Clinical trial · Interventional
Study of 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated by the Sponsor due to business decision and not due to any safety concerns with PF-07263689. There are no changes to the risk-benefit for participants who have received PF-07263689 in the study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Cancer | Renal Cell Carcinoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-07263689 | Biological | — | UNRESOLVED |
| Sasanlimab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Monotherapy dose escalation (Part 1A)
- description
- Participants will receive PF-07263689 once a week for 4 doses
- interventionNames
- Biological: PF-07263689
- type
- EXPERIMENTAL
- label
- Combination dose escalation (Part 1B)
- description
- Participants will receive PF-07263689 intravenous (IV) once week for 4 doses in combination with sasanlimab subcutaneous (SC) once every 4 weeks
- interventionNames
- Biological: PF-07263689
- Biological: Sasanlimab
- type
- EXPERIMENTAL
- label
- Dose expansion (Part 2) - Tumor specific Arm A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available