Informations générales (source: ClinicalTrials.gov)
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) (START-001)
Interventional
Phase 1/Phase 2
Marengo Therapeutics, Inc. (Voir sur ClinicalTrials)
janvier 2023
octobre 2026
10 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Lucas Frezouls | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Romain Di-Vincenzo | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69373 - Lyon - France | Severine Laurent | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33076 - Bordeaux - France | Audrey Laroche-Clary | Contact (sur clinicalTrials) | |||
| Oncopole Claudius Regaud IUCT - 31100 - Toulouse - France | Carlos Gomez-Roca, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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. Subjects should not
have received more than three lines of prior therapies for their advanced or
metastatic diseases.
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
3. For Phase 2, participants must have one of the following solid tumors:
1. TMB-H
2. MSI-H/dMMR
3. CRC (both Ras wild type and mutant)
4. Virally associated tumors
5. Metastatic triple negative breast cancer
6. Platinum-resistant epithelial ovarian cancer
7. Metastatic castration-resistance prostate cancer
8. Primary stage IV or recurrent non-small cell lung cancer
9. Immunogenic solid tumors
(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.
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. Subjects should not
have received more than three lines of prior therapies for their advanced or
metastatic diseases.
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
3. For Phase 2, participants must have one of the following solid tumors:
1. TMB-H
2. MSI-H/dMMR
3. CRC (both Ras wild type and mutant)
4. Virally associated tumors
5. Metastatic triple negative breast cancer
6. Platinum-resistant epithelial ovarian cancer
7. Metastatic castration-resistance prostate cancer
8. Primary stage IV or recurrent non-small cell lung cancer
9. Immunogenic solid tumors
(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.
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. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders,
inflammatory processes, pulmonary compromises
6. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment
within 7 days prior to the initiation of study drug.
7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of
study drug administration. Inactivated annual influenza vaccination is allowed.
8. Participants who are known to be human immunodeficiency virus positive or hepatitis
B or C positive and have uncontrolled disease.
9. 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.
10. 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).
11. Hepatic metastases unless adequately treated, either locally (e.g., by surgery,
radiofrequency ablation, or chemoembolization) or systemically or both, and stable
for 3 months.