Status:
RECRUITING
A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Non Small Cell Lung
Carcinoma, Pancreatic Ductal
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or metastatic malignancies. This study is seeking ...
Eligibility Criteria
Inclusion
- This study is seeking participants who have the following tumor types and can provide tumor tissue samples as per below.
- Tumor types
- Monotherapy Dose Escalation (Part 1a) and Optimization (Part 2a) cohorts
- Advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC
- Must have progressive disease following at least 1 prior approved systemic therapy
- Monotherapy Dose Expansion (Part 3a)
- • Advanced or metastatic NSCLC or PDAC
- Combination Safety Evaluation (Part 1b) and Dose Optimization (Part 2b)
- Advanced or metastatic NSCLC or HNSCC
- May be either a) not received prior immunotherapy for the tumor type OR b) relapse/ refractory after prior immunotherapy
- Combination Dose Expansion (Part 3b)
- Unresectable locally advanced or metastatic HNSCC or NSCLC
- Must not have received prior systemic cytotoxic therapy in the locally advanced or metastatic setting (first-line setting)
- Must be treatment naïve to any immunotherapy
- NSCLC must have PD-L1 expression TPS \>=50%
- HNSCC must have PD-L1 expression CPS \>=1
- Tissue requirement
- Part 1 at lower doses: sufficient archival tissue collected within 12 months of enrollment for submission to central laboratory
- Part 1 at higher doses: de novo baseline tumor biopsy or archival tissue within 12 months of enrollment
- Part 1 backfill: de novo baseline and on-treatment tumor biopsies are required
- Part 2 and 3: de novo baseline or archival tissue within 6 months of enrollment
- Part 2 and 3: mandatory on-treatment tumor biopsy, if required by sponsor
- Measurable disease per RECIST v1.1
- Participants who meet the following might not be able to participate.
- History of Grade \>=3 immune mediated AE related to prior immune modulatory therapy and required immunosuppressive therapy
- Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- History of uveitis within the preceding 6 months
- Clinically significant Grade \>=3 neurodegenerative disease
- Grade 3 or higher pulmonary disease unrelated to underlying malignancy
- Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist
Exclusion
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT06974734
Start Date
May 6 2025
End Date
September 30 2029
Last Update
December 9 2025
Active Locations (20)
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1
Presbyterian/ St. Lukes Medical Center
Denver, Colorado, United States, 80218
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
3
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, United States, 06510
4
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States, 06510