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TAS6417
TAS6417 is a small-molecule inhibitor of TGF-β signaling that blocks the TGF-β receptor pathway to reduce immunosuppression in the tumor microenvironment.
TAS6417 is a small-molecule inhibitor of TGF-β signaling that blocks the TGF-β receptor pathway to reduce immunosuppression in the tumor microenvironment. Used for Advanced or metastatic solid tumors (in combination with checkpoint inhibitors, Phase 3 development).
At a glance
| Generic name | TAS6417 |
|---|---|
| Also known as | Zipalertinib, CLN-081, zipalertinib |
| Sponsor | Taiho Oncology, Inc. |
| Drug class | TGF-β receptor inhibitor |
| Target | ALK5 (activin receptor-like kinase 5) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
TAS6417 selectively inhibits ALK5 (activin receptor-like kinase 5), a key component of TGF-β receptor signaling. By blocking this pathway, the drug aims to reduce TGF-β-mediated immunosuppression in tumors, thereby enhancing anti-tumor immune responses. This mechanism is being explored in combination with checkpoint inhibitors to improve anti-cancer efficacy.
Approved indications
- Advanced or metastatic solid tumors (in combination with checkpoint inhibitors, Phase 3 development)
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Anemia
Key clinical trials
- REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors) (PHASE3)
- A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation. (PHASE2)
- Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer (PHASE2)
- A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection (PHASE3)
- A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TAS6417 CI brief — competitive landscape report
- TAS6417 updates RSS · CI watch RSS
- Taiho Oncology, Inc. portfolio CI