Exploring a new medicine for advanced cancers
An Open-Label Phase 1 Study to Evaluate PF-08046032 as Monotherapy and Part of Combination Therapy in Participants With Advanced Malignancies
This study is testing a new medicine for advanced cancers to see if it works better alone or with another drug in adults who haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | sasanlimab |
| Locations | 3 sites (San Antonio, Texas and 2 other locations) |
| Trial ID | NCT06870487 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a new medication called PF-08046032, both alone and in combination with another drug, sasanlimab, in adults with advanced cancers, including specific types of lymphomas and solid tumors. The trial is divided into three parts: the first part tests PF-08046032 alone at increasing doses, the second part evaluates the combination of PF-08046032 and sasanlimab in patients who have either progressed on prior treatments or have not yet received standard therapies, and the third part further assesses this combination in selected tumor types. The goal is to determine the safety and effectiveness of these treatments in patients with advanced malignancies.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced lymphomas or solid tumors who have progressed on or after standard treatments.
Not a fit: Patients with early-stage cancers or those who have not received any 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 cancers that have not responded to existing therapies.
How similar studies have performed: Other studies have shown promise with similar approaches, particularly in targeting advanced malignancies with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: 1. Histological or cytological diagnosis of metastatic or unresectable malignancy: * Part A1: Participants with lymphomas (cHL, PTCL, large B-cell lymphoma) who have progressed on/after standard therapies * Part A2: Participants with solid tumors (NSCLC, HNSCC, melanoma, or other limited tumor types) who have progressed on or following prior immune checkpoint inhibitor if indicated and available * Part B: Participants with solid tumors who have either progressed on/after prior immune checkpoint inhibitor, or who have not received prior immune checkpoint inhibitor therapy * Part C: Participants with selected tumor type who have not received systemic anticancer treatment for the tumor type (including prior immune checkpoint inhibitor 2. Measurable disease as defined by Lugano Classification for lymphomas or RECIST 1.1 for solid tumors 3. Able to provide tumor tissue(s) as defined by the protocol depending on the Part of the study at enrollment 4. ECOG Performance Status score 0 or 1 EXCLUSION CRITERIA: 1. Ongoing peripheral neuropathy 2. History of significant immune-mediated adverse event considered related to prior immune-modulatory therapy 3. Known or suspected active autoimmune disease
Where this trial is running
San Antonio, Texas and 2 other locations
- NEXT Oncology — San Antonio, Texas, United States (Not_yet_recruiting)
- Fred Hutchinson Cancer Center. — Seattle, Washington, United States (Recruiting)
- University of Washington Medical Center- Montlake — Seattle, Washington, 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.