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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

NCT04851834 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-12-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

NTX-301

Oral hypomethylating agent

DRUG

Platinum-based Chemotherapy

Standard of care for ovarian and bladder cancer

DRUG

Temozolomide

Standard of care for high-grade glioma

Sponsors & Collaborators

  • Pinotbio, Inc.

    collaborator INDUSTRY

  • Xennials Therapeutics Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Joyce L. Steinberg, MD · Xennials Therapeutics Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2022-11-08
Completion
2022-11-08
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04851834 on ClinicalTrials.gov