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: OBIR-2
  • NTC ID: NCT05061537
  • Sponsor: Pfizer
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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
    Recruiting
  • Start Date
    October 20, 2021
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with dose limiting toxicities (DLTs) in Dose escalation (Part 1A and 1B)

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

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

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 90 days after first dose

Primary Outcome 4 - Measure: Objective response rate in the dose expansion (Part 2) arms

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

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: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

LOCATION

Facility Status Contact
Facility: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: N/A