic or locally advanced unresectable solid tumors that have progressed after standard therapy.
Not a fit: Patients with recent localized cancers unrelated to the current cancer, known active CNS involvement, or those who have had severe adverse reactions to prior immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have not responded to standard therapies.
How similar studies have performed: Other studies involving similar immunotherapy combinations have shown promising results, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 PD-1/ PD-(L)1 inhibitor treatment 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
Where this trial is running
Pittsburgh, Pennsylvania and 1 other locations
- University of Pittsburgh Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Karen Deane
- Email: clinicaltrials@cytomx.com
- Phone: 650-515-3185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.