Drugs / 7-ethyl-10-hydroxy Camptothecin
7-ethyl-10-hydroxy Camptothecin
also known as
SN38 · NK012 · IT141 · Camptothecin, 7-ethyl-10-hydroxy- · Irinotecan related compound b · IT-141, 7-ethyl-10-hydroxycamptothecin · LE-SN38
Small molecule targets TOP1 via inhibition
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06143774 | Oct 2023 → Dec 2026 expected | neoplasm | TaiRx, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT03096340 | Mar 2017 → Aug 2018 | cancer | Intezyne Technologies, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT01238939 | Aug 2010 → Dec 2013 | colorectal cancer | Nippon Kayaku Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01238952 | Jul → Nov 2010 | triple-negative breast carcinoma | Nippon Kayaku Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00542958 | Mar 2007 → Apr 2008 | cancer | Nippon Kayaku Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00046540 | Oct 2002 → Aug 2007 | neoplasm | INSYS Therapeutics Inc | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07391813 | Mar 2026 → Dec 2028 expected | small cell lung carcinoma | SN BioScience | Recruiting | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06986811 | May 2025 → May 2029 expected | childhood neoplasm | CEBIOTEX | Recruiting | No outcome recorded |
| Phase 2 | NCT00951613 | Jul 2009 → Jan 2012 | small cell lung carcinoma | Nippon Kayaku Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00951054 | Feb 2009 → Dec 2014 | triple-negative breast carcinoma | Nippon Kayaku Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00311610 | Jan 2006 → Jan 2007 | colorectal cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00104754 | — | small cell lung carcinoma | Alliance for Clinical Trials in Oncology | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2026-04-23 | CEBIOTEX | Results First-in-human study of CEB-01 in retroperitoneal sarcoma cebiotex.com ↗
We are proud to announce the publication of our latest clinical results in Annals of surgical oncology, detailing the first-in-human study of CEB-01, a novel biodegradable membrane for the local delivery of SN-38 after tumour resection. |
| 2024-11-21 | Starpharma Pty Ltd | Results DEP SN38 Results Showcased at GI Cancer Conference starpharma.com ↗
DEP® SN38 demonstrated promising efficacy, with sustained and durable disease control for up to 72 weeks in patients previously treated with irinotecan. |
| 2024-11-17 | Starpharma Pty Ltd | Results Bell Potter Healthcare Conference Presentation starpharma.com ↗
DEP® SN38 Phase II Study Shows Favourable Efficacy and Tolerability Data in Late-Stage Patients |
| 2024-10-30 | Processa Pharmaceuticals | Results Processa Pharmaceuticals Reports Third Quarter Business Highlights and Financial Results processapharmaceuticals.com ↗
Positive data from preclinical studies support NGC-Iri’s ability to deliver more SN-38 to tumors compared with either irinotecan or Onivyde ® |
| 2024-10-29 | Starpharma Pty Ltd | Results Australian Microcap Conference Presentation starpharma.com ↗
DEP® SN38 Phase II Study Shows Favourable Efficacy Data in Late-Stage Patients |
| 2024-06-04 | Starpharma Pty Ltd | Results DEP irinotecan presentation at ASCO 2024 Annual Meeting starpharma.com ↗
The presentation was part of a rapid oral abstract session and highlighted the final results of the DEP® irinotecan Phase 1/2 clinical trial, which were reported in full last week. |
| 2024-05-27 | Starpharma Pty Ltd | Results Positive final DEP irinotecan Phase 2 clinical trial results starpharma.com ↗ |
| 2024-05-24 | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Results 抗Trop2抗体偶联SN38用于治疗三阴性乳腺癌I期临床研究数据结果于ASCO发表 fd-zj.com ↗
根据该药物单药治疗的临床数据显示， 在接受了 10.0 mg/kg 剂量治疗且疗效可评估的 29 例 TNBC 患者中，客观缓解率（ ORR ）和疾病控制率（ DCR ）分别为 37.9% 和 79.3% 。 |
| 2024-03-21 | Scandion Oncology A/S | Results Scandion Oncology reports promising updated Phase II CORIST data, including topline overall survival scandiononcology.com ↗
The optimized dosing schedules resulted in the expected changes in PK and data demonstrated a slight decrease (app. 20%) in the maximum peak value (Cmax) of the active chemotherapy (SN-38) and an increase in the maximum peak value of SCO-101. |
| 2023-10-16 | Starpharma Pty Ltd | Results DEP irinotecan IO/PARP combination data presented at AACR starpharma.com ↗
An SN38 dendrimer nanoparticle, DEP® irinotecan (SN38-SPL9111), demonstrates efficacy in mouse models of gastrointestinal cancer and augments anti-tumor effects of immune checkpoint blockade and PARP inhibition |
| 2023-10-15 | Starpharma Pty Ltd | Results DEP irinotecan clinical data presented at AACR meeting starpharma.com ↗
The poster also includes new positive data for DEP® irinotecan in the platinum-resistant ovarian cancer patient cohort, where the objective response rate ( ORR2) in patients dosed every 2 weeks (Q2W) has increased from the previously reported 29%1 to 43%. |
| 2023-09-26 | Starpharma Pty Ltd | Results DEP irinotecan combination data presentation starpharma.com ↗ |
| 2023-09-12 | Starpharma Pty Ltd | Results Positive DEP irinotecan clinical results presentation starpharma.com ↗
In summary, DEP® irinotecan demonstrated durable anti-tumour responses in advanced CRC and platinum-resistant/refractory ovarian cancer and was very well tolerated. |
