TerminatedPhase 1

A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines.

Stopped: Study terminated as part of strategic considerations and not based on safety concerns.

United States10 participantsStarted 2024-09-06

Plain-language summary

The purpose of this study is to learn about the: * safety (the effect of the study medicine on the participant's body), * effects of the study medicine alone or in combination with sasanlimab - * the best amount of the study medicine. This study is seeking participants who have solid tumors (An abnormal mass of tissue) that: * have advanced (cancer that does not disappear or stay away with treatment) or * are metastatic (has spread to other parts of the body). 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. * Renal Cell Carcinoma (RCC): This is a cancer that starts in the kidney. All participants in this study will receive the study medication (PF-07826390) as an IV infusion (given directly into a vein) at the study once every four weeks in 28 day cycles. The study participants depending on the group enrolled in, will receive the study medication (PF-07826390 alone or in combination with other anti-cancer medications (sasanlimab). Sasanlimab is given as a shot under the skin every 4 weeks. Participants can continue to take the study medication (PF-07826390) 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, participants will have a study visit every week. The participants after stopping the study medicine (at about 2 years) will be followed for another two years to see how the participants 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 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: 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: Participants with NSCLC (2A Arm 1 and 2B) must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. Participants with NSCLC who have not been previously treated with a prior anti-pd-(L) will be enrolled in Part 2C. * Participants with MSS CRC (Part 2A Arm 2) must have received fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF agent and anti-EGFR inhibitor (if RAS wildtype) and/or other molecularly targeted therapy if appropriate. Participants with RCC (Part 2A Arm 3) must have received prior tyrosine kinase inhibitor (TKI), anti-PD-(L)1 (if not receiving anti-PD-1 on protocol), anti-CTLA-4 (optional), hypoxia-inducible factor 2 alpha (HIF2a) inhibitor, or mTOR inhibitor or have documented intolerance to the standard therapy. * At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval…

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 and up to 90 days after last dose or start of new anticancer therapy, whichever occurred first.

PART 1 & 2: Number of participants with laboratory abnormalities

Timeframe: From start of the treatment and 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 IDNCT06546553

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-03

View on ClinicalTrials.gov More Neoplasms trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

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 and up to 90 days after last dose or start of new anticancer therapy, whichever occurred first.

PART 1 & 2: Number of participants with laboratory abnormalities

Timeframe: From start of the treatment and 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.