Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04851834
Status:
TERMINATED
Last Update Posted:
2022-12-20
First Post:
2021-04-08
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:
Xennials Therapeutics Australia Pty Ltd
Study Overview
Official Title:
A Phase 12 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 12 open-label dose-exploration combinationexpansion 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 n25 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 33 design
Combination Dose and Disease Expansion Phase 1b-2a n60 The study will be expanded in specific subsets of patients with solid tumours and with combination therapy as follows
Arm 1 Phase 1b n20 Dose Escalation NTX-301 platinum-based doublet therapy
Arm 2 Phase 2a n40 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 n40
Arm 3 Phase 1b n20 Dose Escalation NTX-301 combination therapy with TMZ
Arm 4 Phase 2a n20 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 n60 The study will be expanded in specific subsets of patients with solid tumours and with combination therapy as follows
Arm 1 Phase 1b n20 Dose Escalation NTX-301 platinum-based doublet therapy
Arm 2 Phase 2a n40 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 n40
Arm 3 Phase 1b n20 Dose Escalation NTX-301 combination therapy with TMZ
Arm 4 Phase 2a n20 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?:
None