Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Zev A. Wainberg, MD (ucla)
Headshot of Zev A. Wainberg
Zev A. Wainberg

Description

Summary

Official Title

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

Details

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).

Keywords

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, TROP2, ADC, Carcinoma, Lung Neoplasms, Adenocarcinoma, Small Cell Lung Carcinoma, Squamous Cell Carcinoma of Head and Neck, Ovarian Epithelial Carcinoma, Endometrial Neoplasms, SKB264, Triple Negative Breast Cancer, HR+/ HER2- Breast Cancer, Cervical Cancer

Eligibility

Locations

Lead Scientist at University of California Health

  • Zev A. Wainberg, MD (ucla)
    Zev Wainberg, M.D., holds the Estelle, Abe, and Marjorie Sanders Chair in Cancer Research.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Klus Pharma Inc.
ID
NCT04152499
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 1300 study participants
Last Updated