PF-07820435 + Sasanlimab for Cancer

Recruiting at 13 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Systemic steroids, Immunosuppressants

Disqualifiers: Gastrointestinal disease, Pneumonitis, Autoimmune, others

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

Compensation: Varies

Number of Visits: 2

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced cancers (like lung, kidney, colorectal) who've tried standard treatments without success or can't tolerate them. They need at least one measurable tumor and must provide tissue samples. It's not open to those who haven't had specific prior therapies if available and tolerable.

Inclusion Criteria

I can provide samples of my tumor before (and possibly during) treatment.

My cancer is considered 'cold' and not typically treated with anti-PD-(L)1 therapy.

I have at least one tumor that can be measured and hasn't been treated with radiation.

Exclusion Criteria

I have not been on long-term immune-weakening medicines in the last 2 years.

I have or had lung inflammation or scarring treated with steroids.

I do not have ongoing serious stomach or intestinal problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive PF-07820435 as monotherapy or in combination with sasanlimab in 28-day cycles to determine the recommended dose

28 days per cycle

Visits on Day 1, Day 8, and Day 15 of each cycle

Expansion

Participants receive PF-07820435 at the recommended dose in combination with sasanlimab for further evaluation

28 days per cycle

Visits on Day 1 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• PF-07820435
• Sasanlimab

Trial Overview The study tests PF-07820435 alone and with Sasanlimab in patients with advanced solid tumors. Part 1 finds the best dose; Part 2 uses this dose to see how well it works in different cancer types.

How Is the Trial Designed?

Group I: Monotherapy dose escalation (Part 1A) Experimental Treatment 1 Intervention

Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles

Group II: Expansion (Part 2) - Tumor specific Arm B Experimental Treatment 2 Interventions

Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles

Group III: Expansion (Part 2) - Tumor specific Arm A Experimental Treatment 2 Interventions

Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles

Group IV: Expansion (Part 2) - Arm C Experimental Treatment 1 Intervention

Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles

Group V: Combination dose escalation (Part 1B) Experimental Treatment 2 Interventions

Participants will receive PF-07820435 orally at the prescribed dose and frequency, in combination with sasanlimab (subcutaneous injection) at a fixed dose once every 4 weeks in 28-day cycles

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