Drugs / Vactosertib
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT05400122 | Sep 2022 → Dec 2026 | Hodgkins lymphoma, acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic myeloid leukemia +5 | David Wald | Suspended | No outcome recorded |
| Phase 1 | NCT04258072 | Apr 2021 → Dec 2022 | pancreatic ductal adenocarcinoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT03704675 | Aug → Sep 2018 | — | MedPacto, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03074006 | Jan 2018 → Dec 2019 | myelodysplastic syndrome | MedPacto, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03143985 | Jul 2017 → Feb 2022 | plasma cell myeloma | Koen van Besien | Completed | No outcome recorded |
| Phase 1 | NCT02160106 | Jul 2014 → Jul 2018 | — | MedPacto, Inc. | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT05588648 | May 2023 → Dec 2027 expected | osteosarcoma | MedPacto, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03666832 | Jun 2019 → Dec 2022 | malignant pancreatic neoplasm | Joon Oh Park | Unknown | No outcome recorded |
| Phase 1/2 | NCT03802084 | Apr 2019 → Mar 2024 | desmoid tumor | Hyo Song Kim | Completed | No outcome recorded |
| Phase 1/2 | NCT03732274 | Feb 2019 → May 2024 | non-small cell lung carcinoma | MedPacto, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03724851 | Dec 2018 → May 2024 | colorectal cancer, gastric cancer, gastroesophageal junction adenocarcinoma | MedPacto, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03698825 | Aug 2018 → Jan 2022 | gastric cancer | MedPacto, Inc. | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT06044311 | Sep 2024 → Mar 2027 expected | esophageal adenocarcinoma, gastroesophageal junction adenocarcinoma | Melissa Lumish | Recruiting | No outcome recorded |
| Phase 2 | NCT05436990 | Feb 2023 → Mar 2025 | mucosal melanoma | Yonsei University | Terminated | No outcome recorded |
| Phase 2 | NCT04656002 | Oct 2022 → Dec 2023 | gastric adenocarcinoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT04893252 | Jun 2021 → Dec 2023 | gastric neoplasm | Hark Kyun Kim | Unknown | No outcome recorded |
| Phase 2 | NCT06219733 | Jun 2021 → May 2022 | dermoid cyst | MedPacto, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04515979 | Dec 2020 → Aug 2024 | non-small cell lung carcinoma | MedPacto, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04064190 | Dec 2019 → Dec 2023 | urothelial carcinoma | MedPacto, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04103645 | Nov 2019 → Jul 2024 | myeloproliferative neoplasm | Weill Medical College of Cornell University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03844750 | Jul 2019 → Sep 2025 | colorectal carcinoma, metastatic malignant neoplasm | Chloe Atreya, MD, PhD | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2023-04-26 | MedPacto, Inc. | Results Vactosertib in combination with KEYTRUDA® (pembrolizumab) for colorectal cancer patients reported a mOS of 15.8 months medpacto.com ↗
According to the analysis results, the mOS of 33 metastatic colorectal cancer patients who received vactosertib (300 mg BID) in combination with KEYTRUDA was 17.35 months . |
| 2023-03-21 | MedPacto, Inc. | Results MedPacto Announces Poster Presentation on Combination Treatment of Vactosertib with PRMT5 in Pancreatic Cancer at the 2023 AACR Annual Meeting medpacto.com ↗
The combination treatment group of T1-44 and Vactosertib showed significantly improved results; 60% of mice survived more than 50 days. |
| 2023-02-16 | MedPacto, Inc. | Regulatory MedPacto receives IND approval from the Ministry of Food and Drug Safety to evaluate the safety and efficacy of Vactosertib as a single agent in patients with osteosarcoma medpacto.com ↗ |
| 2023-02-15 | MedPacto, Inc. | Results The efficacy of the combination treatment of Vactosertib with PRMT5 in pancreatic cancer was published in an international journal Cell Death and Disease (IF: 8.469) medpacto.com ↗
Combination treatment of PRM5 inhibitor with Vactosertib significantly reduced tumor size and surrounding tissue invasion and significantly improved long-term survival |
| 2023-01-17 | MedPacto, Inc. | Regulatory MedPacto receives U.S. FDA Fast Track designation for vactosertib for the treatment of metastatic osteosarcoma medpacto.com ↗
