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New treatment option for Advanced Solid Tumors
Official title A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05592626
What this study is testing
What is STAR0602?
STAR0602 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative...
- For Phase 1, participants must have one of the following solid tumors:
- High mutational burden (TMB-H)
- Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
- Virally associated tumors
You likely can't join if
- Participants with a history of known autoimmune disease with exceptions of:
- Vitiligo;
- Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;
- History of Graves' disease, now euthyroid for \> 4 weeks;
- Hypothyroidism managed by thyroid replacement;
- Alopecia;
See the full eligibility criteria
- 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 or have intolerable...
- For Phase 1, participants must have one of the following solid tumors:
- High mutational burden (TMB-H)
- Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
- Virally associated tumors
- For Phase 2, participants must have one of the following solid tumors:
- TMB-H
- MSI-H/dMMR
- CRC (both Ras wild type and mutant)
- Virally associated tumors
- Metastatic triple negative breast cancer
- Platinum-resistant epithelial ovarian cancer
- Metastatic castration-resistance prostate cancer
- Primary stage IV or recurrent non-small cell lung cancer
- Immunogenic solid tumors (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)
- Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:
- No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent);
- No concurrent leptomeningeal disease or cord compression.
- Participants with a history of known autoimmune disease with exceptions of:
- Vitiligo;
- Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;
- History of Graves' disease, now euthyroid for \> 4 weeks;
- Hypothyroidism managed by thyroid replacement;
- Alopecia;
- Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.
- Adrenal insufficiency well controlled on replacement therapy.
- Major surgery or traumatic injury within 8 weeks before first dose of study drug.
- Unhealed wounds from surgery or injury.
- Treatment with \>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to...
- Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
- Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
- Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected...
- Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).
- Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
- Sacramento, California, United States
- Denver, Colorado, United States
- Celebration, Florida, United States
- Miami, Florida, United States
- Kansas City, Kansas, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Paris, France, France
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States; Sacramento, California, United States; Denver, Colorado, United States; Celebration, Florida, United States; Miami, Florida, United States; Kansas City, Kansas, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.