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Anti-tumor antibiotic
ACTM-838 for Cancer
Phase 1
Recruiting
Research Sponsored by Actym Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Advanced solid tumor for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit, or they must be ineligible to receive or refuse to receive such therapy
Eastern Cooperative Oncology Group (ECOG) 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called ACTM-838 in patients with advanced solid tumors that have not responded to standard treatments. The study will be done in two parts: Part 1a will
Who is the study for?
This trial is for adults with advanced solid tumors that no longer respond to standard treatments. Participants must be in good physical condition (ECOG 0-1), have a CD4 count over 500/mL, at least one tumor visible on CT or MRI scans that can be biopsied, and their blood, liver, and heart functions should meet specific medical standards.
What is being tested?
ACTM-838 is being tested in this study. The first part of the trial will find the right dose of ACTM-838. Once the dose is determined, more people will join the second part to see how well it works at that dose against various solid tumors.
What are the potential side effects?
As this is a first-in-human study for ACTM-838, side effects are not yet fully known but may include typical reactions seen with cancer treatments such as fatigue, nausea, inflammation at injection sites and potential impacts on blood counts or organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an advanced cancer with no standard treatment options left.
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I am fully active or can carry out light work.
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I have a tumor that can be measured and biopsied, visible on CT or MRI scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ACTM-838 MonotherapyExperimental Treatment1 Intervention
Escalating doses of ACTM-838 in Part 1a followed by expansion in Part 1b at the recommended dose determined in Part 1a
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Who is running the clinical trial?
Actym Therapeutics, Inc.Lead Sponsor
SVP, Clinical Development, MD, PhDStudy DirectorActym Therapeutics, Inc.