A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 34 days later Sep 1, 2027 → Oct 5, 2027
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 1, 2027 to Oct 5, 2027
    • Study sites: 19 to 18
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 9 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 180 to confirmed 126
    • Site details revised at 19 of 19 sites
    v28
  3. Study sites: 18 to 19v27
  4. Study sites: 17 to 18v26
  5. Study sites: 16 to 17v25
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 15 to 16v24
  2. Primary and study completion dates: Feb 20, 2026 to Sep 1, 2027
    • Study sites: 13 to 15
    v23
  3. Re-verified, no change to tracked fieldsv22
  4. Study sites revised (13)v21
  5. Eligibility criteria expanded, about 32 words
    • Study title revised
    v20
  6. Study sites: 12 to 13v19
  7. Study sites: 11 to 12v18
  8. Study sites: 10 to 11v17
  9. Primary endpoints revised (5)v16 Show 7 more changesShow less
    • Enrollment target: 220 to 180
    • Study sites: 8 to 10
    • Interventions: KFA115 (Drug), tislelizumab (Drug) to KFA115 (Drug), pembrolizumab (Drug)
    • Eligibility criteria shortened, about 45 words
    • Secondary endpoints: 10 to 9
    • Study description revised
    • Study title shortened, about 1 word
  10. Study sites: 7 to 8v15
  11. Eligibility criteria expanded, about 53 wordsv14
  12. Study sites: 6 to 7v13
  13. Site contacts updated at 1 of 6 sitesv12
  14. Study sites: 5 to 6v11
  15. Primary completion date: Sep 12, 2025 to Feb 20, 2026
    • Study completion date: Sep 15, 2025 to Feb 20, 2026
    v10
  16. Study sites: 4 to 5v9
  17. Study sites: 3 to 4v8
  18. Study sites: 2 to 3v7
  19. Study sites: 1 to 2v6
  20. Re-verified, no change to tracked fieldsv5
  21. Start date: Oct 20, 2022 to Oct 26, 2022v4
  22. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  23. Start date: Nov 3, 2022 to Oct 20, 2022v2
  1. Study First Submitted
  • 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.
Novartis
556 trials monitored
See 33 trials at risk
Breast Cancer
5,466 trials monitored
See 312 trials at risk
Lung Cancer
4,803 trials monitored
See 272 trials at risk
Colorectal Cancer
3,410 trials monitored
See 164 trials at risk
and 9 more diseases
The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose.
Trial Details
NCT Number NCT05544929
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma, Carcinoma, Renal Cell, Carcinoma, Ovarian Epithelial, Nasopharyngeal Carcinoma, Carcinoma, Thymic, Anal Cancer, Mesothelioma +4 more
Related terms Adenocarcinoma, Clear Cell, Anus Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Ovarian Epithelial, Carcinoma, Renal Cell, Colonic Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Head and Neck Neoplasms, Intestinal Neoplasms, Kidney Neoplasms, Lung Neoplasms, Melanoma, Mesothelioma, Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Neoplasms, Ovarian Neoplasms, Rectal Neoplasms, Skin Neoplasms, Squamous Cell Carcinoma of Head and Neck, Thymoma, Thymus Neoplasms, Triple Negative Breast Neoplasms
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov