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RecruitingLast updated: 15 August 2023

This Phase I/II trial is investigating the appropriate dose and effectiveness of two anticancer drugs (CN1 and CN401) in adult patients with relapsed or refractory peripheral T-cell lymphomaAn Open-label, Multi-centre, Phase I/II Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies

Clinical summary

Summary

This is an non-randomised, open-label study, investigating two study drugs CN1 and CN401 and will be conducted in two parts: Phase 1 and Phase 2. Phase 1 is a dose-finding study for the assessment of dose limiting toxicities (DTLs) in patients with advanced lymphoid malignancies. Phase 1 has five different dose level cohorts. CN1 will be administered on Day 1 of each cycle (once every three weeks) via intravenous infusion for up to 12 months and CN401 will be administered via oral tablet twice daily. Dose levels will vary depending on which cohort a participant is in. Phase 2 is an expansion study evaluating the preliminary efficacy of CN1 in combination with CN401 at the RP2D in parallel patient cohorts grouped by non-Hodgkin's Lymphoma (NHL) subtype.

Conditions

This trial is treating patients with relapsed or refractory peripheral T-cell lymphoma.

Cancer

Blood Cancers Blood

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Commercial Sponsor

Curon Biopharmaceutical (Australia) Co Pty Ltd

Scientific Title

An Open-label, Multi-centre, Phase I/II Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies

Eligibility

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • 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.

Ask your doctor if this trial could be right for you.

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