Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
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 people with advanced or metastatic solid cancers
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
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
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
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