a study to learn about pf-07921585 alone or with other anti-cancer medicines in people with cancer

Conditions: Non Small Cell Lung Cancer; Bladder Cancer; Renal Cell Carcinoma; Melanoma; Head and Neck Cancer; Colorectal Cancer

Summary: 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.

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 criteria:
key inclusion criteria: 1. participants aged ≥18 years or older at the time of informed consent. 2. 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. 3. ecog ps 0 or 1. key exclusion criteria: 1. participants with any other active malignancy within 3 years prior to enrollment. 2. known or suspected hypersensitivity to, or severe allergic history of, human albumin or anti-pd-(l)1 therapy. 3. 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. 4. history of venous thromboembolic event \<12 weeks prior to starting study treatment. 5. active or history of clinically significant gastrointestinal (gi) disease. 6. active or history of interstitial lung disease or grade ≥2 pneumonitis. 7. active or history of clinically significant autoimmune disease. 8. active bleeding disorder. 9. participants who have undergone treatment with any investigational il-12 agent. 10. active, uncontrolled infections

Keywords: interleukin-12 mutein sasanlimab anti-pd1 antibody lung cancer