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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 more

Other outcome measures

Pharmacodynamic activity of IMX-110 with appropriate biomarkers.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Imx-110Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Immix Biopharma Australia Pty LtdLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available for participants of this experiment?

"Affirmative. Clinicaltrials.gov reveals that, since its initial posting on February 15th 2018, this medical study is still enrolling participants from two different sites and seeking 70 individuals in total."

Answered by AI

What is the current number of participants in this research endeavor?

"Accurately, clinicaltrials.gov reveals this ongoing research which was initially published on February 15th 2018 is actively searching for participants. Approximately 70 people need to be recruited from two distinct medical centres."

Answered by AI

What key goals are this trial attempting to achieve?

"The primary metric evaluated over a 28-day timeframe is the number of patients with treatment-related adverse effects as per CTCAE v4.03 criteria. Secondary goals include measuring Duration of Response (DOR) via RECIST version 1.1, Overall Survival (OS), and Plasma concentrations for IMX-110 at predetermined intervals across Cycle 1 Day 1 and 5."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IMX-110 in Patients With Advanced Solid Tumors

2018. "IMX-110 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03382340.