Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This trial will be conducted across two parts.
In the first part (Dose Escalation), participants will receive multiple doses of PMR-116 (administered orally), to be taken at set times throughout a 28-day treatment cycle. If this appears safe, additional participants in a second cohort will receive an increased dose of PMR-116 to be taken at set times throughout a 28-day cycle. Up to 5 increasing doses will be investigated in separate treatment cohorts until the maximum safe dose has been determined.
In the second part of the study (Dose Expansion), a new cohort of participants will receive multiple doses of the maximum safe dose of PMR-116 to be taken at set times throughout a 28-day cycle. Participants in each part of the study will be asked to provide a sample of their tumour (taken via a biopsy) prior to starting PMR-116, and those in the second part will also be asked to provide a sample after 22 days after starting treatment. It is hoped this research will determine the maximum dose of PMR-116 that can be administered safely without causing severe reactions. Once the dose of PMR-116 has been determined, a larger trial investigating the efficacy of PMR-116 as a treatment for cancer patients with advanced solid tumours may proceed.
Conditions
This trial is treating people with advanced solid cancers
Eligibility
Inclusion
• Ability to understand and be willing to sign an informed consent form.
• MYC positive, histopathologically confirmed, locally advanced or metastatic cancer (solid tumour) for which all available standard of care treatment options has been exhausted or refused and for which at least one lesion is measurable.
• Most recent chemotherapy treatment at least 3 weeks, or monoclonal antibody treatment at least 4 weeks, or allogeneic stem cell transplantation at least 24 weeks or radiation therapy at least 3 weeks prior to starting treatment with PMR-116.
• Males and females aged over 18 years
• Eastern Cooperative Oncology Group (ECOG) status of 0 to 1
• Adequate liver and renal function as evidenced by pathology test results
• No recent major surgery at least 4 weeks prior to starting treatment with PMR-116
• Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.
• Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion.
• Be willing to use protective measures against sun exposure and avoid the use of tanning salons and tanning beds
• Have an estimated life expectancy of at least 3 months.
• Dose Expansion only: Have a site of disease amenable to biopsy and be willing to undergo a biopsy prior to and during treatment with PMR-116
Exclusion
• Receiving any concurrent anti-cancer therapy
• Adverse Events from prior treatments which have not recovered to at least a mild (Grade 1) severity
• Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable with no CNS surgery or radiotherapy within 28 days prior to the first dose of PMR-116
• Any uncontrolled illness that would limit compliance with study requirements
• Any uncontrolled infection
• Known Human Immunodeficiency Virus (HIV) infection
• Active hepatitis B or hepatitis C infection
• Pregnant or breast feeding
• Unable to swallow oral medications
• Gastrointestinal conditions that could affect absorption of PMR-116
• Evidence of abnormal cardiac function
• Prior treatment with an RNA polymerase I inhibitor
Inclusion
- You are able to swallow medication by mouth.
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
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 ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Pimera Australia Pty Ltd
Scientific Title
Investigating the safety and tolerability of PMR-116 in Patients with Advanced Malignancies
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