idetrexed (CT900) / Carrick Therap, Boston Scientific, Algok Bio - LARVOL DELTA

IDOL: Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Institute of Cancer Research, United Kingdom | Not yet recruiting ➔ Recruiting | Initiation date: May 2025 ➔ Aug 2025

Enrollment open • Trial initiation date • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

IDOL: Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Institute of Cancer Research, United Kingdom

New P1 trial • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

Ovarian cancer drug to enter phase II clinical trial (Medical Xpress) - "The phase II trial will further test idetrexed's effectiveness and safety in a larger group of patients, specifically with ovarian cancer. Idetrexed is set to undergo the larger trial thanks to a new agreement between US-based pharmaceutical company Algok Bio and BTG International, which partnered with the ICR earlier in the drug's development....Algok Bio will soon initiate pivotal studies for registering idetrexed for ovarian cancer treatment."

New P2 trial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Algok Bio Enters into Exclusive Worldwide License Agreement with BTG to Develop and Commercialize Idetrexed, a Clinical-Stage Folate Receptor-Targeted Oncology Drug (BioPharma Dive) - "Algok Bio Inc...has announced that it has secured an exclusive worldwide license agreement with global healthcare company BTG International Ltd. (BTG) for the development and commercialization of idetrexed, a clinical-stage targeted oncology drug for ovarian cancer that is heading into Phase II development....Algok Bio's exclusive license agreement with BTG grants the former the rights to develop and commercialize idetrexed worldwide. Under the agreement, Algok Bio will make an upfront payment to BTG and additional payments contingent on achieving specific regulatory and sales milestones, as well as tiered royalty payments. Algok Bio will soon initiate pivotal studies for registering idetrexed for ovarian cancer treatment."

Licensing / partnership • Gynecologic Cancers • Oncology • Ovarian Cancer

An investigator-initiated phase I study of ONX-0801, a first-in-class alpha folate receptor targeted, small molecule thymidylate synthase inhibitor in solid tumors. (ASCO 2017) - P1; "The RP2D of ONX-0801 is 12 mg/m2 Q2W. At the RP2D, multiple patients with AFR overexpressing HGSOC have had PRs and further randomized biomarker prespecified phase II trials are warranted."

P1 data • Biosimilar • Immunology • Ovarian Cancer

A phase I trial of CT900, a novel α-folate receptor-mediated thymidylate synthase inhibitor, with expansion cohorts in patients with high grade serous ovarian cancer. (PubMed, Clin Cancer Res) - "The dose of 12 mg/m2/q2Wk was declared the recommended phase II dose/schedule. At this dose/schedule, CT900 exhibited an acceptable side effect profile with clinical benefit in patients with high/medium α‑FR expression and warrants further investigation."

Journal • P1 data • Cough • Fatigue • Hematological Disorders • Inflammation • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pneumonia • Respiratory Diseases • Solid Tumor

[VIRTUAL] A phase I trial a FR alpha targeted thymidylate synthase inhibitor CT900 exploring four schedules of treatment in expansion cohorts of patients with high-grade serous ovarian cancer. (ASCO 2020) - P1 | "Background: CT900 (BTG945/ONX-0801) is a novel small molecule that binds to folate receptor alpha (FRα), is internalized and causes cytotoxicity by thymidylate synthase inhibition...Four expansion cohorts were studied which included: schedule A (6 mg/m2/q every 2 weeks), schedule B (12 mg/m2/q every 2 weeks), schedule C (12 mg/m2/q every 2 weeks with 12 mg dexamethasone IV and 8 mg of dexamethasone for 2 days) and schedule D (12 mg/m2/q every 3 weeks)... CT900 has shown clinical activity in patients with heavily pre-treated platinum-resistant, high/medium FRα expressing HGSOC. Based on toxicity and efficacy, the schedule of 12 mg/m2/q2 weekly (schedule B) is the recommended phase II dose for further evaluation in patients with relapsed high/medium FRα expressing HGSOC. Research Funding: Carrick Therapeutics;BTG; Onyx"

Clinical • P1 data • Fatigue • Gynecologic Cancers • Hematological Disorders • Immunology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pneumonia • Solid Tumor • CA125 • FOLR1

Phase I Trial of ONX-0801 Once Weekly or Alternate Weekly (clinicaltrials.gov) - P1; N=111; Completed; Sponsor: Royal Marsden NHS Foundation Trust; Active, not recruiting ➔ Completed; N=66 ➔ 111; Trial completion date: Aug 2021 ➔ Mar 2021

Clinical • Enrollment change • Trial completion • Trial completion date • Endometrial Cancer • Hodgkin Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

Phase I Trial of ONX-0801 Once Weekly or Alternate Weekly (clinicaltrials.gov) - P1; N=66; Active, not recruiting; Sponsor: Royal Marsden NHS Foundation Trust; Trial completion date: Aug 2020 ➔ Aug 2021; Trial primary completion date: Aug 2020 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Endometrial Cancer • Hematological Malignancies • Hodgkin Lymphoma • Oncology • Solid Tumor

The contribution of serum cortisone and glucocorticoid metabolites to detrimental bone health in patients receiving hydrocortisone therapy. (PubMed, BMC Endocr Disord) - P4 | "Serum cortisol and cortisone and total urinary corticosteroid metabolites are negatively associated with bone turnover markers in patients receiving replacement doses of hydrocortisone, with nocturnal glucocorticoid exposure having a potentially greater influence on bone turnover."

Clinical • Journal • Endocrine Disorders • Nephrology • Osteoporosis • Renal Disease • Rheumatology

Phase I Trial of ONX-0801 Once Weekly or Alternate Weekly (clinicaltrials.gov) - P1; N=66; Active, not recruiting; Sponsor: Royal Marsden NHS Foundation Trust; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2016 ➔ Aug 2020; Trial primary completion date: Dec 2015 ➔ Aug 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date