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RecruitingLast updated: 20 September 2024

NP-105: This study is investigating a new cancer treatment drug (called RX108-A) to determine whether it is safe and effective for people with locally advanced or metastatic solid cancersA Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of RX108-A Tablet in Patients with Locally Advanced or Metastatic Solid Tumors

Clinical summary

Summary

This study is recruiting people with locally advanced or metastatic solid tumours who have failed at least one standard of care therapy, or were intolerant to a standard of care therapy, or have refused such treatment.

The study will firstly enroll participants into a dose escalation study. Participants who choose to enrol in the escalation study will be assigned a specific number of tablets of RX108-A to take each day for 3 weeks, followed by a 1 week rest. Participants will be asked to keep a diary of any side effects that they experience while taking the experimental treatment, and may be asked to stop taking the tablets if they experience any severe side effects. Participants will also be asked to provide blood samples at 4 different times during their 3-week treatment cycle. New groups of participants will be enrolled to test each higher dose of the experimental treatment until the best tolerated dose is identified.

After the best tolerated dose has been identified, a new group of up to 9 participants will be enrolled for the dose expansion study. Participants who choose to enroll in the expansion study will be assigned a specific number of tablets to take each day for 3 weeks, followed by a 1 week rest. Participants in this study will be asked to keep taking the tablets for 3-week cycles for up to 7 months, and will be asked to provide blood samples at different timepoints during their first 3-week treatment cycles. 

It is hoped this research will determine the highest safe dose of RX108-A that reduces the growth of tumours in people with locally advanced or metastatic solid cancers. 

Conditions

This trial is treating patients with advanced or metastatic solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 75

Phase

I

Trial Acronym

NP-105

More information

Trial Identifiers

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Trial sponsor

NeuPharma Pty Ltd, Novotech (Australia) Pty Limited

Scientific Title

A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of RX108-A Tablet in Patients with Locally Advanced or Metastatic Solid Tumors

Eligibility

Inclusion

 

A patient will be eligible for study participation if the patient meets all of the following criteria:
1. Signed Informed Consent Form.
2. 18 years and over.
3. Patients with locally advanced or metastatic solid tumors that have failed at least one standard of care therapy or were intolerant to, or have refused such treatment, are eligible.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Life expectancy of at least 3 months.
6. Must agree to use adequate contraception (females and males).

Exclusion

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

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You are able to swallow medication by mouth.

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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