drugset / Trial / NCT05868226
PRE-ISPY Phase I/II Oncology Platform Program
Phase 1/2
Recruiting
280 enrolled
QuantumLeap Healthcare Collaborative
ALX Oncology Inc. · collabJazz Pharmaceuticals · collabPfizer · collabTransCode Therapeutics · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced, incurable, or metastatic solid tumors and/or oligometastatic malignancy and/or a high risk of recurrence following prior treatment with curative intent. The overall goal is moving promising drug regimens into a larger phase II (or III) trial and in general could feed the neoadjuvant breast I-SPY 2 Trial (NCT01042379) and/or other oncology solid tumor trial in a timely manner.
Timeline
- Start
- 2023-02-15
- Primary completion
- 2030-12-30
- Completion
- 2031-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evorpacept | Protein / enzyme biologic | 20 mg/kg | Intravenous |
| Subject | Evorpacept | Protein / enzyme biologic | 30 mg/kg | Intravenous |
| Subject | Evorpacept | Protein / enzyme biologic | 45 mg/kg | Intravenous |
| Subject | TTX-MC138 | Antisense oligonucleotide | 4.8 mg/kg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |
| Subject | Tucatinib | Small molecule | 250 mg | Oral |
| Subject | Tucatinib | Small molecule | 300 mg | Oral |
| Subject | Zanidatamab | Monoclonal antibody | 20 mg/kg | Intravenous |