CT-95 in Advanced Cancers Associated With Mesothelin Expression

Context Therapeutics

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: CT-95

Study type: Interventional

Funder types: Industry

Identifiers

NCT06756035

CNTX-CT95-101

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

CT-95

Experimental group

Description:

Each dose cohort will have weekly dosing. Anticipate approximately 8 dose cohorts.

Treatment:

Drug: CT-95