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RecruitingLast updated: 30 November 2023

This study is testing how safe, tolerable and effective a new targeted therapy is in people with locally advanced or metastatic solid cancersA Phase 1, Open-label Study of the Safety, Pharmacokinetics and Efficacy of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors

Clinical summary

Summary

This study has two parts: Dose Escalation and Dose Expansion.

In Part 1 (Dose Escalation), participants will receive the study drug (called RX108) in ascending doses to evaluate its safety and tolerability, and termined the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). 

In Part 2 (Dose Expansion), the safety and effectiveness of RX108 will further be evaluated when it is administered at the RP2D determine in Part 1.

Conditions

This trial is treating patients with advanced or metastatic solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

NeuPharma, Inc.

Scientific Title

A Phase 1, Open-label Study of the Safety, Pharmacokinetics and Efficacy of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors

Eligibility

Inclusion

  • Histologically confirmed locally advanced or metastatic cancer that has failed all systemic therapies known to confer clinical benefit
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Minimum age of 18 years
  • Adequate hematologic, hepatic and renal function
  • Written Informed Consent
  • Must agree to use adequate contraception (females and males)

Exclusion

  • History of certain cardiac abnormalities
  • History of inadequate pulmonary function
  • Symptomatic brain metastasis
  • Treatment with prohibited medications
  • Known contra-indication to digoxin
  • Treatment with any unapproved therapies for cancer, or any other anti-cancer therapy within 3 weeks
  • Any toxicity related to prior treatment must have resolved to Grade 1 or less, with the exception of alopecia
  • Clinically significant active infection requiring systemic antibiotic treatment
  • Females who are pregnant or breastfeeding

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

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.

Participating hospitals

Recruiting hospitals

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Victorian Cancer Registry Victorian Government

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

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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.