Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04152499 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by Klus Pharma.

Active
Registry status
Phase 1
Development phase
1,410
Enrollment target
20
Study locations

NCT04152499 is a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Klus Pharma. The registered enrollment target is 1,410 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 11 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04152499, a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Klus Pharma.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
1,410 participants
Enrollment target
20
Study locations

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

Conditions Studied

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

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

3 total trials

Interested in This Trial?

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, categorized as Phase 1. The registered enrollment target is 1,410 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (50% lower). The listed sponsor is Klus Pharma, which has 3 total studies on file at ClinicalTrials.gov.

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.

NCT04152499 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Anhui, Other, California.

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, Non-Small Cell Lung Cancer, Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma.

What interventions are being tested in trial NCT04152499?

The interventions under investigation include: SKB264 (DRUG).

Who is sponsoring clinical trial NCT04152499?

This trial is sponsored by Klus Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Breast Cancer

All registered trials for this condition

Non-Small Cell Lung Cancer

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.