On January 17, 2023, MedPacto, a genome-based drug discovery and clinical-stage biotechnology company, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to vactosertib as a monotherapy treatment for relapsed/refractory metastatic osteosarcoma. |
| 2022-12-20 | MedPacto, Inc. | Results Vactosertib research paper is published in ‘Cancers’, an international academic journal indexed in SCIE medpacto.com ↗
The research team also demonstrated that the Vactosertib combination treatment with Imatinib is more effective for tumor suppression while decreasing the survival rate of the desmoid tumor cell than monotherapy. |
| 2022-10-10 | MedPacto, Inc. | Results Once at home on palliative care, a pediatric patient with osteosarcoma enjoys an active return to school and a prolonged progression-free period while on Vactosertib monotherapy. medpacto.com ↗
Once at home on palliative care, a pediatric patient with osteosarcoma enjoys an active return to school and a prolonged progression-free period while on Vactosertib monotherapy. |
| 2022-09-15 | MedPacto, Inc. | Regulatory MedPacto, Receives Rare Pediatric Disease Designation from the U.S. FDA for osteosarcoma patients medpacto.com ↗
On September 15th, MedPacto, a genome-based drug discovery and clinical-stage biotechnology company, announced that it received a Rare Pediatric Disease Designation from the U.S. FDA for Vactosertib as a monotherapy for the treatment of relapsed/refractory metastatic osteosarcoma. |
| 2022-09-14 | MedPacto, Inc. | Results MedPacto presents interim Phase 1b clinical results for Vactosertib in combination with FOLFOX at AACR Special Conference on Pancreatic Cancer medpacto.com ↗
To be specific, the median overall survival (mOS) of the 13 patients who received vactosertib 200mg orally twice per day was 9.3 months. |
| 2022-08-19 | MedPacto, Inc. | Regulatory MedPacto receives IND approval from FDA to evaluate the safety and efficacy of Vactosertib as a single agent in patients with osteosarcoma medpacto.com ↗
On August 5th, MedPacto, a genome-based drug discovery and clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s investigational new drug (IND) application for its Vactosertib as a single agent in patients with recurrent, refractory or progressive osteosarcoma. |
| 2022-07-12 | MedPacto, Inc. | Regulatory MedPacto, announces IND submission to U.S. FDA to evaluate safety and efficacy of Vactosertib as a single agent in patients with osteosarcoma. medpacto.com ↗ |
| 2022-05-27 | MedPacto, Inc. | Results MedPacto to present the abstract about the combination study of Vactosertib in pancreatic cancer at the American Society of Clinical Oncology Annual Meeting medpacto.com ↗
a total of 16 patients with pancreatic cancer have shown significantly improved clinical outcomes, demonstrating 23.1% of objective response rate (ORR) |
| 2018-12-21 | MedPacto, Inc. | Regulatory Keytruda Combination Trial Application Approval followed by Another Approval for the Vactosertib + Durvalumab Combination Trial Application medpacto.com ↗
MedPacto announced on October 2nd that the Ministry of Food and Drug Safety (MFDS) approved the application for the phase 1b∙2a trials evaluating Vactosertib (TEW-7197) in combination with AstraZeneca’s durvalumab (product name: Imfinzi). |
All press releases naming this drug 19 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | vactosertib | “Dose Escalation and Proof-of-Concept Studies of Vactosertib (TEW-7197) Monotherapy in Patients With MDS” NCT03074006 ↗ |
| Known as | Ew-7197 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3260567 ↗ |
| Known as | TEW-7197 | “TEW-7197 (vactosertib), a TGF-β inhibitor and imatinib demonstrated synergistic effect in vitro and xenograft model.” NCT03802084 ↗8“Dose Escalation and Proof-of-Concept Studies of Vactosertib (TEW-7197) Monotherapy in Patients With MDS” NCT03074006 ↗ “Vactosertib(TEW-7197)/ Durvalumab” NCT04064190 ↗ |
| Action | Inhibit | “inhibits protein serine/threonine kinase of activin receptor-like kinase 5 (ALK5)” NCT02160106 ↗ |
| Modality | Small molecule | “orally bioavailable small molecule” NCT02160106 ↗ |
| Route | Oral | “oral administration” NCT02160106 ↗ |
| Target | TGFBR1 | “Vactosertib is an inhibitor of protein serine/threonine kinase activity of TGF-β receptor type 1 (TGFBR1; ALK5).” NCT03143985 ↗ |