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NCT06756035

CT-95 in Advanced Cancers Associated With Mesothelin Expression

StatusTerminated
PhasePhase 1
Primary completion
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 12 versions: 12 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial terminated Sponsor's reason: The study was halted prematurely and will not resume; participants are no longer receiving intervention or undergoing evaluations. The termination was not due to any safety or efficacy concerns. Show 5 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Final enrollment: 19 participants (planned 70)
    • Primary completion date changed from estimate of Dec 2026 to Oct 9, 2026
    • Study sites: 9 to 8
    • Study description revised
  2. Study description expanded, about 77 wordsv11
  3. Study sites: 8 to 9v10
  4. Study sites: 7 to 8v9
  5. Study sites: 6 to 7v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 5 to 6v7
  2. Study sites: 3 to 5v6
  3. Study sites: 2 to 3v5
  4. Enrollment target: 50 to 70
    • Study description expanded, about 20 words
    v4
  5. Study sites: 1 to 2v3
  6. Start date changed from estimate of Jan 2025 to Mar 31, 2025v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Minor: routine updates

Endpoints

Primary

Determine the MTD or RD of CT-95 [Safety and Tolerability]
Timeframe: From date of first dose of CT-95 until 28 days following the first dose.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.

Secondary (6)

Evaluate Response Rates [Anti-tumor Activity]
Evaluate Progression-free Survival [Anti-tumor Activity]
Evaluate Overall Survival [Survival]
Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics]
Evaluate the Area Under the Curve (AUC) [Pharmacokinetics]
Show 1 moreShow less
Evaluate Anti-Drug Antibodies [Immunogenicity]

Arms and interventions

CT-95Experimental

Phase 1a: Dose Escalation - each dose cohort will assess toxicity 28 days following the first dose of CT95 anticipate a total of 8 dose cohorts. Phase 1b: Dose Expansion - approximately 80 participants will be evaluated in 2-4 indication-specific expansion cohorts.

Drugs: CT-95

Sites

8 sites in 1 country