STAR0602 for Advanced Cancers

(START-001 Trial)

Recruiting at 31 trial locations

Overseen By Ke Liu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Marengo Therapeutics, Inc.

Must not be taking: Immune-suppressive drugs

Disqualifiers: Autoimmune disease, Cardiovascular, Infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

365 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, STAR0602 (also known as Invikafusp alfa), to determine its safety and effectiveness for individuals with advanced solid tumors that exhibit specific traits, such as a high number of genetic mutations or viral links. The trial consists of two phases: initially, it evaluates different doses to identify a safe amount, and then it assesses the effects of that dose. Suitable candidates have solid tumors that cannot be removed or treated with standard methods and have not undergone more than three different treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take more than 10 mg per day of prednisone (a type of steroid) or other immune-suppressive drugs within 7 days before starting the study drug, unless you have had an allergic reaction to iodinated contrast media.

Is there any evidence suggesting that STAR0602 is likely to be safe for humans?

Research has shown that STAR0602, also known as invikafusp alfa, has been tested for safety and effectiveness in people with advanced solid tumors. In earlier studies, some patients experienced tumor shrinkage, indicating a positive effect of the drug.

However, like many new treatments, some side effects have occurred. These can vary, but overall, patients have generally tolerated the drug well. The studies aim to find the right dose that balances safety with effectiveness. Since the research remains in the early stages, it focuses on understanding how people react to the treatment and what side effects might occur.

Prospective trial participants should discuss potential risks and benefits with their doctors based on the latest findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about STAR0602 because it offers a new approach for treating advanced solid tumors. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, STAR0602 is designed to target specific cancer pathways, potentially reducing side effects and improving effectiveness. This precision could mean better outcomes for patients, as it aims to halt tumor growth by focusing on the cancer's unique characteristics.

What evidence suggests that STAR0602 might be an effective treatment for advanced cancers?

Research has shown that STAR0602, also known as Invikafusp alfa, holds promise for treating advanced solid tumors. In studies, 52% of patients with tumors unresponsive to other treatments experienced tumor shrinkage. Among those with a high number of genetic changes in their tumors, about 24% saw significant tumor reduction. Additionally, in some patient groups, 79% had either tumor shrinkage or stability. This trial will evaluate STAR0602 in two phases: a dose escalation phase and a dose expansion phase. These results suggest that STAR0602 could be effective for individuals with certain advanced cancers. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My cancer has a high number of mutations, is MSI-H/dMMR, or is caused by a virus.

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.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

STAR0602 is administered intravenously to assess safety/tolerability and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)

Variable duration until MTD/RP2D is determined

Phase 2 Dose Expansion

STAR0602 at RP2D is administered to further evaluate safety and assess preliminary clinical activity

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STAR0602

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 2: Advanced Solid Tumors Experimental Treatment 1 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 Tumors Experimental Treatment 1 Intervention

Dose Escalation; Intervention: Drug: STAR0602

Who Is Running the Clinical Trial?

Marengo Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

420+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06827613

NCT06827613 | A Study of Invikafusp Alfa (STAR0602), ... This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS2687

A phase 1/2 study of invikafusp alfa (STAR0602), a first-in- ... Phase 2 of START-001 is a dose expansion at the RP2D, to further investigate the safety and anti-tumor activity of invikafusp in 9 cohorts of patients.

3. onclive.com onclive.com/view/invikafusp-alfa-boasts-high-disease-control-rate-in-checkpoint-inhibitor-resistant-solid-tumors

Invikafusp Alfa Boasts High Disease Control Rate in ... Invikafusp alfa led to tumor regression in target lesions in 52% of patients with tumor mutational burden–high (TMB-H) or microsatellite ...

4. prnewswire.com prnewswire.com/news-releases/marengo-presents-initial-phase-2-results-demonstrating-broad-single-agent-activity-of-invikafusp-alfa-across-multiple-pd-1-refractory-or--resistant-solid-tumors-as-a-late-breaking-oral-presentation-at-esmo-2025-302587142.html

Marengo Presents Initial Phase 2 Results Demonstrating ... 20.5% ORR and 79% DCR observed in heavily pretreated TMB-H or MSI-H/dMMR tumors across six major solid tumor types, including colorectal, ...

5. gastroenterologyadvisor.com gastroenterologyadvisor.com/news/invikafusp-alfa-gastrointestinal-cancer/

Invikafusp Alfa Demonstrates Activity in Gastrointestinal ... In patients with TMB-H, the overall response rate (ORR) was 23.5%, and the disease control rate was 63%. For patients with TMB-H metastatic ...

6. jitc.bmj.com jitc.bmj.com/content/12/Suppl_3/A1702

1470 START001: a phase 1/2 study of invikafusp alfa ... A first-in-human, multicenter Phase 1/2 study evaluating invikafusp as monotherapy in patients with anti-PD(L)1-resistant, antigen-rich solid tumors.