CT-95 in Advanced Cancers Associated With Mesothelin Expression

Part of paid clinical trials in Denver, Colorado.

Sponsor
Context Therapeutics Inc.
Study ID
NCT06756035
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cholangiocarcinoma Advanced
  • Cholangiocarcinoma Non-resectable
  • Colorectal Cancer
  • Epithelial Ovarian Cancer
  • Lung Adenocarcinoma Metastatic
  • Malignant Peritoneal Mesothelioma, Advanced
  • Malignant Pleural Mesothelioma, Advanced
  • Mesothelin-Expressing Tumors
  • Mesothelin-expressing Advanced Cancers
  • Mesothelin-positive Advanced Malignant Solid Tumors
  • Pancreatic Adenocarcinoma Advanced or Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CT-95 — DRUG
    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 Details

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.

Key Dates

First listed
Jan 1, 2025
Start date
Mar 31, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CT-95
    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.

Primary Outcome Measure

Determine the MTD or RD of CT-95 [Safety and Tolerability] [ Time Frame: From date of first dose of CT-95 until 28 days following the first dose. ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Context Investigational SiteDenverColorado80218
Front Desk
[email protected]
720-754-2610
Context Investigational SiteChicagoIllinois60637
Cancer Clinical Trials
[email protected]
773-702-6233
Context Investigational SiteGrand RapidsMichigan49546
Ashley Spagnuolo
[email protected]
616-954-5552
Context Investigational SiteHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
Context Investigational SitePhiladelphiaPennsylvania19107
Ask Phase1
[email protected]
215-586-0199
University of PennsylvaniaPhiladelphiaPennsylvania19104
Andrea Standish
[email protected]
215-662-2419
Context Investigational SiteNashvilleTennessee37203
Sarah Cannon Research Institute
844-482-4812
Context Investigational SiteSan AntonioTexas78229
Clinical Trial Navigator
[email protected]
210-580-9521
Context Investigational SiteSan AntonioTexas78229
Isabel Jimenez
[email protected]
210-593-5265
Christina Santana
[email protected]

Find similar trials in Denver, CO

By condition
Colorectal cancerOvarian cancer
By specialty
OncologyGI oncologyGynecologic oncologyWomen's health
By research site
Context Investigational Site· Denver, COContext Investigational Site· Chicago, ILContext Investigational Site· Grand Rapids, MIContext Investigational Site· Hackensack, NJContext Investigational Site· Philadelphia, PAUniversity of Pennsylvania· Philadelphia, PA

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