Testing CX-2051 for advanced solid tumors
An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors
PHASE1 · CytomX Therapeutics · NCT06265688
This study is testing a new drug called CX-2051 to see if it is safe and effective for adults with advanced solid tumors.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CytomX Therapeutics (industry) |
| Drugs / interventions | bevacizumab |
| Locations | 5 sites (Denver, Colorado and 4 other locations) |
| Trial ID | NCT06265688 on ClinicalTrials.gov |
What this trial studies
This first-in-human study aims to evaluate the safety, tolerability, and preliminary antitumor activity of CX-2051 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 (MTD), while the second part involves dose expansion to further assess safety and tolerability, along with initial evaluations of antitumor activity in specific cohorts. Participants will receive CX-2051 and will be monitored for responses and side effects.
Who should consider this trial
Good fit: Ideal candidates include 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 received certain prior treatments 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 approaches with novel agents have shown promise, but this specific treatment is being evaluated for the first time in humans.
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 * 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 * Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1 * Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload * Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1 * Elevated baseline laboratory values * Serious concurrent illness * Pregnant or breast feeding * Additional exclusion criteria may apply
Where this trial is running
Denver, Colorado and 4 other locations
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (RECRUITING)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Carolina BioOncology Institute, PLLC — Huntersville, North Carolina, United States (RECRUITING)
- Sarah Cannon Research Institute, LLC — Nashville, Tennessee, United States (RECRUITING)
- START San Antonio LLC — San Antonio, Texas, 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.
Conditions: Solid Tumor, Adult