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Closed (no longer recruiting)Last updated: 2 April 2024

ERASER: 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 bloodA 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

Clinical summary

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.

Conditions

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

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

ERASER

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Antengene Therapeutics Limited

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

Eligibility

Inclusion

  1. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
  2. Aged at least 18 years.
  3. Module A: Patient must have a documented activating alteration of the RAS-MAPK pathway.
  4. Module B: Dose Escalation Phase: Patient must have a documented activating alteration of the RAS-MAPK pathway; Dose Expansion Phase: Expansion cohorts will be further defined based on information from the Dose Escalation.
  5. Histological or cytological confirmation of a solid tumour.
  6. Patient with solid tumors must have at least 1 lesion, not previously irradiated.
  7. Estimated life expectancy of minimum of 12 weeks.
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  9. Ability to swallow and retain oral medication.

Exclusion

  1. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression.
  2. Prior ATG-017 administration in the present study.
  3. Prior treatment with an ERK1/2 inhibitor.
  4. Prior major surgery within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.
  5. Patients receiving unstable or increasing doses of corticosteroids.
  6. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.
  7. Active infection including hepatitis B, and/or hepatitis C.
  8. Known history of human immunodeficiency virus (HIV) infection.

  9. Inadequate bone marrow reserve or organ function

Inclusion

  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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