Clinical trial 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 intravenous medicine being studied as a potential treatment for advanced solid tumors.
Also referred to as Invikafusp alfa.
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
- The study looks at how safe the drug is and whether it shows any early signs of helping tumors shrink.
- Who it's for
- Adults who have advanced solid tumors that have many target antigens.
- What's involved
- Participants receive STAR0602 through an IV, either by itself or together with standard chemotherapy, and have regular check‑ups and lab tests.
- Time commitment
- The trial runs for several months with multiple clinic visits for infusions and monitoring.
- 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...
- High mutational burden (TMB-H)
- Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
- Virally associated tumors
- Solid tumors generally considered as immunogenic (e.g., melanoma and renal cell carcinoma) are eligible without prior testing for TMB, MSI or viral...
You likely can't join if
- 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.
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...
- High mutational burden (TMB-H)
- Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
- Virally associated tumors
- Solid tumors generally considered as immunogenic (e.g., melanoma and renal cell carcinoma) are eligible without prior testing for TMB, MSI or viral status after the Sponsor's approval.
- TMB-H (not enrolling)
- MSI-H/dMMR (not enrolling)
- CRC (both Ras wild type and mutant) (not enrolling)
- NSCLC (recurrent or Primary Stage 4)
- CRC with pMMR/MSS (without TMB-H requirement) (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)
- No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent);
- No concurrent leptomeningeal disease or cord compression.
- people who have previously received a CPI (e.g., anti-PD-L1, anti-PD-1, anti CTLA 4) prior to enrollment must have CPI immune-related toxicity resolved to either Grade ≤ 1 or baseline (prior to the CPI) to be eligible...
- people who experienced previous CPI-related endocrine abnormalities are eligible for the study regardless of CTCAE grade if well controlled on replacement therapy.
- people who have had previous CPI-related Grade 3 to 4 pneumonitis, peri/myocarditis, colitis and bowel perforation, myositis, encephalitis, or peripheral neuropathy will need Sponsor approval.
- 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.
- Cytotoxic chemotherapy, small molecule inhibitors, radiation, treatment radiology procedure, or similar investigational therapies within ≤ 2 weeks or participants who have not recovered (i.e., ≤ Grade 1 or to baseline)...
- Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies within 6 weeks prior to the initiation of study drug or participants who have not recovered (i.e., ≤ Grade 1...
- 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.
- Bulky disease defined as any lesion ≥ 5 cm in greatest dimension unless approved by the Sponsor.
The study team makes the final eligibility decision.
Where it is enrolling
- Celebration, Florida, United States
- Kansas City, Kansas, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Madison, Wisconsin, United States
- Toronto, Ontario, Canada
- Villejuif, France
- Barcelona, Catalonia, Spain
- Madrid, Spain, Spain
- Madrid, Spain
- Valencia, Spain
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, but 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?
This study is enrolling now at Celebration, Florida, United States; Kansas City, Kansas, United States; Bethesda, Maryland, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; Columbus, Ohio, United States and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.