CT-95 in Advanced Cancers Associated With Mesothelin Expression

Condition(s) studied

Investigational drug(s) / intervention(s)

CT-95: MSLN bispecific antibody to be administered according to the dose and schedule of the assigned cohort until documentation of disease progression (or confirmed disease progression), unacceptable toxicity, or participant/physician decision.

Study summary

This is a Phase 1a/1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with advanced (recurrent, unresectable, or metastatic) cancers associated with MSLN expression.

Eligibility

Primary outcome measure(s)

• Determine the MTD or RD of CT-95 [Safety and Tolerability] — From date of first dose of CT-95 until 28 days following the first dose.
  The frequency of dose-limiting toxicities (DLTs) will be analyzed along with safety and tolerability measures to determine the MTD or RD of CT-95.
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.
  The frequency and severity of adverse events, serious adverse events, and adverse events of special interest will be analyzed.

Trial sites (9)

More Context Therapeutics Inc. trials in the USA

Other trials for the same condition