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Active, not recruiting Phase 1Phase 2 Interventional

Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)

ClinicalTrials.gov ID: NCT04152499

Public ClinicalTrials.gov record NCT04152499. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 16, 2026, 11:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT04152499
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Klus Pharma Inc.
Industry
Enrollment
1,410 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2020 (Actual)
Primary completion
Nov 30, 2025 (Actual)
Completion
Nov 30, 2027 (Estimated)
Last update posted
Oct 9, 2026

2020 – 2027

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
Los Angeles Hematology Oncology Medical Group Glendale California 91204 —
University of California Los Angeles Los Angeles California 90404 —
Florida Cancer Specialists and Research Institute Sarasota Florida 34232 —
START MidWest Grand Rapids Michigan 49546 —
The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Oklahoma Cancer Specialists and Research Institute, LLC Tulsa Oklahoma 74146 —
Providence Cancer Institute, Franz Clinic Portland Oregon 97213 —
Mary Crowley Cancer Research Dallas Texas 75230 —
MD Anderson Cancer Center Houston Texas 77030 —
Virginia Cancer Specialists Fairfax Virginia 22031 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 99 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04152499, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 9, 2026 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04152499 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →