PF-08046037 + Sasanlimab for Non-Small Cell Lung Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Autoimmune disease, Neurodegenerative disease, Pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Until disease progression or unacceptable toxicity

399 Participants Needed

Trial Summary

What is the purpose of this trial?

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 participants who: * have advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, or pancreatic ductal adenocarcinoma (PDAC); * are able to provide tumor tissue samples; * have measurable disease. All participants will receive while at the clinic PF-08046037 alone as an intravenous (IV) infusion (given directly into a vein) or with sasanlimab as a subcutaneous (SQ) injection (given under the skin) once every 3 weeks. Participants will continue to take the study drug(s) until their cancer is no longer responding or if the patient cannot safely take them. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for people with certain advanced cancers, including lung, skin, and pancreatic cancer. Participants must be able to provide tumor samples and have measurable disease. They will receive PF-08046037 alone or with sasanlimab during clinic visits every three weeks.

Inclusion Criteria

My cancer has worsened despite treatment.

I have advanced or metastatic NSCLC or PDAC.

I have advanced lung or head/neck cancer and haven't had immunotherapy or it didn't work.

Exclusion Criteria

Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist

I had a severe reaction to previous immune therapy that needed treatment.

I have an autoimmune disease that could worsen with immune-stimulating treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-08046037 alone as an IV infusion or with sasanlimab as a SQ injection every 3 weeks

Until disease progression or unacceptable toxicity

Regular visits at the study clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

30-37 days after the last study treatment

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Up to approximately 2 years

Treatment Details

Interventions

• PF-08046037
• sasanlimab

Trial Overview The study tests the safety and effects of PF-08046037 by itself or combined with sasanlimab in treating advanced malignancies. Treatments are administered intravenously (PF-08046037) or as a subcutaneous injection (sasanlimab).

Participant Groups

Group I: Part 3b Experimental Treatment 2 Interventions

PF-08046037 + sasanlimab dose expansion

Group II: Part 3a Experimental Treatment 1 Intervention

PF-08046037 monotherapy dose expansion

Group III: Part 2b Experimental Treatment 2 Interventions

PF-08046037 + sasanlimab dose optimization

Group IV: Part 2a Experimental Treatment 1 Intervention

PF-08046037 monotherapy dose optimization

Group V: Part 1b Experimental Treatment 2 Interventions

PF-08046037 +sasanlimab dose escalation

Group VI: Part 1a Experimental Treatment 1 Intervention

PF-08046037 monotherapy dose escalation

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University