| 2023-06-23 | Starpharma Pty Ltd | Results Life Sciences Investor Forum Presentation starpharma.com ↗
Encouraging efficacy signals across multiple tumour types enhancing market potential |
| 2023-06-22 | Starpharma Pty Ltd | Results Starpharma to present at Life Sciences Investor Forum starpharma.com ↗
The latest preclinical results for Starpharma’s HER2-targeted DEP® antibody-drug conjugate (ADC), which utilised the active metabolite of irinotecan, SN-38, showed significantly greater anti-tumour activity and improved survival compared to the marketed ADC, Enhertu®, in a HER2+ human cancer xenograft model. |
| 2023-04-26 | Starpharma Pty Ltd | Results HER2-targeted DEP SN38 ADC outperforms in HER2 cancer model starpharma.com ↗ |
| 2020-06-28 | Starpharma Pty Ltd | Results DEP irinotecan boosts immuno-oncology in colon cancer models starpharma.com ↗ |
| 2020-05-06 | Starpharma Pty Ltd | Results DEP irinotecan phase 2 commences after positive phase 1 starpharma.com ↗
The trial met its objective of evaluating safety, tolerability, pharmacokinetics and preliminary efficacy data, and identifying a recommended phase 2 dose. |
| 2019-09-11 | Starpharma Pty Ltd | Results DEP irinotecan synergistic with Lynparza in refractory model starpharma.com ↗
The combination of DEP® irinotecan and Lynparza® (olaparib) provided significantly enhanced and synergistic anti-tumour efficacy compared to either drug alone, and compared to the combination of Lynparza® (olaparib) with the standard form of irinotecan. |
| 2019-05-23 | Starpharma Pty Ltd | Results DEP irinotecan combination outperforms in colon cancel model starpharma.com ↗ |
| 2018-11-13 | Ascelia Pharma AB | Results Encouraging results from clinical Phase I study of Oncoral presented in a new publication ascelia.com ↗
The interpatient variability of the active metabolite, SN-38, was in the same range as after infusion of irinotecan |
| 2018-10-23 | Ascelia Pharma AB | Results Oncoral demonstrates encouraging results in clinical phase I ascelia.com ↗
The active metabolite, SN-38, interpatient variability was in the same range as after infusion of irinotecan |
| 2017-06-05 | Starpharma Pty Ltd | Results DEP irinotecan outperforms irinotecan in cancer models starpharma.com ↗
Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its proprietary DEP® irinotecan has demonstrated significantly better anti-tumour activity and increased survival compared with irinotecan in a variety of human colon cancer models. |
| 2014-11-03 | Hanmi Pharmaceutical Company Limited | Results Hanmi pharmaceuticals and collaborative partner Kinex pharmaceuticals announce preliminary results from a Phase I clinical study (HM-OTE-103) with Oratecan？？ in patients with advanced cancer hanmipharm.com ↗
Pharmacokinetic analysis during this study indicated that exposure to Irinotecan and its active metabolite SN38 (administered orally as Oratecan) increased proportionately with dose. |
| 2008-05-16 | Nektar Therapeutics | Results Significant Anti-Tumor Activity of NKTR-102 in Patients With Refractory Solid Tumors; Interim Data Published in ASCO 2008 Proceedings nektar.com ↗
The study also demonstrates that Nektar's small molecule PEGylation technology produced an increase in SN38 exposure that was up to six-fold higher than the exposure previously reported with irinotecan at equivalent doses. |
All press releases naming this drug 26 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 7-ethyl-10-hydroxy Camptothecin | “7-ethyl-10-hydroxy Camptothecin (SN-38) formulated as a biocompatible polymeric nanofiber membrane (CEB-01)” NCT06986811 ↗ |
| Known as | Camptothecin, 7-ethyl-10-hydroxy- | ChEMBL registry synonym — accepted as the source's own label CHEMBL837 ↗ |
| Known as | Irinotecan related compound b | ChEMBL registry synonym — accepted as the source's own label CHEMBL837 ↗ |
| Known as | IT-141, 7-ethyl-10-hydroxycamptothecin | “IT-141, 7-ethyl-10-hydroxycamptothecin” NCT03096340 ↗ |
| Known as | IT141 | “IT141 is a novel nanoparticle formulation of SN-38, the active metabolite of irinotecan, and is intended to deliver more drug to the tumor with reduced toxicity on normal tissues.” NCT03096340 ↗ |
| Known as | LE-SN38 | “Liposome Encapsulated SN38 (LE-SN38) is an oncology drug product consisting of the active metabolite of irinotecan (CPT-11), a known anticancer drug, encapsulated in a liposome.” NCT00046540 ↗ |
| Known as | NK012 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01238939 ↗ |
| Known as | SN38 | “The study drug TRX-920 Oral Gel contains SN38, an active metabolite of Irinotecan (CPT-11), which is a widely prescribed anti-cancer drug that has been approved in many...” NCT06143774 ↗5“The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent.” NCT06986811 ↗ “SNB-101 is a nanoparticle formulation of SN-38 administered intravenously.” NCT07391813 ↗ |
| Action | Inhibit | “DNA topoisomerase I inhibitor” CHEMBL837 ↗ |
| Modality | Other / unclassified | “novel nanoparticle formulation of SN-38” NCT03096340 ↗ |
| Modality | Small molecule | — CHEMBL837 ↗ |
| Route | Intravenous | “LE-SN38 will be infused intravenously every 3 weeks” NCT00046540 ↗ |
| Target | TOP1 | “DNA topoisomerase I inhibitor” CHEMBL837 ↗ |