TerminatedPhase 1

A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination

Stopped: Strategic business decision

United States, Puerto Rico4 participantsStarted 2024-05-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor * Part 1: * Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible. * Part 1B \& C: Participants either meeting Part 1A criterion, or participants with "cold" solid tumors where anti-PD-(L)1 therapy is not an established treatment * Part 2: * Part 2A: * Cohort 1: Participants with NSCLC must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. NSCLC participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies. * Cohort 2: Participants with MSS CRC must have received at least fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF agent (if not receiving anti-VEGF on protocol), and anti-epidermal growth factor receptor (EGFR) inhibitor (if RAS wildtype) and/or other molecularly targeted therapy if appropriate. * Part 2B: * NSCLC (2L+) participants as described above in Part 2A * MSS CRC (2L+) participants as described above in Part 2A * UC (2L+) participants must have received prior platinum-based chemotherapy, anti…

What they're measuring

PART 1: Number of participants with Dose-limiting toxicities (DLT)

Timeframe: First cycle, Day 1 up to Day 28

PART 1 & 2: Incidence of Adverse Events (AE)s

Timeframe: From start of the treatment up to 90 days after last dose or start of new anticancer therapy, whichever occurred first

To: PART 1 & 2: Number of participants with laboratory abnormalities

Timeframe: From start of treatment up to 90 days after last dose or start of new anticancer therapy, whichever occurred first

Part 2: "Objective Response - Number of Participants With Objective Response "

Timeframe: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'

Trial details

NCT IDNCT06448364

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-15

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