Clinical trial · Interventional
A Study of PF-07260437 in Advanced or Metastatic Solid Tumors
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTITUMOR ACTIVITY OF PF-07260437 IN 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): Pfizer has made an internal business decision to not continue further development of PF-07260437. This decision was not due to major safety concerns or requests from any regulatory authorities.
Summary
Brief summary (as posted)
A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| B7-H4 IHC | Diagnostic Test | — | UNRESOLVED |
| PF-07260437 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Monotherapy dose escalation (Part 1)
- description
- Participants will receive PF-07260437
- interventionNames
- Drug: PF-07260437
- type
- EXPERIMENTAL
- label
- Dose Expansion (Part 2A) - Tumor specific Arm A
- description
- Participants will receive PF-07260437
- interventionNames
- Drug: PF-07260437
- Diagnostic Test: B7-H4 IHC
- type
- EXPERIMENTAL
- label
- Dose Expansion (Part 2B) - Tumor specific Arm B
- description
- Participants will receive PF-07260437
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Part 1: Histological/cytological diagnosis of selected locally advanced or metastatic breast cancer, endometrial cancer and ovarian cancer * Part 2A:In second line or more, participants with histological/cytological diagnosis of locally advanced or metastatic HR+ HER2- breast cancer showing high B7-H4 expression * Part 2B: In second line or more participants with histological or cytological diagnosis of locally advance or metastatic HR+ Her2- breast cancer or triple negative breast cancer (TNBC) with no biomarker pre-selection * Part 2C: In second line or more participants with histological diagnosis of locally advance or metastatic triple negative breast cancer with high B7-H4 expression * Thyroid function within normal laboratory range; in participants with abnormal thyroid function if Free T4 is normal and participant is clinically euthyroid, participants is eligible Exclusion Criteria: * Participants with any active malignancy within 3 years prior to enrollment * Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including participants with massive uncontrolled effusions \[pleural, pericardial, peritoneal\], pulmonary lymphangitis, and over 50% liver involvement). * History of Grade ≥3 immune mediated adverse events (including liver function tests that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co stimulatory agents, etc.) and required immunosuppressive therapy within 1 year of treatment.
References
Publications (1)
- DERIVEDYan F, Cruz-Correa M, Specht J, Wang EW, Lu J, Soliman H, Jackson-Fisher A, Tang SY, Jiang S, Le Corre C, Li M, Sommerhalder D. A phase 1 study of PF-07260437, a B7-H4 x CD3 bispecific T-cell engager, in patients with advanced or metastatic breast, ovarian, and endometrial cancer. Invest New Drugs. 2026 Aug;44(4):305-316. doi: 10.1007/s10637-026-01614-2. Epub 2026 May 22. PMID 42171881