A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies

Get Involved

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies

Study Purpose

The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or metastatic malignancies. This study is seeking participants who:

- have advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, or pancreatic ductal adenocarcinoma (PDAC); - are able to provide tumor tissue samples; - have measurable disease.

All participants will receive while at the clinic PF-08046037 alone as an intravenous (IV) infusion (given directly into a vein) or with sasanlimab as a subcutaneous (SQ) injection (given under the skin) once every 3 weeks. Participants will continue to take the study drug(s) until their cancer is no longer responding or if the patient cannot safely take them. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

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

This study is seeking participants who have the following tumor types and can provide tumor tissue samples as per below. 1. Tumor types.

- Monotherapy Dose Escalation (Part 1a) and Optimization (Part 2a) cohorts.

- Advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC.

- Must have progressive disease following at least 1 prior approved systemic therapy.

- Monotherapy Dose Expansion (Part 3a) • Advanced or metastatic NSCLC or PDAC.

- Combination Safety Evaluation (Part 1b) and Dose Optimization (Part 2b) - Advanced or metastatic NSCLC or HNSCC.

- May be either a) not received prior immunotherapy for the tumor type OR b) relapse/ refractory after prior immunotherapy.

- Combination Dose Expansion (Part 3b) - Unresectable locally advanced or metastatic HNSCC or NSCLC.

- Must not have received prior systemic cytotoxic therapy in the locally advanced or metastatic setting (first-line setting) - Must be treatment naïve to any immunotherapy.

- NSCLC must have PD-L1 expression TPS >=50% - HNSCC must have PD-L1 expression CPS >=1.

2. Tissue requirement.

- Part 1 at lower doses: sufficient archival tissue collected within 12 months of enrollment for submission to central laboratory.

- Part 1 at higher doses: de novo baseline tumor biopsy or archival tissue within 12 months of enrollment.

- Part 1 backfill: de novo baseline and on-treatment tumor biopsies are required.

- Part 2 and 3: de novo baseline or archival tissue within 6 months of enrollment.

- Part 2 and 3: mandatory on-treatment tumor biopsy, if required by sponsor.

3. Measurable disease per RECIST v1.1.Participants who meet the following might not be able to participate. 1. History of Grade >=3 immune mediated AE related to prior immune modulatory therapy and required immunosuppressive therapy. 2. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. 3. History of uveitis within the preceding 6 months. 4. Clinically significant Grade >=3 neurodegenerative disease. 5. Grade 3 or higher pulmonary disease unrelated to underlying malignancy. 6. Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist

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.	NCT06974734
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	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Carcinoma, Non Small Cell Lung, Carcinoma, Pancreatic Ductal, Malignant Melanoma, Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Part 1a

PF-08046037 monotherapy dose escalation

Experimental: Part 2a

PF-08046037 monotherapy dose optimization

Experimental: Part 3a

PF-08046037 monotherapy dose expansion

Experimental: Part 1b

PF-08046037 +sasanlimab dose escalation

Experimental: Part 2b

PF-08046037 + sasanlimab dose optimization

Experimental: Part 3b

PF-08046037 + sasanlimab dose expansion

Interventions

Drug: - PF-08046037

Given into the vein (IV; intravenous)

Drug: - sasanlimab

Given under the skin (SQ; subcutaneous)

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.

START Midwest, Grand Rapids, Michigan

Status

Address

START Midwest

Grand Rapids, Michigan, 49546

Site Contact

[email protected]

1-800-718-1021