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ACTIVE NOT RECRUITING Phase 1

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

NCT04152499 · View on ClinicalTrials.gov ↗

Study 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

Interventions

  • DRUG SKB264

Study Locations (20)

Anhui

  • The First Affiliated Hospital of Bengbu Medical University — Bengbu
  • Anhui Cancer Hospital — Hefei
  • AnHui Provincial Cancer Hospital — Hefei
  • The First Affiliated Hospital of Anhui Medical University — Hefei

Other

  • Centro de Estudios Clínicos SAGA — Providencia
  • Centro de Investigacion Clinica Bradford Hill — Santiago
  • Pontificia Universidad Catolica de Chile - CICUC — Santiago

California

  • Los Angeles Hematology Oncology Medical Group — Glendale
  • University of California Los Angeles — Los Angeles

Oklahoma

  • The University of Oklahoma Health Sciences Center — Oklahoma City
  • Oklahoma Cancer Specialists and Research Institute, LLC — Tulsa

Texas

  • Mary Crowley Cancer Research — Dallas
  • MD Anderson Cancer Center — Houston

Ontario

  • Princess Margaret Cancer Centre — Toronto
  • Sunnybrook Research Institute — Toronto

Florida

  • Florida Cancer Specialists and Research Institute — Sarasota

Michigan

  • START MidWest — Grand Rapids

Trial Details

FieldValue
Enrollment Target 1,410 participants
Start Date 2020-02-28
Est. Completion 2026-07-16
Phase Phase 1

Sponsor

Klus Pharma

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04152499

The ClinicalTrials.gov registry entry for NCT04152499 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,410 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Klus Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which SKB264 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04152499 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Anhui, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04152499 about?

NCT04152499 is a clinical study titled "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 (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 t...

What is the current status of trial NCT04152499?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 1,410 participants. The study started on 2020-02-28. Estimated completion is 2026-07-16.

What conditions does trial NCT04152499 study?

This clinical trial studies the following conditions: Breast Cancer, Cervical Cancer, Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04152499?

The interventions under investigation include: SKB264 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04152499?

This trial is sponsored by Klus Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04152499 being conducted?

This trial has 20 study locations across California, Florida, Michigan, Oklahoma, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial