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CT-95 in Advanced Cancers Associated With Mesothelin Expression

ConditionsMesothelin-Expressing TumorsEpithelial Ovarian CancerMalignant Pleural Mesothelioma, AdvancedMalignant Peritoneal Mesothelioma, AdvancedPancreatic Adenocarcinoma Advanced or MetastaticLung Adenocarcinoma MetastaticCholangiocarcinoma AdvancedCholangiocarcinoma Non-resectableMesothelin-expressing Advanced CancersMesothelin-positive Advanced Malignant Solid TumorsColorectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorContext Therapeutics Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: CT-95Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determine the MTD or RD of CT-95 [Safety and Tolerability]

The frequency of dose-limiting toxicities (DLTs) will be analyzed along with safety and tolerability measures to determine the MTD or RD of CT-95.

Time frame
From date of first dose of CT-95 until 28 days following the first dose.
2

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

The frequency and severity of adverse events, serious adverse events, and adverse events of special interest will be analyzed.

Time frame
From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.

Secondary outcomes

1

Evaluate Response Rates [Anti-tumor Activity]

Overall response rates will be calculated using RECIST 1.1 (and mRECIST for patients with mesothelioma) for CT-95.

Time frame
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
2

Evaluate Progression-free Survival [Anti-tumor Activity]

PFS will be summarized using RECIST 1.1 (and mRECIST for patients with mesothelioma) for CT-95.

Time frame
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.
3

Evaluate Overall Survival [Survival]

Overall survival will be summarized for CT-95.

Time frame
From the time of the first dose of CT-95 until approximately two years post-first dose.
4

Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics]

Serum concentrations of CT-95 analyzed as a function of time relative to dosing will be calculated.

Time frame
From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Context Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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