PF-07329640 for Solid Tumors

(LTbR Trial)

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn about the safety (the impact of the study drug on the participant's body), effects of the study drug alone or in combination with bevacizumab or sasanlimab, and to find the best dose. This study is seeking participants who have solid tumors that: * have advanced (cancer that doesn't disappear or stay away with treatment) or * has spread to other parts of the body (metastatic). This includes (but limited to) the following cancer types: * Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body. * Colorectal Cancer (CRC): This is a disease where cells in the colon or rectum grow out of control. * Urothelial Cancer (UC): This is a cancer that starts in the urinary systems. * Melanoma: Skin cancer that develops when melanocytes (the cells that give the skin its tan or brown color) start to grow out of control. All participants in this study will receive the study medication (PF-07329640) as an IV infusion (given directly into a vein) at the study clinic every week for repeating 28-day cycles. Depending on which part of the study participants are enrolled in they will receive the study medication (PF-07329640 alone or in combination with other anti-cancer medications (bevacizumab or sasanlimab). Bevacizumab is given in the clinic as IV infusion every two weeks and sasanlimab is given as a shot under the skin every 4 weeks. Participants can continue to take the study medication (PF-07329640) and bevacizumab until their cancer is no longer responding. Participants who are taking sasanlimab may receive it for up to 2 years. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective. Participants will be involved in this study for up to 4 years. During this time, they will have a study visit every week. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Participants with advanced or metastatic solid tumors, including NSCLC, CRC, UC, and melanoma. They will receive PF-07329640 via IV infusion weekly for 28-day cycles and may also get bevacizumab every two weeks or sasanlimab every four weeks.

Inclusion Criteria

I have NSCLC, tried or can't take standard treatments, and if I have mutations, I've tried or can't take targeted therapies.

My cancer has worsened despite previous anti-PD-(L)1 therapy.

My cancer is advanced, cannot be surgically removed, and has either spread or not responded to treatment.

Exclusion Criteria

Known or suspected hypersensitivity to specific components

I need immediate treatment for a brain tumor or cancer spread to my brain.

I haven't had cancer treatment in the last 4 weeks or 5 half-lives, whichever is shorter.

Treatment Details

Interventions

• bevacizumab (Monoclonal Antibodies)
• PF-07329640 (Virus Therapy)
• sasanlimab (Monoclonal Antibodies)

Trial Overview The trial is testing the safety and effects of PF-07329640 alone or combined with bevacizumab or sasanlimab on various cancers. It aims to determine the optimal dosing while monitoring participants' responses over up to four years.

Participant Groups

Group I: Part 2D: PF-07329640 (αLTβR) Experimental Treatment 1 Intervention

PF-07329640 (αLTβR) dose expansion in advanced solid tumors at prescribed dose and frequency in 28-day cycles

Group II: Part 2C: PF-07329640 (αLTβR) + SOC Experimental Treatment 1 Intervention

PF-07329640 (αLTβR) + SOC (anti-PD-1+ platinum-based chemo) dose expansion for αPDx-naïve NSCLC 1L at prescribed dose and frequency in 28-day cycles

Group III: Part 2B: PF-07329640 (αLTβR) + sasanlimab Experimental Treatment 2 Interventions

PF-07329640 (αLTβR) + sasanlimab dose expansion in NSCLC, melanoma, UC, and MSS CRC at prescribed dose and frequency in 28-day cycles

Group IV: Part 2A: PF-07329640 (αLTβR) + bevacizumab Experimental Treatment 2 Interventions

PF-07329640 (αLTβR) + bevacizumab dose expansion in NSCLC 2L+ and MSS CRC 2L+ at prescribed dose and frequency in 28-day cycles

Group V: Part 1C: PF-07329640 (αLTβR) + sasanlimab Experimental Treatment 2 Interventions

PF-07329640 (αLTβR) + sasanlimab dose escalation in NSCLC, melanoma, UC, and MSS CRC at prescribed dose and frequency in 28-day cycles

Group VI: Part 1B: PF-07329640 (αLTβR) + bevacizumab Experimental Treatment 2 Interventions

PF-07329640 (αLTβR) + bevacizumab dose escalation in NSCLC and MSS CRC at prescribed dose and frequency in 28-day cycles

Group VII: Part 1A: PF-07329640 (αLTβR) Monotherapy Experimental Treatment 1 Intervention

PF-07329640 (αLTβR) monotherapy at prescribed dose and frequency 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