A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers

Study Purpose

The purpose of this study is to learn about the effects of a new study medicine called PF-08046032, when taken alone and when taken with another medicine called sasanlimab, for the treatment of advanced cancers. The effects are studied in adult participants with certain types of lymphomas or solid tumors that are advanced or metastatic (spread to other parts of the body). The study has three parts:

- Part A will test PF-08046032 alone at increasing dose levels in participants with certain lymphomas (cancer that begins in cells of the immune system) and in participants with certain solid tumors whose disease has worsened on or after standard treatments.

- Part B will test PF-08046032 (at selected doses) and sasanlimab in participants with certain solid tumors, including those whose disease has worsened on or after standard treatments as well as participants before receiving standard treatments.

- Part C will further test the combination of PF-08046032 and sasanlimab in participants with specific types of solid tumors based on the results from Part A and Part B of the study.

All participants will receive the study drug PF-08046032. Only participants in Part B and Part C of the study will also receive sasanlimab. PF-08046032 will be given as an intravenous (IV) infusion, which means it will be injected directly into a vein. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

INCLUSION CRITERIA:

1. Histological or cytological diagnosis of metastatic or unresectable malignancy:

- Part A1: Participants with lymphomas (cHL, PTCL, large B-cell lymphoma) who have progressed on/after standard therapies.

- Part A2: Participants with solid tumors (NSCLC, HNSCC, melanoma, or other limited tumor types) who have progressed on or following prior immune checkpoint inhibitor if indicated and available.

- Part B: Participants with solid tumors who have either progressed on/after prior immune checkpoint inhibitor, or who have not received prior immune checkpoint inhibitor therapy.

- Part C: Participants with selected tumor type who have not received systemic anticancer treatment for the tumor type (including prior immune checkpoint inhibitor.

2. Measurable disease as defined by Lugano Classification for lymphomas or RECIST 1.1 for solid tumors. 3. Able to provide tumor tissue(s) as defined by the protocol depending on the Part of the study at enrollment. 4. ECOG Performance Status score 0 or 1.

EXCLUSION CRITERIA:

1. Ongoing peripheral neuropathy. 2. History of significant immune-mediated adverse event considered related to prior immune-modulatory therapy. 3. Known or suspected active autoimmune disease

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06870487
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peripheral T Cell Lymphoma, Diffuse Large B-cell Lymphoma, Classical Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma, Melanoma, Non-Small Cell Lung Cancer
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: PF-08046032 Monotherapy Dose Escalation

PF-08046032 will be given as an intravenous (IV) infusion.

Experimental: PF-08046032 + Sasanlimab Combination Safety Evaluation

PF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection.

Experimental: PF-08046032 + Sasanlimab Combination Expansion Cohort

PF-08046032 will be given as an intravenous (IV) infusion and sasanlimab will be administered as a subcutaneous injection.

Interventions

Drug: - PF-08046032

PF-08046032 will be administered intravenously (IV) infusion.

Drug: - Sasanlimab

Sasanlimab will be administered as subcutaneous (SC) injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Highlands Oncology Group, PA, Fayetteville 4110486, Arkansas 4099753

Status

Not yet recruiting

Address

Highlands Oncology Group, PA

Fayetteville 4110486, Arkansas 4099753, 72703

Site Contact

[email protected]

1-800-718-1021

Highlands Oncology Group, PA, Rogers 4128894, Arkansas 4099753

Status

Not yet recruiting