Clinical trial NCT06756035: CT-95 in Advanced Cancers Associated With Mesothelin Expression
Official title: Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Mesothelin-Expressing Tumors
Epithelial Ovarian Cancer
Malignant Pleural Mesothelioma, Advanced
Malignant Peritoneal Mesothelioma, Advanced
Pancreatic Adenocarcinoma Advanced or Metastatic
Lung Adenocarcinoma Metastatic
Cholangiocarcinoma Advanced
Cholangiocarcinoma Non-resectable
Mesothelin-expressing Advanced Cancers
Mesothelin-positive Advanced Malignant Solid Tumors
Colorectal Cancer
Keywords: Phase 1 Dose Escalation Study
CT-95
Advanced, recurrent cancers
Unresectable, metastatic cancers
Cancers associated with mesothelin expression
Lead sponsor: Context Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.

Detailed description: The Phase 1a Dose Escalation portion of the trial will enroll subjects in one of approximately 8 dose escalation cohorts to assess the safety and tolerability of CT-95, as well as determine the maximum tolerated dose (MTD) or other recommended dose(s) for expansion (RDE\[s\]) for further study in 2 dose optimization cohorts. Subjects will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle.

The Phase 1b Dose Expansion portion will evaluate CT-95 in indication-specific expansion cohorts

Eligibility criteria: Inclusion Criteria:

* ECOG 0 or 1
* Subjects with evaluable disease per RECIST 1.1 or mRECIST
* Subjects with adequate organ function.
* Subjects with advanced cancers associated with mesothelin expression

Exclusion Criteria:

* Uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study.
* Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy
* Concurrent participation in another investigational clinical trial.
* Evidence of leptomeningeal disease

Primary outcomes:
measure: 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.
measure: 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 outcomes:
measure: Evaluate Response Rates [Anti-tumor Activity]
timeFrame: At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first
measure: Evaluate Progression-free Survival [Anti-tumor Activity]
timeFrame: At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.
measure: Evaluate Overall Survival [Survival]
timeFrame: From the time of the first dose of CT-95 until approximately two years post-first dose.
measure: Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics]
timeFrame: From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.
measure: Evaluate the Area Under the Curve (AUC) [Pharmacokinetics]
timeFrame: From date of first dose of CT-95 for 5 months or treatment discontinuation, whichever comes first.
measure: Evaluate Anti-Drug Antibodies [Immunogenicity]
timeFrame: From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Context Investigational Site
state: New Jersey
city: San Antonio
country: United States
facility: Context Investigational Site
state: Texas
Study officials:
affiliation: Context Therapeutics Inc.
name: Karen Smith, MD, PhD, MBA, LLM
role: STUDY_DIRECTOR
References: