What side effects are associated with this type of intervention?

Treatments for solid tumors that target specific antigens, such as immune checkpoint inhibitors and bifunctional antibody-fusion molecules like STAR0602, commonly cause immune-related adverse events (irAEs). These include pneumonitis, colitis, hepatitis, endocrinopathies (e.g., thyroiditis, adrenal insufficiency), and dermatologic reactions (e.g., rash, pruritus). Other frequent side effects are fatigue, diarrhea, and infusion-related reactions. Severe but less common side effects can include myocarditis and neurotoxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that target specific antigens. Notable examples include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, and are used in various cancers such as melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. Additionally, drugs like dabrafenib and trametinib target the BRAF V600 mutation in melanoma. These treatments work by enhancing the immune system's ability to recognize and attack cancer cells, similar to the mechanism likely employed by STAR0602 in targeting antigen-rich advanced solid tumors.

What other types of research exist?

Promising alternatives to STAR0602 for treating advanced solid tumors include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, as shown in the KEYNOTE-189 trial for non-small cell lung cancer. 2) GD2-CAR T cell therapy, particularly for H3K27M-mutated diffuse midline gliomas. 3) ONC201, a selective DRD2 antagonist, for recurrent glioblastoma and H3 K27M-mutant diffuse midline glioma. 4) Atezolizumab (Tecentriq) combined with bevacizumab, as demonstrated in the IMmotion151 trial for renal cell carcinoma. 5) Nivolumab (Opdivo) plus ipilimumab (Yervoy), as shown in the CheckMate 743 trial for malignant pleural mesothelioma.

← Back to Search

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.

Must not have

Second primary invasive malignancy not in remission for ≥ 1 year.

Unhealed wounds from surgery or injury.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called STAR0602 to see if it is safe and effective for treating advanced cancers with specific markers. The drug is given through an IV and aims to find and destroy cancer cells by recognizing these markers. The study will first determine the best dose and then see how well the drug works in patients.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have another cancer that has not been in remission for at least a year.

Select...

I have wounds from surgery or injury that have not healed.

Select...

I have HIV or hepatitis B/C with uncontrolled disease.

Select...

I haven't had serious infections needing IV treatment in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors, such as those being studied with STAR0602, often involve targeting specific antigens present on tumor cells. Monoclonal antibodies can bind to these antigens, marking the cancer cells for destruction by the immune system. Immune checkpoint inhibitors, like anti-PD-1 or anti-CTLA-4 antibodies, work by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. CAR T-cell therapies involve modifying a patient's T cells to express receptors that specifically target tumor antigens, leading to direct tumor cell killing. These targeted therapies are crucial for solid tumor patients as they offer a more precise treatment approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.