Drugs / AdAPT-001
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04673942 | Mar 2021 → Dec 2026 expected | chondrosarcoma, soft tissue sarcoma | EpicentRx, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-12-05 | EpicentRx, Inc. | Regulatory EpicentRx’s Oncolytic Virus-delivered TGFβ Inhibitor, AdAPT-001, Receives FDA Fast Track Designation for Recurrent or Refractory Soft Tissue Sarcoma Treatment epicentrx.com ↗
EpicentRx announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the oncolytic adenovirus-delivered transforming growth factor beta (TGFβ) inhibitor, AdAPT-001, plus the anti-PD-1, nivolumab, or anti-PD-L1, atezolizumab, to treat recurrent or refractory advanced or metastatic soft tissue sarcoma (STS) with disease progression after at least one prior line of therapy. |
| 2024-10-28 | EpicentRx, Inc. | Results EpicentRx To Present Compelling Phase 2 Clinical Data on AdAPT-001 Plus a Checkpoint Inhibitor in PD-1/L1 Resistant Tumors at the SITC 39th Annual Meeting epicentrx.com ↗
The combination AdAPT-001 + a checkpoint inhibitor achieved high durable overall response rates and an 8 month+ PFS in patients who progressed on checkpoint inhibitors and chemotherapy |
| 2024-05-23 | EpicentRx, Inc. | Results EpicentRx Announces Oral Presentation for the Most Clinically Advanced TGF-β Ligand Trap, AdAPT-001, at the Upcoming 2024 ASCO Annual Meeting epicentrx.com ↗
This activity includes complete responses and several durable partial responses in established checkpoint inhibitor-resistant tumor types like sarcoma and triple negative breast cancer, with some patients on treatment for nearly two years. |
| 2024-04-04 | EpicentRx, Inc. | Results EpicentRx to Present Positive Phase 2a Clinical Data with its AdAPT-001 TGF-β Trap Program in Checkpoint Inhibitor Resistant Patients at the 2024 AACR Meeting epicentrx.com ↗
Importantly, data from a Phase 1/2 clinical trial demonstrate that administration of AdAPT-001 successfully converted immunologically cold tumors, such as sarcomas and triple negative breast cancer, into immunologically hot tumors. |
| 2023-06-07 | EpicentRx, Inc. | Results EpicentRx Presents Updates on its Oncology Clinical Development Programs at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting epicentrx.com ↗
The company also presented promising first-in-human data for its transforming growth factor beta (TGFβ) trap vector, AdAPT-001. |
| 2022-04-21 | EpicentRx, Inc. | Results EpicentRx “BETA-PRIME” Phase 1 Study Progresses After Demonstrating Good Safety and Tolerability epicentrx.com ↗
Based on favorable safety observations the study will transition to the next stage, enrolling additional patients at the highest evaluated dose of AdAPT-001 with treatment given every 2 weeks. |
| 2021-12-08 | EpicentRx, Inc. | Results EpicentRx Publishes Proof-of-Concept Research on AdAPT-001 epicentrx.com ↗
This confirmation of the long serum half-life of the TGF-β trap bolsters clinical confidence that even one dose of AdAPT-001 may demonstrate prolonged activity in patients. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AdAPT-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04673942 ↗ |
| Action | Inhibit | “designed to neutralize isoforms 1 and 3 of the profibrotic and immunosuppressive cytokine, TGF-β.” PMID 35950603 ↗ Aug 2022 |
| Route | Other | “AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration” NCT04673942 ↗ |