ERASER : A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-017 Monotherapy in Patients With Advanced Solid Tumors and Hematological Malignancies

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy,Treatment | Blood / Myeloma / Lymphoma,Bowel (colorectum),Female reproductive organs,Head and neck,Lung,Stomach and upper gastrointestinal tract,Urinary systemAcute Myeloid Leukaemia,Bladder,Chronic Myelogenous Leukaemia,Colon,Colorectum,Endometrium,Head and neck,Leukaemia,Lung,Non-Small Cell Lung Cancer,Pancreas,Rectum,Thyroid

Trial Overview Read MoreRead more

This phase I trial will test how safe and tolerable a new oral cancer drug is for the treatment of patients with advanced solid cancers or cancers of the blood.
 

This trial is treating patients with advanced solid cancers or cancers of the blood.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-017 Monotherapy in Patients With Advanced Solid Tumors and Hematological Malignancies

Commercial Sponsor

Antengene Therapeutics Limited

Summary

This study will contain two groups of patients; those with solid cancers (the solid tumours groups) and those with cancers of the blood (the haematological malignancies group). Oral ATG-017 will be administered on an empty stomach once daily in the solid tumours group. In the haematological malignancies group, ATG-017 will be administered twice a day, 12 hours apart (no food or drink other than water for 2 hours prior to, and for 1 hour after study treatment administration). All doses of ATG-017 should/will be taken at approximately the same time each day. Dosing will start at 5mg per day and study treatment 'cycles' will be defined as 21 days. Once a maximum tolerated dose/recommended dose is identified, dose expansion can/will commence with the aim of further evaluating the safety, tolerability and pharmacokinetics of ATG-017.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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