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Monoclonal Antibodies
STAR0602 for Advanced Cancers (START-001 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Marengo Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Phase 1, participants must have high mutational burden (TMB-H), microsatellite instability (MSI-H)/DNA mismatch repair (dMMR), or virally associated tumors.
Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
START-001 Trial Summary
This trial tests a new drug to treat advanced solid tumors. It looks at safety and how well it works.
Who is the study for?
This trial is for adults with advanced solid tumors that can't be removed or have spread, and standard treatments aren't working. They must not be pregnant, have had recent major surgery, or uncontrolled infections. For Phase 2, they need specific cancer types like high mutational burden cancers or virally associated tumors.Check my eligibility
What is being tested?
The study tests STAR0602, a new antibody-fusion molecule given through an IV to target certain antigens in tumors. It's an early-phase trial (1/2) checking safety and how well it works across multiple centers on participants with advanced solid tumors.See study design
What are the potential side effects?
While the exact side effects of STAR0602 are being studied, similar therapies often cause immune reactions, infusion-related discomforts, fatigue, possible organ inflammation due to targeted immune response and increased risk of infections.
START-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a high number of mutations, is MSI-H/dMMR, or is caused by a virus.
Select...
My cancer is advanced, cannot be surgically removed, and standard treatments have failed.
Select...
My cancer is one of the specific types listed and may have high mutation rates or be linked to a virus.
START-001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1
Phase 1 and 2 (Dose Escalation and Expansion): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)
Secondary outcome measures
Phase 1 and 2 (Dose Escalation and Expansion): Anti-drug Antibody (ADA) formation
Phase 1 and 2 (Dose Escalation and Expansion): Apparent Total Body Clearance (CL) for STAR0602
Phase 1 and 2 (Dose Escalation and Expansion): Apparent Volume of Distribution (Vd) for STAR0602
+9 moreSTART-001 Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2: Advanced Solid TumorsExperimental Treatment1 Intervention
Dose Expansion; Recommended Phase 2 Dose (RP2D) identified from Phase 1 will be used in Phase 2; Intervention: Drug: STAR0602
Group II: Phase 1: Advanced Solid TumorsExperimental Treatment1 Intervention
Dose Escalation; Intervention: Drug: STAR0602
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Who is running the clinical trial?
Marengo Therapeutics, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a high number of mutations, is MSI-H/dMMR, or is caused by a virus.I have another cancer that has not been in remission for at least a year.I do not have serious heart, blood vessel, stomach, inflammation, or lung problems.I haven't taken more than 10 mg of prednisone or any immune-suppressing drugs in the last week.I have wounds from surgery or injury that have not healed.I have not received a live virus vaccine in the last 4 weeks.I have HIV or hepatitis B/C with uncontrolled disease.My cancer is advanced, cannot be surgically removed, and standard treatments have failed.My brain metastases have been treated and I've had no symptoms for over 14 days.My cancer is one of the specific types listed and may have high mutation rates or be linked to a virus.I have not had major surgery or a serious injury in the last 8 weeks.I haven't had serious infections needing IV treatment in the last week.I have an autoimmune disease, but it may still qualify me.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Advanced Solid Tumors
- Group 2: Phase 2: Advanced Solid Tumors
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can potential participants access this experiment?
"Clinicaltrials.gov confirms that this particular study, which was launched on November 1st 2022, is not actively recruiting patients anymore. However, there are currently 2496 other trials in search of volunteers right now."
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