Drugs / CUSP06
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06234423 | Feb 2024 → May 2027 expected | ovarian cancer | OnCusp Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-06-02 | OnCusp Therapeutics, Inc. | Results OnCusp Therapeutics Announces Encouraging Initial Phase 1a Results from Ongoing First-in-Human Study Evaluating its CDH6-Directed Antibody-Drug Conjugate, CUSP06, in Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors at the 2025 ASCO Annual Meeting oncusptx.com ↗
Promising signs of efficacy were observed in patients with heavily pretreated platinum-resistant high-grade serous ovarian cancer (HGSOC) without CDH6 pre-selection |
| 2025-02-12 | OnCusp Therapeutics, Inc. | Regulatory OnCusp Therapeutics Receives FDA Fast Track Designation for CUSP06 for the Treatment of Platinum-Resistant Ovarian Cancer oncusptx.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CUSP06, a Cadherin-6 targeting Antibody-Drug Conjugate (CDH6 ADC) and the company’s lead program, for the treatment of patients with platinum-resistant ovarian cancer (PROC). |
| 2023-08-15 | OnCusp Therapeutics, Inc. | Regulatory OnCusp Therapeutics Receives FDA Clearance for the Phase 1 Clinical Trial of CUSP06, Targeting Ovarian Cancer and Other Advanced Solid Tumors oncusptx.com ↗
OnCusp Therapeutics, a biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide, announced today the clearance of its Investigational New Drug (IND) Application for CUSP06 by the U.S. Food and Drug Administration (FDA). |
| 2023-04-12 | OnCusp Therapeutics, Inc. | Results OnCusp Therapeutics Showcases Potent Anti-Tumor Activity of its CDH6 ADC at AACR Annual Meeting 2023 oncusptx.com ↗
We are very excited to present data highlighting the exciting preclinical profile of CUSP06, a differentiated, potential global second-in-class CDH6 ADC, as we pivot to become a clinical stage company this year |
| 2023-04-06 | OnCusp Therapeutics, Inc. | Results 6320 / 27 - CUSP06/AMT-707, a new CDH6-targeting antibody-drug conjugate, demonstrates potent antitumor activity in preclinical models oncusptx.com ↗
Treatment with CUSP06 resulted in tumor regression in several CDH6 positive cell line derived xenograft (CDX) models, including PA-1, OVCAR3, and 786-O. |
All press releases naming this drug 6 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CUSP06 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06234423 ↗ |
| Modality | Other / unclassified | “Antibody drug conjugate (ADC)” NCT06234423 ↗ |
| Target | CDH6 | “Cadherin-6 (CDH6)-Directed” NCT06234423 ↗ |