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Trial Summary

This is a Phase 1/2, open-label, dose-exploration, combination/expansion study, which will start by evaluating the safety and tolerability of NTX-301, an oral DNMT1 inhibitor, as a monotherapy in patients with advanced solid tumours, who have failed treatment with available therapies known to be active for treatment of their corresponding disease. It will then explore the safety and tolerability of NTX-301 in combination with platinum-based therapy in patients with ovarian and bladder cancer. Optionally, the safety and tolerability of NTX-301 in combination with Temozolomide (TMZ) in patients with Isocitrate Dehydrogenase 1 (IDH1) mutated high-grade glioma will also be assessed.

Acronym:

SOC2103

ACTRN/NCT /ethics:

NCT04851834

Scientific title:

A Phase 1/2, Open-label, Dose-exploration and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NTX-301 Monotherapy in Advanced Solid Tumours, and in Combination With Platinum-based Chemotherapy in Advanced Ovarian & Bladder Cancer, and in Combination With Temozolomide as Adjuvant (Maintenance) Therapy in High-grade Glioma (Optional Arm)

Sponsor / Cooperative group:

Xennials Therapeutics Australia

Trial & Patient Characteristics

Cancer TypeAll cancers; Gynaecological; Bladder
Trial TypeTreatment
PhasePhase I; Phase II
Age Range18 years to 75 years
SexAll
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2021-08-25
Anticipated End Date2023-11-01

Participating Hospitals

HospitalSouthern Oncology Clinical Research Unit
Clinical Trial CoordinatorMeggan O'Riley
EmailMeggan.ORiley@socru.org.au
Phone0491 679 039
Principal Investigator-
Recruitment StatusRecruiting