Clinical trial · Interventional
A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors
A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER
- 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 has been terminated based on a strategic evaluation within the current Pfizer oncology portfolio. This decision is not due to any safety concerns or requests from any regulatory authorities.
Summary
Brief summary (as posted)
This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-06939999 dose escalation | Drug | — | UNRESOLVED |
| PF-06939999 in combination with docetaxel | Drug | — | UNRESOLVED |
| PF-06939999 monotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Participants will receive PF-06939999 orally at escalating doses in 28 day cycles on a continuous basis
- interventionNames
- Drug: PF-06939999 dose escalation
- type
- EXPERIMENTAL
- label
- Non small cell lung cancer monotherapy
- description
- Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
- interventionNames
- Drug: PF-06939999 monotherapy
- type
- EXPERIMENTAL
- label
- Urothelial carcinoma
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic NSCLC, urothelial carcinoma or HNSCC * Progressed after at least 1 line of treatment and no more than 3 lines of treatment * At least one measurable lesion as defined by RECIST version 1.1 * ECOG Performance Status 0 or 1 * Adequate Bone Marrow Function * Adequate Renal Function * Adequate Liver Function * Resolved acute effects of any prior therapy Exclusion Criteria: * Known active uncontrolled or symptomatic CNS metastases. * Major surgery, radiation therapy, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry. * Active, uncontrolled infection, including COVID-19 * Known or suspected hypersensitivity to PF-06939999 * Inability to consume or absorb study drug
References
Publications (1)
- DERIVEDGuo C, Liao KH, Li M, Wang IM, Shaik N, Yin D. PK/PD model-informed dose selection for oncology phase I expansion: Case study based on PF-06939999, a PRMT5 inhibitor. CPT Pharmacometrics Syst Pharmacol. 2023 Nov;12(11):1619-1625. doi: 10.1002/psp4.12882. Epub 2022 Nov 16. PMID 36394153