drugset / Trial / NCT04632992
A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase II, multicenter, non-randomized, open-label, multi-arm study designed to evaluate the safety and efficacy of targeted therapies as single agents or in rational, specified combinations in participants with advanced unresectable or metastatic solid tumors determined to harbor specific biomarkers. Patients will be enrolled based on local testing performed at a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory. The multi-arm structure of the MyTACTIC study allows patients with solid tumors to be treated with a drug or drug regimen tailored to their biomarker identified at screening.
Timeline
- Start
- 2021-01-13
- Primary completion
- 2023-12-04
- Completion
- 2024-02-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alectinib | Small molecule | 600 mg | Oral |
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Docetaxel | Small molecule | — | — |
| Subject | Entrectinib | Small molecule | 600 mg | Oral |
| Subject | Inavolisib | Small molecule | 9 mg | Oral |
| Subject | Ipatasertib | Small molecule | 400 mg | Oral |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf | Unknown | 600 mg | Subcutaneous |
| Subject | Pralsetinib | Small molecule | 400 mg | Oral |
| Subject | Tiragolumab | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | Intravenous |
| Subject | Tucatinib | Small molecule | 300 mg | Oral |