Clinical trial · Interventional
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
A Phase 1 Dose Escalation Study Evaluating the Safety and Tolerability of PF-06804103 in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive and Negative 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 trial was terminated based on the stage in drug development and assessment of PF-06804103 relative to the leading external competition. The decision was not due to a safety concern.
Summary
Brief summary (as posted)
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-06804103 | Drug | — | UNRESOLVED |
| PF-06804103 + Palbociclib +Letrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PF-06804103
- description
- Study Treatment
- interventionNames
- Drug: PF-06804103
- type
- EXPERIMENTAL
- label
- PF-06804103+Combination Regimen
- description
- Study Treatment
- interventionNames
- Drug: PF-06804103 + Palbociclib +Letrozole
Primary outcomes (11)
- measure
- Number of Participants With Cycle 1 (21 Days) Dose-Limiting Toxicities (DLTs) in Part 1A
- timeFrame
- First cycle, Day 1 up to Day 21
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available (Part 1A only) * HER2 positive and negative breast cancer (Part 2A) * HER2 negative breast cancer (Part 1B \& Part 2B) * Performance status of 0 or 1 * Adequate bone marrow, kidney and liver function Exclusion Criteria: * Known CNS disease including, but not limited to, metastases * History of exposure to certain cumulative doses of anthracyclines * Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy * Active and clinically significant bacterial, fungal, or viral infection * Abnormal cardiac function defined by a LVEF \<50% by ECHO or MUGA * Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases
References
Publications (1)
- DERIVEDMeric-Bernstam F, Calvo E, Lee KS, Moreno V, Park YH, Rha SY, Chalasani P, Zhong W, Zhou L, Pirie-Shepherd S, Leung ACF, Curigliano G. Safety and Tolerability of a Novel Anti-HER2 Antibody-Drug Conjugate (PF-06804103) in Patients with HER2-Expressing Solid Tumors: A Phase 1 Dose-Escalation Study. Mol Cancer Ther. 2023 Oct 2;22(10):1191-1203. doi: 10.1158/1535-7163.MCT-23-0101. PMID 37420274