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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: Active Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by Klus Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,410 participants |
| Start Date | 2020-02-28 |
| Est. Completion | 2026-07-16 |
| Phase | Phase 1 |
What the registry record for NCT04152499 still lists
NCT04152499 is an interventional study that assigns participants to a tested intervention. Its 1,410 participants enrollment target places it among the larger protocols in the corpus, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (50% lower).
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 names 20 study sites across 11 states, led by 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.
Where NCT04152499's enrollment target sits among peer trials
1,410 90th of 1224 higher than 1,135 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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