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IMX-110 for Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Immix Biopharma Australia Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is designed to assess the safety and tolerability of a new drug, IMX-110, with the goal of finding the recommended dose for further study.
Who is the study for?
This trial is for adults over 18 with advanced solid tumors who have not responded to standard treatments. They should expect to live at least 3 months, be in a decent physical state (ECOG 0-2), and have good heart function and blood test results. Participants must use effective contraception and cannot join if pregnant, breastfeeding, or planning pregnancy soon.Check my eligibility
What is being tested?
IMX-110 is being tested in patients with various types of advanced solid tumors. The study has two phases: Phase 1 determines the safest dose with acceptable side effects (dose escalation) and Phase 2a tests this dose further (dose expansion).See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones may include reactions at the injection site, fatigue, nausea, changes in blood counts or liver enzymes which will be closely monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of IMX-110 in patients with advanced solid tumors for evaluation in Phase 2a.
Number of participants with treatment-related adverse events assessed by CTCAE v4.03.
Recommended Phase 2 Dose (RP2D) of IMX-110 in patients with advanced solid tumors
Secondary outcome measures
Duration of Response (DOR)
Overall Survival (OS)
Plasma concentrations of IMX-110
+2 moreOther outcome measures
Pharmacodynamic activity of IMX-110 with appropriate biomarkers.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Imx-110Experimental Treatment1 Intervention
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Who is running the clinical trial?
Immix Biopharma Australia Pty LtdLead Sponsor
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