Brief Title: PF-07209960 in Advanced or Metastatic Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with dose limiting toxicities (DLTs) in Dose Escalation (Part 1)

Primary Outcome 1 - Timeframe: Baseline through 28 days after first dose (Cycle 1)

Primary Outcome 2 - Measure: Number of participants with adverse events (AEs)

Primary Outcome 2 - Timeframe: Baseline through up to 2 years

Primary Outcome 3 - Measure: Number of participants with clinically significant laboratory abnormalities

Primary Outcome 3 - Timeframe: Baseline through up to 2 years

Primary Outcome 4 - Measure: Objective response rate (ORR) in the Expansion cohorts (Part 2)

Primary Outcome 4 - Timeframe: Baseline through up to 2 years or until disease progression

CONDITION

• Non-small-cell Lung Cancer
• Squamous Cell Carcinoma of the Head and Neck
• Renal Cell Carcinoma
• Urothelial Carcinoma
• Colorectal Carcinoma
• Ovarian Carcinoma

ELIGIBILITY

Inclusion Criteria:
Histological/cytological diagnosis of selected locally advanced or metastatic solid tumor

- Demonstrated radiographic progression on most recent tumor assessment imaging

- Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously irradiated

- Eastern Cooperative Oncology Group performance status 0-2 for Part 1 and 0-1 for Part 2

- Adequate hematologic, renal, liver, and coagulation functions

- LVEF ≥50% by echocardiogram or MUGA

- Resolved acute effects of any prior therapy

- Participants in Dose Expansion (Part 2) must have ≥2 prior lines of standard of care therapy

- Able to provide tumor tissue for submission to the Sponsor, including mandatory pre-treatment tumor biopsy (adequate archival tissue within the past 1 year is accepted in lieu of new biopsy) for all participants. Participants in Part 2 must also be able to undergo new (de novo) tumor biopsy at baseline (pre-treatment) and on-treatment biopsy until the Sponsor deems that an adequate number of biopsied samples have been received.
Exclusion Criteria:
Known active symptomatic brain or leptomeningeal metastases requiring steroids.

- Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ

- Major surgery or radiation therapy within 4 weeks prior to planned first dose

- Last systemic anti-cancer therapy within 4 weeks prior to planned first dose (6 weeks for mitomycin C or nitrosoureas). Participants who received anti-PD-1 therapy require an interval of 90 days prior to first dose

- Participation in other studies involving investigational drug(s) within 4 weeks prior to planned first dose

- Active and clinically significant bacterial, fungal, or viral infection; Hepatitis B or Hepatitis C infection, AIDS-related illness (HIV+ and in good immune health as defined in the protocol may be eligible)

- Active COVID-19/SARS-CoV2

- Anticoagulation with vitamin K antagonists is not allowed

- Active bleeding disorder in the past 6 months prior to first dose

- History of clinically significant severe immune mediated adverse event that was considered related to prior immune modulatory therapy and required immunosuppressive therapy (other than hormone replacement therapy)

- History of interstitial lung disease or pneumonitis

- Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant

- Pregnant or breastfeeding female participant

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

LOCATION