NCT04152499

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,410 (actual)
• Sponsor: Klus Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I-II, First-in-Human Study of SKB264 (Sac-TMT; MK-2870) in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies. Patient must have historically documented, incurable, locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types: 1. Triple negative breast cancer 2. Epithelial ovarian cancer 3. Non-small cell lung cancer 4. Gastric adenocarcinoma/Gastroesophageal junction adenocarcinoma 5. Small cell lung cancer 6. HR+/ HER2-breast cancer 7. Head and neck squamous cell carcinoma 8. Endometrial carcinoma 9. Urothelial carcinoma 10. Cervical cancer

Detailed description

This is an open label, Phase I-II, first in human (FIH) study for SKB264 as monotherapy in patients who have locally advanced unresectable or metastatic solid tumor that is refractory to all standard therapies. TROP2 (trophoblast antigen 2) assessments will not be performed prior to enrollment but it will be assessed retrospectively. Confirmation of TROP2 (trophoblast antigen 2) expression by immunohistology or other means is not required, but the Sponsor will request fresh tumor biopsy or tissue specimens from archived materials for determination of TROP2 (trophoblast antigen 2) expression retrospectively. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy whose tumor is refractory to standard therapies. Patients will receive study drug as a single IV infusion at the prescribed dose level at each administration. Cycles will continue until disease progression or unacceptable toxicity. The study is divided into 2 parts (Phase I and Phase II).

Conditions

• Epithelial Ovarian Cancer
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Urothelial Carcinoma
• Non-Small Cell Lung Cancer
• Small-Cell Lung Cancer
• Endometrial Carcinoma
• Head and Neck Squamous Cell Carcinoma
• Breast Cancer
• Cervical Cancer

Interventions

Type	Name	Description
DRUG	SKB264	SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Timeline

• Start date: 2020-02-28
• Primary completion: 2025-12-31
• Completion: 2026-07-16
• First posted: 2019-11-05
• Last updated: 2025-05-20

Locations

109 sites across 6 countries: United States, Canada, Chile, China, South Korea, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study