Ongoing camptothecin and camptothecin analogs clinical trials in June 2022

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What is camptothecin?

Alkaloid camptothecin(CPT) has shown antitumor activity in clinical trials, particularly against breast, ovarian, colon, lung, and stomach cancers.

Camptothecin was discovered by M.E.Wall and M.C.Wani in 1966 when they systematically  screened natural products for anticancer drugs.CPT is a topoisomer I inhibitor, extracted from the fruits and leaves of Camptotheca Acuminata(Happy tree), a tree native to China.

CPT has low solubility in water and ethanol, and adverse effects have been reported for direct therapeutical use. Therefore, medical chemists have developed many camptothecin analogues, and most of them are approved and used in cancer chemotherapy.

camptothecin and its derivatives clinical trials for cancers

What are the camptothecin analogues?

There are thousand Camptothecin derivatives and analogures,such as 10-hydroxycamptothecin, 7-ethyl-10-hydroxycamptothecin, Irinotecan HCl, topotecan HCl,Belotecan, exatecan, deruxtecan, Sacituzumab Govitecan,nanoparticle camptothecin, lipsome camptothecin, rubitecan,and more.

Ongoing camptothecin analogues clinical studies in June 2022.

Research and studies on camptothecin and its derivatives continues in the past 6 decades, and at least 9 clinical trials are ongoing now for camptothecin derivatives and analogues. Most of them are  made in USA and mostly are for Irinotecan, according to USA FDA.

1. A phase I/II clinical study of nanoparticle camptothecin(EP0057) with Olaparib in Patients with Relapsed/Refractory Small Cell Lung(SCLC), Bladder and Prostate Cancers.

This study is to test the safety and maximized dose of EP0057 and Olaparib together, to evaluate how well this combination treats small cell lung cancer.

Phase I: To determine phase 2 MTD/recommended dose (RP2D) of EP0057 in combination with olaparib in patients with refractory cancer.

Phase II: To determine the antitumor activity of olaparib plus EP0057 vs. with 16 weeks of progression-free survival in SCLC patients who were resistant or prone to relapse.

Expansion Cohorts: To determine the overall response rate of EP0057 plus olaparib in patients with mCRPC and urothelial carcinoma.

The program started on May 9, 2016 and is estimated to be primarily completed on July1, 2025.

2. A phase I/II study to find a safe combination of sacituzumab govitecan and berzosertib and to test if this combination will make small cell lung cancer and PARP inhibitor resistant tumors shrink.

Phase I: To determine the maximum tolerated dose (MTD) of Sacituzumab Govitecan in combination with berzosertib. participants with the HRD.
Phase II SCLC cohort: to evaluate the efficacy against ORR of the combination of sacituzumab govitecan and berzosertib in participants previously treated with SCLC.

Sacituzumab Govitecan is an anti-body drug conjugate composed of antigen 2 (Trop-2) IgG1 kappa antibody coupled to SN-38(7-ethyl-10-hydroxycamptothecin), through a proprietary hydrolyzable linker.

Berzosertib is a potent and selective ATR kinase inhibitor in Phase I and II clinical trials as a single agent and in combination with chemotherapy, radiation therapy, and other antineoplastic agents.

This study started on Sep 20, 2021 and is scheduled to reach primary completion on Mar 1, 2026.

3. A phase II trial of Trifluridine/Tipiracil in Combination With Irinotecan in treatment for Biliary Tract Cancers.

This trial is studying the effectiveness of trifluridine/tipiracil and irinotecan in the treatment of patients with cholangiocarcinoma that has spread to other sites in the body (advanced) and has not responded to treatment (tolerance). fire). Trifluridine/tipiracil and irinotecan may suppress tumor cell growth by blocking certain enzymes needed for cell growth.

The trial began on Oct18, 2019, and is primarily completed and is estimated to be finished on May 15, 2024.

4. A phase I clinical study Evaluating the Safety and Response With PF-05082566, Cetuximab, and Irinotecan in Patients With Advanced Colorectal Cancer.

This study is developing the best dose and side effects of irinotecan hydrochloride when given with utomilumab and cetuximab in the treatment of patients with colorectal cancer that has spread to other parts of the body (metastasis).

 Monoclonal antibodies, such as utomilumab and cetuximab, can interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop tumor cell growth, by killing cells, stopping them from dividing, or stopping them used utomilumab, cetuximab and irinotecan hydrochloride may be more effective in treating patients with colorectal cancer.

This study started 4 years ago on Dec 27,2017 and is planned to arrive at primary completion on Dec 31,2022.

5. The Phase I clinical trial of Intracranially Administered Carboxylesterase-Expressing Neural Stem Cells in Combination With Intravenous Irinotecan HCl in Patients With Recurrent High-Grade Gliomas.

This trial is investigating the adverse effects and best dose of allogeneic carboxylesterase-expressing neural stem cells when given with irinotecan hydrochloride in the treatment of patients with high-grade glioma who have relapsed.

Placement of genetically engineered neural stem cells into brain tumor cells may make the tumor more sensitive to irinotecan hydrochloride. Irinotecan hydrochloride can stop the growth of tumor cells by blocking certain enzymes needed for cell growth.

The clinical study is planned to last 7 years, started on Mar7,2016, and is estimated to complete primarily on Jun30, 2023. The latest update is on Jun7,2022.

6. A clinical trial on Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treatment for Metastatic Solid Tumors or solid tumors that Cannot Be Removed by Surgery.

Last updated on Feb 10, 2022, this trial evaluates the side effects and best dose of vemurafenib when applied together with cetuximab and irinotecan HCl in treating solid tumors that have spread to other sites of the body or can not be removed by surgery.

The phase I trial started on Feb 15,2013 and is estimated to complete primarily on Mar 31,2024

7. A Clinical Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan HCl (CETIRI) in Advanced/Metastatic Colorectal Cancer (mCRC) With HER-2 amplified colorectal cancer.

This randomized phase II study is to test how well the two combinations work and make a comparasion of the efficacy in treating patients with HER2/neu amplified colorectal cancer that has spread to other places in the body and cannot be removed by surgery.

The study started on Oct 9,2017 and is estimated to arrive primary completion on Nov1,2022.

8. A phase III clinical study in vigil immunotherapy in combination with Irinotecan and temozolomide in treating Ewing’s Sacoma.

Participants who undergo standard surgery (eg, tumor biopsy or palliative excision) may have tumor tissue removed to produce the study product, Vigil. Hematologic function, liver enzymes, renal function and electrolytes will be monitored.

This study started on Aug 21,2018 and is estimated to complete primarily at the end of this year.

9. A study to compare the Irinotecan liposome injection manufactured at two facilities in the adult patients with advanced cancer in Pancreas.

The responsible party for this phase I study is Ipsen and the study is estimated starting in the last month. The estimated primary completion is to be in July 2023.

Check other clinical trials for related natural extracts in the following.

1.Clinical trials data originated from US FDA.

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