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CT-95 is being developed for cancers including pancreatic, ovarian and mesothelioma and other solid tumors.
The study will evaluate the safety and efficacy of CT-95 in mesothelin-expressing tumors.
The first patient has been dosed in a phase 1 clinical trial of CT-95 among patients with mesothelin-expressing solid tumors.
The development was announced in a news release issued by biopharmaceutical company Context Therapeutics Inc.
CT-95 is a mesothelin and CD3 T cell engaging bispecific antibody that is designed to target mesothelin-expressing cancers. Mesothelin, as the company explained in the news release, is a membrane protein that is overexpressed in approximately 30% of all cancers and has limited expression in normal tissue.
The company noted in the news release that CT-95 is being developed as a therapy for advanced cancers that are associated with mesothelin expression including pancreatic cancer, ovarian cancer, mesothelioma and other solid tumors.
The clinical trial is currently recruiting, and is being held at one location in San Antonio, Texas, according to its listing on clinicaltrials.gov. The trial has an estimated primary completion date of December 2026 and an estimated study completion date of December 2028, according to the listing.
Context stated in the news release that it anticipates sharing initial data from the trial in mid-2026.
“Dosing of the first patient in our CT-95 phase 1 clinical trial represents another step forward in our mission to develop next generation precision immunotherapies for solid tumors,” said Martin Lehr, CEO of Context, in the news release.
The trial is an open-label, dose e
Pharmacokinetics: study of how the drug is absorbed, distributed, metabolized and excreted in the body, providing insight into the drug's action and optimal dosing.
Overall response rate: the portion of patients who respond partially or completely to treatment.
Duration of response: how long a patient responds to treatment.
Disease control rate: the portion of patients who experience a complete response, partial response or stable disease.
scalation and expansion study evaluating the safety and effectiveness of CT-95 among patients with mesothelin-expressing advanced solid tumors including lung cancer, ovarian cancer, pancreatic cancer and mesothelioma, according to the news release.
The company stated that the dose escalation and dose expansion portions of the trial are expected to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of the treatment by overall response rate, duration of response and disease control rate.
The news release stated that the dose escalation portion of the study is expected to enroll up to 30 patients, and the clinicaltrials.gov listing said that the trial will enroll an estimated 50 patients in total.
CT-95, as detailed in the news release, is a bispecific T-cell engager. Bispecific T-cell engagers, a type of targeted therapy also known as a BiTE therapy, are substances made in a laboratory that bind to two target proteins on the surface of different cells, such as a protein on a healthy T cell, which is a type of immune cell, and to a protein on cancer cells, as explained by the National Cancer Institute on its website.
This binding brings T cells and cancer cells close together to make it easier for the T cells to more effectively kill the cancer cells.
This is the second active clinical trial from Context, as it follows the dosing of the first patient in a trial evaluating the bispecific antibody CTIM-76, which is targeting CLDN6-positive tumors such as ovarian cancer, endometrial cancer and testicular cancer.
The phase 1 trial is a dose escalation and expansion study evaluating the safety and efficacy of CTIM-76 among patients with CLDB6-positive advanced or metastatic cancer.
“With both CT-95 and CTIM-76 now dosed in initial patients, we are advancing our clinical pipeline and expanding our leadership in T cell engaging bispecific antibody therapies,” noted Lehr.
The dose escalation and expansion portions of the trial are evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of CTIM-76, and is expected to enroll up to 70 patients.
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