Overview
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-07921585) in people with cancer that has advanced or spread to other parts of the body.
This study is seeking participants who have any of the following cancer types:
- non-small cell lung cancer
- colorectal cancer
- bladder cancer
- melanoma (a type of skin cancer)
- kidney cancer
- head and neck cancer Participants will receive the study medicine PF-07921585 alone or in combination with another study medicine called sasanlimab at the study clinic.
PF-07921585 will be given as an infusion into a vein or as shots under the skin, once every 3 weeks. Sasanlimab will be given as shots under the skin, also once every 3 weeks.
The experiences of participants receiving the study medicine will be studied to help see if the study medicine is safe and effective. Participants may receive study medicine for up to 2 years, depending on how the cancer responds to the study treatment. Participants may continue receiving study medicine after 2 years if there are any benefits from the study treatment. Participants will attend visits once every 3 weeks with the first 9 weeks having more frequent visits, to check the safety of the study treatment.
Description
The study contains 3 parts:
Part 1: dose escalation of PF-07921585 as single agent to determine the monotherapy recommended dose for further study.
Part 2: dose escalation of PF-07921585 in combination with the anti-PD 1 inhibitor sasanlimab and potentially other anti-cancer agents, in order to determine the recommended dose for expansion of the combination.
Part 3: dose optimization/ expansion will evaluate PF-07921585 in combination with sasanlimab, and potentially other anti-cancer agents. After identification of the recommended dose for expansion in Part 2, participants with select solid tumors will be enrolled into 3-4 cohorts as follows:
- Cohort 1: Melanoma
- Cohort 2: Microsatellite stable (MSS) metastatic colorectal cancer
- Cohort 3: Non-small cell lung cancer (NSCLC)
- Cohort 4: Solid tumor, tumor types and clinical setting to be determined based on emerging data.
Eligibility
Key Inclusion Criteria:
- Participants aged ≥18 years or older at the time of informed consent.
- Tumor types and prior treatment requirements: Participants entering Parts 2 and 3
must have at least 1 measurable lesion.
Part 1 and Part 2:
Eligible advanced/metastatic tumor types include NSCLC, urothelial carcinoma (UC), renal cell carcinoma (RCC), melanoma, head and neck squamous cell carcinoma (HNSCC), and microsatellite stable colorectal cancer (MSS-CRC). Participants must have demonstrated radiographic progression on standard treatment(s) for their cancer
Part 3:
- Cohort 1: Participants with metastatic melanoma with resistance to checkpoint inhibitor therapy and BRAF/MEKi.
- Cohort 2: Participants with metastatic MSS-CRC.
- Cohort 3: Participants with previously untreated metastatic NSCLC.
- ECOG PS 0 or 1.
Key Exclusion Criteria:
- Participants with any other active malignancy within 3 years prior to enrollment.
- Known or suspected hypersensitivity to, or severe allergic history of, human albumin or anti-PD-(L)1 therapy.
- History of Grade ≥3 immune-related AE (irAE) or unresolved irAEs prior to first dose of study intervention. Exception: vitiligo and endocrinopathy that is controlled with hormonal therapy.
- History of venous thromboembolic event <12 weeks prior to starting study treatment.
- Active or history of clinically significant gastrointestinal (GI) disease.
- Active or history of interstitial lung disease or Grade ≥2 pneumonitis.
- Active or history of clinically significant autoimmune disease.
- Active bleeding disorder.
- Participants who have undergone treatment with any investigational IL-12 agent.
- Active, uncontrolled infections