Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04152499 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: MK-2870-001
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Dec 31, 2026 to Nov 30, 2025 Completion pushed from Dec 31, 2026 to Nov 30, 2027 Show 1 more changeShow less
    • Completion pushed from Dec 31, 2026 to Nov 30, 2027
  2. Eligibility criteria expanded, about 59 words Site details revised at 8 of 109 sites · Publications: details revised at 2 of 2 entries Show 2 more changesShow less
    • Site details revised at 8 of 109 sites
    • Publications: details revised at 2 of 2 entries
  3. Primary completion date: Dec 31, 2025 to Dec 31, 2026 Completion date: Jul 16, 2026 to Dec 31, 2026v18 Show 1 more changeShow less
    • Completion date: Jul 16, 2026 to Dec 31, 2026
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 1300 to confirmed 1410 · Study sites: 153 to 109 · Primary completion date: Aug 1, 2025 to Dec 31, 2025 · 1 morev17 Show 4 more changesShow less
    • Enrollment target: estimated 1300 to confirmed 1410
    • Study sites: 153 to 109
    • Primary completion date: Aug 1, 2025 to Dec 31, 2025
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 172 to 153v16
Show 14 earlier versionsHide 14 earlier versions
  1. Enrollment target: 430 to 1300 Primary completion date: Nov 2024 to Aug 1, 2025 · Study sites: 56 to 172 · Completion date: Dec 2025 to Jul 16, 2026 · 1 morev15 Show 4 more changesShow less
    • Primary completion date: Nov 2024 to Aug 1, 2025
    • Study sites: 56 to 172
    • Completion date: Dec 2025 to Jul 16, 2026
    • Eligibility criteria shortened, about 682 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 50 to 56v14
  3. Enrollment target: 250 to 430 Study sites: 46 to 50 · Eligibility criteria expanded, about 859 words · Secondary endpoints revised (15) · 1 morev13 Show 4 more changesShow less
    • Study sites: 46 to 50
    • Eligibility criteria expanded, about 859 words
    • Secondary endpoints revised (15)
    • Study arms: 7 to 11

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Nov 2022 to Nov 2024 Completion date: Dec 2022 to Dec 2025 · Site details revised at 1 of 46 sitesv12 Show 2 more changesShow less
    • Completion date: Dec 2022 to Dec 2025
    • Site details revised at 1 of 46 sites
  5. Primary completion date: Feb 2022 to Nov 2022v11
  6. Study sites: 38 to 46v10
  7. Study sites: 31 to 38 Primary completion date: Dec 2021 to Feb 2022v9 Show 1 more changeShow less
    • Primary completion date: Dec 2021 to Feb 2022
  8. Site details revised at 1 of 31 sitesv8
  9. Enrollment target: 78 to 250 Primary endpoints revised (2) · Study sites: 11 to 31 · Eligibility criteria expanded, about 63 words · 2 morev7 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 11 to 31
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: 14 to 15
    • Study arms: 4 to 7

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 10 to 11v6
  11. Study sites: 7 to 10v5
  12. Re-verified, no change to tracked fieldsv4
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 7 · Start date changed from estimate of Feb 2020 to Feb 28, 2020 · Secondary endpoints revised (14) · 1 morev3 Show 4 more changesShow less
    • Study sites: 0 to 7
    • Start date changed from estimate of Feb 2020 to Feb 28, 2020
    • Secondary endpoints revised (14)
    • Study title shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  14. Start date: Dec 2019 to Feb 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Klus Pharma Inc.
3 trials monitored
See all monitored trials
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
and 7 more diseases
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
Trial Details
NCT Number NCT04152499
Lead Sponsor Klus Pharma Inc.
Conditions 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 +2 more
Enrollment 1,410 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov