Ovarian Cancer Clinical Trial

Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors

Summary

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy.

The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

37

Study ID:

NCT04628780

Recruitment Status:

Terminated

Sponsor:

Pfizer

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There are 6 Locations for this study

See Locations Near You

City of Hope Investigational Drug Service (IDS)
Duarte California, 91010, United States
City of Hope
Duarte California, 91010, United States
Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States
UCLA Hematology/Oncology
Los Angeles California, 90095, United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica California, 90404, United States
UCLA Hematology Oncology - Santa Monica
Santa Monica California, 90404, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville Tennessee, 37203, United States
TriStar Centennial Medical Center
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center- Investigational Pharmacy
Houston Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Christus Santa Rosa Hospital
San Antonio Texas, 78229, United States
NEXT Oncology
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

37

Study ID:

NCT04628780

Recruitment Status:

Terminated

Sponsor:


Pfizer

How clear is this clinincal trial information?

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