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OTX-2002 for Liver Cancer (MYCHELANGELO I Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Omega Therapeutics
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 through treatment completion, up to two years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, OTX-2002, for safety, tolerability, and effectiveness in treating patients with hepatocellular carcinoma and other solid tumors.
Who is the study for?
Adults over 18 with advanced liver cancer (hepatocellular carcinoma) or solid tumors linked to the MYC gene, who've tried standard treatments without success. They must have a good performance status and controlled hepatitis B if present. Those with severe liver complications, brain metastases, recent bleeding from esophageal varices, or specific types of mixed liver cancers cannot join.
What is being tested?
OTX-2002 is being tested alone and alongside standard treatments for its safety and effectiveness against certain cancers. The trial has two parts: first testing OTX-2002 by itself (monotherapy), then in combination with other cancer drugs (combination therapy).
What are the potential side effects?
Potential side effects may include typical reactions seen with cancer therapies such as nausea, fatigue, skin reactions, changes in blood counts leading to increased infection risk or bleeding tendencies, and possible organ-specific inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through treatment completion, up to two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through treatment completion, up to two years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine Dose limiting toxicities (DLT)and maximum tolerated dose ( MTD) (Part 1 escalation and Part 2 safety run-in)
Duration of Response (DOR) (for Part 1 and Part 2 expansion)
Incidence of TEAEs including all AEs,Grade 3-5 AEs, drug-related AEs, and SAEs (Part 1 escalation and Part 2 safety run-in)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: OTX-2002 + Tyrosine Kinase Inhibitor TwoExperimental Treatment2 Interventions
OTX-2002 + Tyrosine Kinase Inhibitor Two : (Cycle length = 4 weeks) OTX-2002 will be administered as an IV infusion over 80-120 minutes every 2 weeks.
Tyrosine Kinase Inhibitor Two will be standard per the respective fixed local approved dose
Group II: OTX-2002 + Tyrosine Kinase Inhibitor OneExperimental Treatment2 Interventions
OTX-2002 + Tyrosine Kinase Inhibitor One: (Cycle length = 4 weeks) OTX-2002 will be administered as an IV infusion over 80-120 minutes every 2 weeks.
Tyrosine Kinase Inhibitor One will be standard per the respective fixed local approved dose
Group III: OTX-2002 + Checkpoint InhibitorExperimental Treatment2 Interventions
OTX-2002 + Immune Checkpoint Blockade: (Cycle length = 6 weeks) OTX-2002 will be administered as an IV infusion over 80-120 minutes every 2 weeks.
Checkpoint Inhibitor will be standard per the respective fixed local approved dose
Group IV: OTX-2002Experimental Treatment1 Intervention
Monotherapy: OTX-2002 (Cycle length = 4 weeks) OTX-2002 will be administered as an IV infusion over 80-120 minutes every 2 weeks
Find a Location
Who is running the clinical trial?
Omega TherapeuticsLead Sponsor
Hao-Fei Tiffany Wang, MDStudy DirectorOmega Therapeutics
Ting-Hui Wu, MDStudy DirectorOmega Therapeutics
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to the main blood vessel of my liver.I have brain metastases or carcinomatous meningitis that hasn't been treated.My liver cancer is at an intermediate or advanced stage and cannot be treated with local therapies.I am 18 years old or older.My condition worsened or didn't improve after at least 1 treatment, and no standard treatment options are left.I have not had hepatic encephalopathy in the last 3 months.I have had bleeding from varices in my esophagus or stomach in the last 3 months.My cancer has spread into the bile duct.I have had fluid drained from my abdomen in the last 3 months.My liver cancer is a specific type called mixed cholangiocarcinoma or fibrolamellar HCC.My cancer has spread, can't be surgically removed, or has come back and doesn’t respond to standard treatments.I am fully active or restricted in physically strenuous activity but can do light work.My liver cancer affects more than half of my liver.I have chronic hepatitis B, have been on antiviral therapy for 12 weeks or more, and my HBV viral load is under 500 IU/mL.
Research Study Groups:
This trial has the following groups:- Group 1: OTX-2002 + Checkpoint Inhibitor
- Group 2: OTX-2002
- Group 3: OTX-2002 + Tyrosine Kinase Inhibitor Two
- Group 4: OTX-2002 + Tyrosine Kinase Inhibitor One
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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