| TITRE |
(EN) A Multicenter, Open-label, Phase 2, Basket Study to Evaluate the Efficacy and Safety of SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors |
| PROTOCOLE ID |
SKB264-II-06 |
| CLINICAL TRIAL.gov ID |
NCT05642780 |
| TYPE(S) DE CANCER |
Tumeurs solides |
| PHASE |
Phase II |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CHUM
1051 rue Sanguinet
(514) 890-8000
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Diane Provencher
|
| COORDONATEUR(RICE) |
Adeline Hamon
parc.eligibilite.chum@ssss.gouv.qc.ca
514-890-8000 poste 30737
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 .
- Subjects with expected survival ≥ 3 months.
- Cohort A: Subjects with recurrent or metastatic cervical cancer
- Cohort B: Subjects with locally advanced or metastatic urothelial carcinoma
- Cohort C: Subjects with recurrent ovarian cancer
- Cohort D: Subjects with metastatic prostate cancer
- Subjects have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Subjects able to provide tumor blocks or slides for biomarker test.
- Subjects have relatively good organ function and bone marrow function.
- Subjects must have recovered from all toxicities from previous therapy with the exception of toxicities not considered a safety risk.
- Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Subject is capable of giving signed informed consent.
|
| CRITÈRES D'EXCLUSION |
(EN)
- Subjects with active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
- Subjects who suffer from cardiovascular diseases of clinical significance.
- Subjects with serious and/or uncontrolled concomitant diseases.
- Subjects diagnosed active hepatitis B or hepatitis C.
- Subjects have known human immunodeficiency virus (HIV) infection that is not well controlled.
- Subjects with known active tuberculosis.
- Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients of pembrolizumab or SKB264.
- Subjects with history of allogeneic tissue/solid organ transplant.
- Subjects previously treated with TROP2 targeted therapy.
- Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period.
- Subjects participating in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an intervention study.
- The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.
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