Testing a new drug for advanced melanoma and other solid tumors
AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS
This study is testing a new drug called PF-08046031 to see if it can safely help people with advanced melanoma and other solid tumors that don't have any approved treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 185 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | Chemotherapy, immunotherapy |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT06799533 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a drug called PF-08046031 in patients with advanced melanoma and other solid tumors that lack approved treatment options. The trial consists of three parts: the first two parts focus on determining the appropriate dosage of the drug, while the third part assesses its safety and effectiveness in treating these cancers. Participants must have progressive disease after prior immunotherapy treatments and no available standard therapies. The study aims to provide insights into the potential of PF-08046031 as a treatment option for difficult-to-treat solid tumors.
Who should consider this trial
Good fit: Ideal candidates are individuals with metastatic or unresectable cutaneous melanoma who have experienced disease progression after at least one prior immunotherapy treatment.
Not a fit: Patients who have not received prior anti-PD-1/PD-L1 therapies or those with tumors that are resectable may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for patients with advanced melanoma and other solid tumors that currently have limited therapeutic alternatives.
How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced melanoma, but the specific drug PF-08046031 is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants in Part 1 (dose escalation) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti programmed death-1 (PD 1)/programmed death-ligand 1 (PD L1) immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator. * Participants in Part 2 (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti PD 1/PD L1 immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) but not more than 2 total prior lines of systemic therapy. * For Part 3 (dose expansion): Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from 1 of the following tumor types: cutaneous melanoma, NSCLC, HNSCC, esophageal cancer. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Measurable disease per RECIST v1.1 at baseline Exclusion Criteria: Active cerebral/meningeal disease related to the underlying malignancy. Previous exposure to CD228-targeted therapy, vedotin or an MMAE-containing agent, or any taxane containing regimen for advanced disease. Melanoma subtypes including uveal, and mucosal are excluded. Chemotherapy, definitive radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study intervention, or within 2 weeks prior to first dose of study intervention if the underlying disease has progressed on treatment Other protocol specific criteria might apply. -
Where this trial is running
Los Angeles, California and 4 other locations
- The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate — Los Angeles, California, United States (Recruiting)
- The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only) — Santa Monica, California, United States (Recruiting)
- Presbyterian/St. Luke's Medical Center — Denver, Colorado, United States (Recruiting)
- Florida Cancer Specialists — Orlando, Florida, United States (Recruiting)
- Sarah Cannon Research Institute at Florida Cancer Specialists — Orlando, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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.