A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests STAR0602, given through a vein, alone or with chemotherapy. It looks at safety, side effects, and early signs that treatment works in people with certain advanced solid tumors.
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 and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must have a solid tumor confirmed by a tissue test that cannot be removed by surgery, has grown nearby, or has spread. Standard treatments to cure it must be unavailable, no longer work, or cause side effects you cannot tolerate.
- You must have had no more than 3 prior treatment plans for advanced or spreading cancer. For Phase 2 groups 8 and 10, the limit is 1.
- For Phase 1, your tumor must have many gene changes, problems repairing DNA, or a link to a virus. Some cancers that tend to trigger an immune response, such as melanoma or kidney cancer, may qualify with study sponsor approval.
- Phase 2 lists non-small cell lung cancer that has returned or was stage 4 when first found, and colon or rectal cancer with normal DNA repair (pMMR/MSS). Other listed groups are not enrolling; more tumor types may be added as data become available.
- If cancer spread to your brain or spinal cord caused symptoms, it must be treated and cause no symptoms for at least 14 days. You cannot need ongoing treatment for it, have cancer in the surrounding lining, or have pressure on the spinal cord.
- Side effects from past immune checkpoint drugs, which help the immune system fight cancer, must be mild or back to your usual level. Hormone problems may qualify if controlled with replacement medicine. Some past severe immune side effects need sponsor approval.
Who can't join
- An autoimmune disease, where the immune system attacks the body, may rule you out. Exceptions include certain skin conditions, hair loss, controlled thyroid or adrenal problems, and arthritis managed without stronger immune-suppressing drugs.
- You cannot have had major surgery or a serious injury within 8 weeks before treatment, or have wounds that have not healed.
- You cannot have used more than 10 mg of prednisone daily, a similar steroid dose, or other immune-suppressing drugs within 7 days. Skin, eye, inhaled, and nasal steroids are allowed; contrast-dye allergy treatment may be an exception.
- Recent cancer treatment may rule you out: certain treatments within 2 weeks, or antibody-based treatments within 6 weeks. Past treatment side effects must generally be mild or back to your usual level; some nerve damage or hair loss may be allowed.
- You cannot have serious heart, blood vessel, digestive, lung, or inflammation problems; an active infection needing injected treatment within 7 days; or uncontrolled HIV, hepatitis B, or hepatitis C. Live-virus vaccines within 4 weeks are not allowed; the yearly inactivated flu shot is allowed.
- Another invasive cancer must generally have been in remission for at least 1 year. Exceptions apply to certain skin, cervical, prostate, and slow-growing cancers, but not slow-growing lymphomas.
- You cannot be pregnant, likely to become pregnant, or breastfeeding.
- Cancer that has spread to the liver must be adequately treated and stable for 3 months. Any tumor measuring 5 cm or more needs sponsor approval.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. 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 toxicities. Participants should not have received more than three regimens of prior therapies for their advanced or metastatic diseases. For Phase 2 Cohorts 8 and 10 (see below), participants should not have received more than one line of prior therapy. 2. For Phase 1, participants must have one of the following solid tumors: 1. High mutational burden (TMB-H) 2. Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR) 3. Virally associated tumors 4. 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. 3. For Phase 2, participants must have one of the following solid tumors: 1. TMB-H (not enrolling) 2. MSI-H/dMMR (not enrolling) 3. CRC (both Ras wild type and mutant) (not enrolling) 4. NSCLC (recurrent or Primary Stage 4) 5. 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.) 4. 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. 5. Subjects 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 for enrollment. * Subjects who experienced previous CPI-related endocrine abnormalities are eligible for the study regardless of CTCAE grade if well controlled on replacement therapy. * Subjects 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. Exclusion Criteria: 1. 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. 2. Major surgery or traumatic injury within 8 weeks before first dose of study drug. 3. Unhealed wounds from surgery or injury. 4. 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 iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed. 5. Prior therapy within the following timeframe before planned infusion of STAR0602 as follows: * Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventional radiology procedure, or similar investigational therapies within ≤ 2 weeks or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to a previously administered agent; * 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 or to baseline) from AEs due to agents administered more than 4 weeks earlier. Note: Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study. 6. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises 7. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. 8. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. 9. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease. 10. 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 melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas. 11. 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). 12. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months. 13. Bulky disease defined as any lesion ≥ 5 cm in greatest dimension unless approved by the Sponsor.
Study sites (13)
CA
- UC Davis Comprehensive Cancer Center · Sacramento, CA 95817More trials in Sacramento
FL
- AdventHealth Celebration · Celebration, FL 34747Guru Sonpavde, MD · Study contact · 407 303 2024Guru Sonpavde, MD · Principal investigatorMore trials in Celebration
- University of Miami Sylvester Comprehensive Cancer Center · Miami, FL 33136More trials in Miami
KS
- The University of Kansas Cancer Center · Kansas City, KS 66160Weijing Sun, MD · Study contact · wsun2@kumc.eduWeijing Sun, MD · Principal investigatorMore trials in Kansas City
MA
- Massachusetts General Hospital Cancer Center · Boston, MA 02114Ryan Sullivan, MD · Study contact · (617) 643-3614Ryan Sullivan, MD · Principal investigatorMore trials in Boston
MD
- National Institutes of Health · Bethesda, MD 20892Melissa Walker · Study contact · walkerme@mail.nih.govStephanie Hicks · Study contact · stephanie.hicks2@nih.govJames Gulley, MD, PhD · Principal investigatorMore trials in Bethesda
MI
- Karmanos Cancer Institute · Detroit, MI 48201Victoria LaBush · Study contact · 313-576-8411Wasif Saif, MD · Principal investigatorMore trials in Detroit
OH
- The Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Asrar Alahmadi, MD · Study contact · Asrar.Alahmadi@osumc.eduAsrar Alahmadi, MD · Principal investigatorMore trials in Columbus
TN
- Sarah Cannon Research Institute Oncology Partners (SCRI-Nashville) · Nashville, TN 37203Abi Warnke · Study contact · Abi.Warnke@scri.comMeredith Pelster, MD · Principal investigatorMore trials in Nashville
TX
- The University of Texas, MD Anderson Cancer Center · Houston, TX 77030Pia Morelli, MD, PhD · Study contact · MPMorelli@mdanderson.orgPia Morelli, MD, PhD · Principal investigatorMore trials in Houston
- UT Health Mays Cancer Center · San Antonio, TX 78229Sheniell Granato · Study contact · 210-450-1950 · granatos@uthscsa.eduSukeshi Patel Arora, MD · Principal investigatorMore trials in San Antonio
WA
- Fred Hutchinson Cancer Center · Seattle, WA 98109More trials in Seattle
WI
- University of Wisconsin- Madison · Madison, WI 53792Vincent Ma, MD · Study contact · vtma@medicine.wisc.eduVincent Ma, MD · Principal investigatorMore trials in Madison