Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 10:52 AM
Study NCT ID:
NCT04851834
Status:
TERMINATED
Last Update Posted:
2022-12-20
First Post:
2021-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NTX-301 Monotherapy in Advanced Solid Tumours and in Combination With Platinum-based Chemotherapy in Advanced Ovarian & Bladder Cancer and in Combination With Temozolomide in High-grade Glioma
Sponsor:
Xennials Therapeutics Australia Pty Ltd
Organization:
Study Overview
Official 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)
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated by IP Holder (collaborator), PinotBio Inc.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Dose Exploration (Phase 1a, n\~25): This part of the study will assess the safety and tolerability of NTX-301 and to identify the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). It will initiate with a dose escalation using a 3+3 design.
Combination Dose and Disease Expansion (Phase 1b-2a, n\~60): The study will be expanded in specific subsets of patients with solid tumours and with combination therapy as follows:
* Arm 1 (Phase 1b, n\~20): Dose Escalation, NTX-301 platinum-based doublet therapy
* Arm 2 (Phase 2a, n\~40): Dose Expansion, NTX-301 platinum-based doublet therapy
Patients with advanced ovarian \& bladder cancer considered to be incurable by the investigator and for which available anti-cancer therapy has been exhausted will be enrolled for this component. Patients will be given NTX-301 at the MTD determined in Phase 1a. This will be combined with a platinum-based agent that will be administered by IV infusion.
Optional Cohort -High-Grade Glioma Combination Dose \& Disease Expansion (Phase 1b-2a, n\~40)
* Arm 3 (Phase 1b, n\~20): Dose Escalation, NTX-301 combination therapy with TMZ
* Arm 4 (Phase 2a, n\~20): Dose Expansion, NTX-301 combination therapy with TMZ
Patients with IDH1 mutated high-grade glioma that have commenced initial chemoradiotherapy with temozolomide and are yet to commence Temozolomide maintenance therapy will be enrolled for this component. Patients will be given NTX-301 at the MTD determined in Phase 1a. This will be combined with TMZ that will be administered orally.
Combination Dose and Disease Expansion (Phase 1b-2a, n\~60): The study will be expanded in specific subsets of patients with solid tumours and with combination therapy as follows:
* Arm 1 (Phase 1b, n\~20): Dose Escalation, NTX-301 platinum-based doublet therapy
* Arm 2 (Phase 2a, n\~40): Dose Expansion, NTX-301 platinum-based doublet therapy
Patients with advanced ovarian \& bladder cancer considered to be incurable by the investigator and for which available anti-cancer therapy has been exhausted will be enrolled for this component. Patients will be given NTX-301 at the MTD determined in Phase 1a. This will be combined with a platinum-based agent that will be administered by IV infusion.
Optional Cohort -High-Grade Glioma Combination Dose \& Disease Expansion (Phase 1b-2a, n\~40)
* Arm 3 (Phase 1b, n\~20): Dose Escalation, NTX-301 combination therapy with TMZ
* Arm 4 (Phase 2a, n\~20): Dose Expansion, NTX-301 combination therapy with TMZ
Patients with IDH1 mutated high-grade glioma that have commenced initial chemoradiotherapy with temozolomide and are yet to commence Temozolomide maintenance therapy will be enrolled for this component. Patients will be given NTX-301 at the MTD determined in Phase 1a. This will be combined with TMZ that will be administered orally.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: