Trial Profile
A Phase 1 Study of RGX-202-01 (Ompenaclid) , a Small Molecule Inhibitor of the Creatine Transporter SLC6a8, as a Single Agent and as Combination Therapy in Patients With Advanced Gastrointestinal Malignancies With Select Expansion Cohorts
Status:
Active, no longer recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 11 Dec 2023
Price :
$35
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At a glance
- Drugs Bevacizumab (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Irinotecan (Primary) ; Ompenaclid (Primary)
- Indications Adenocarcinoma; Biliary cancer; Colorectal cancer; Gastric cancer; Gastrointestinal cancer; Intestinal cancer; Oesophageal cancer; Pancreatic cancer; Solid tumours
- Focus Adverse reactions; First in man; Therapeutic Use
- Sponsors Inspirna
- 24 Oct 2023 Results assessing safety, PK/PD and efficacy of ompenaclid + FOLFIRI/BEV in 2L mCRC patients ( as of 28Apr2023, 35 pts), presented at the 48th European Society for Medical Oncology Congress
- 23 Oct 2023 According to an Inspirna media release, as of Sep 18, 2023, 50 patients in the dose escalation/expansion cohorts received either 2400mg twice daily (BID) of ompenaclid plus FOLFIRI/BEV (n = 27) or 3000mg BID ompenaclid plus FOLFIRI/BEV (n = 23). 39 patients were evaluable for RECIST 1.1 response if they completed at least one treatment cycle and had at least one follow-up on treatment scan.
- 23 Oct 2023 Results presented in an Inspirna media release.