Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)
A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies
Sponsor: Klus Pharma Inc.
No open prediction endpoints
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Primary Endpoints (CT.gov)
Phase I: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)
Time frame: Assess up to 12 months
Phase II: Objective Response Rate (ORR)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary Endpoints
Phase I: Dose Limiting Toxicities (DLTs)
Phase I: Overall safety and tolerability profile
Phase I: Preliminary efficacy based on ORR (Objective Response Rate)
Eligibility Criteria
Diagnosis and Main Criteria for Inclusion: Inclusion Criteria: Patients must meet the following criteria for inclusion into the study: Phase I: 1. Patients must be able to provide documented voluntary informed consent. 2. Male or female patient aged 18-75 years. 3. Histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include but not limited to the following tumor types: Breast cancer Ovarian epithelial cancer Non-small cell lung cancer Gastric adenocarcinoma Small cell lung cancer Urothelial carcinoma Note: Confirmation of TROP2 expression by immunohistology or other means is not required, but the Sponsor will request tissue specimens from fresh or archived materials for determination of TROP2 expression. 4. Measurable disease by CT/MRI during dose escalation. 5. Patients should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, o…
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