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Brief Title: PF-07263689 in Participants With Selected Advanced Solid Tumors

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY AND PHARMACODYNAMICS OF PF-07263689, EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PREVIOUSLY TREATED PARTICIPANTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

INTRODUCTION

  • Org Study ID: C4651001
  • Secondary ID: N/A
  • NCT ID: NCT05061537
  • Sponsor: Pfizer

BRIEF SUMMARY

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and expansion study intended to evaluate the safety, viral load kinetics and shedding, pharmacodynamic, and anti-tumor activity of PF-07263689, either alone or in combination with sasanlimab (an investigational anti-programmed cell death protein 1 [PD-1] antibody), in patients with selected locally advanced or metastatic solid tumors who have exhausted all available standard of care therapies available to them.

The study consists of 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and in combination with sasanlimab (Part 1B), followed by Part 2 dose expansion for the combination therapy.

  • Overall Status
    Terminated
  • Start Date
    October 20, 2021
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Renal Cell Cancer
  • Melanoma
  • Non-Small-Cell Lung Cancer
  • Hepatocellular Cancer
  • Bladder Cancer
  • Sarcoma
  • Head and Neck Cancer
  • Colorectal Cancer
  • Ovarian Cancer
  • Squamous Cell Carcinoma

ELIGIBILITY

Inclusion Criteria:
* Histological or cytological diagnosis of locally advanced or metastatic solid tumors known to have approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents

- * Have exhausted (or refuse) all available standard of care therapy (e.g., including anti-PD1/programmed death ligand 1 [PDL1] if applicable) or for whom no standard therapy is available for their tumor type

- * Patients with prior anti-PD1/PDL1 must have documentation of primary or secondary resistance to last prior anti-PD1/PDL1 therapy according to Immunotherapy Resistance Committee (SITC) (Kluger et al, 2020)

- * Have at least 1 measurable lesion by RECIST 1.1 that has not been previously irradiated (for Part 2 only)

- * Have recently obtained archival tumor tissue sample available, or undergo de novo tumor biopsy

- * Eastern Cooperative Oncology Group (ECOG) PS 0-1

- * Adequate hematologic, renal, and liver functions

- * Dose Escalation (Part 1A and 1B): Any advanced or metastatic solid tumor fulfilling other relevant eligibility criteria.

- * Dose Expansion (Part 2): Tumor specific cohorts (NSCLC, RCC, melanoma, MSS CRC) must have received prior approved therapies (Part 2)
Exclusion Criteria:
* Other active malignancy

- * Recent major surgery

- * Systemic anticancer therapy and chemotherapy within protocol-defined washout period

- * Known or suspected hypersensitivity to prior treatment with any vaccinia oncolytic, pox virus, or antiviral agents within the past 10 years

- * Current or history of myocarditis or congestive heart failure (New York Heart Association [NYHA] III-IV); unstable angina; or serious uncontrolled arrhythmia or recent myocardial infarction

- * Active or history of interstitial lung disease (ILD)/pneumonitis

- * Patients requiring chronic systemic immunosuppressants

- * History of severe immune mediated side effect that was considered related to prior immune modulatory therapy and requiring immunosuppressive therapy

- * Known symptomatic brain metastases requiring steroids

- * History of or ongoing severe inflammatory skin conditions or severe eczema having required medical treatment

- * Any prior or planned organ transplant

- * Presence of any open, active wound requiring treatment

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: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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