CT-95 in Advanced Cancers Associated With Mesothelin Expression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PD-1 Antibody Expressing CAR T Cells for Mesothelin Positive Advanced Malignancies

NCT03030001

Solid Tumor, Adult Advanced Cancer

UNKNOWN PHASE1/PHASE2

Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma

NCT01435369

Melanoma Malignant Melanoma

COMPLETED PHASE2

A Study of NI-1801 in Patients with Mesothelin Expressing Solid Cancers

NCT05403554

Epithelial Ovarian Cancer Triple Negative Breast Cancer Non-squamous Non-small-cell Lung Cancer +2 more

RECRUITING PHASE1

PD-1 Antibody Expressing mesoCAR-T Cells for Mesothelin Positive Advanced Solid Tumor

NCT03615313

Advanced Solid Tumor

UNKNOWN PHASE1/PHASE2

CT-011 and p53 Genetic Vaccine for Advanced Solid Tumors

NCT01386502

Breast Cancer Colon Cancer Pancreatic Cancer +2 more

WITHDRAWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CT-95

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

Group Type EXPERIMENTAL

CT-95

Intervention Type DRUG

Weekly IV dosing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT-95

Weekly IV dosing

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No