Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Phase 1a Dose Escalation: Participants with ovarian epithelial tumors, primary peritoneal or fallopian tube cancer (PROC), epithelioid mesothelioma, lung adenocarcinoma, pancreatic adenocarcinoma, colorectal cancer, cholangiocarcinoma, and gastric/GEJ adenocarcinomas will be enrolled in one of approximately 9 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 dose expansion cohorts.
Participants will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle.
Phase 1b Dose Expansion: The RDE(s) of CT-95 determined in Phase 1a will be evaluated in 2-4 indication-specific expansion cohorts of up to 20 subjects each (i.e. up to 80 participants total). Different indications, dose levels, and/or schedules may be explored. The expansion doses and/or dosing schedules for Phase 1b will be determined by Sponsor in conjunction with SRC based upon all available safety, PK, PD, biomarker, and preliminary efficacy data from Phase 1a.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-95 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of first dose of CT-95 until 28 days following the first dose. |
| 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. | From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Context Clinical Development | Contact | 267-225-7416 | cntx-ct95-101@contexttherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Karen Chagin, MD | Context Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Context Investigational Site | Recruiting | Denver | Colorado | 80218 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Evaluate Progression-free Survival [Anti-tumor Activity] |
PFS will be summarized using RECIST 1.1 (and mRECIST for patients with mesothelioma) for CT-95. |
| 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. |
| Evaluate Overall Survival [Survival] | Overall survival will be summarized for CT-95. | From the time of the first dose of CT-95 until approximately two years post-first dose. |
| Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics] | Serum concentrations of CT-95 analyzed as a function of time relative to dosing will be calculated. | From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first. |
| Evaluate the Area Under the Curve (AUC) [Pharmacokinetics] | The AUC of CT-95 analyzed as a function of time relative to dosing will be calculated. | From date of first dose of CT-95 for 5 months or treatment discontinuation, whichever comes first. |
| Evaluate Anti-Drug Antibodies [Immunogenicity] | Incidence and titer of ADAs will be evaluated. | From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first. |
| Context Investigational Site | Recruiting | Chicago | Illinois | 60637 | United States |
|
| Context Investigational Site | Recruiting | Grand Rapids | Michigan | 49546 | United States |
|
| Context Investigational Site | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Context Investigational Site | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| Context Investigational Site | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| Context Investigational Site | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Context Investigational Site | Recruiting | San Antonio | Texas | 78229 | United States |
|
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D000086002 | Mesothelioma, Malignant |
| D009362 | Neoplasm Metastasis |
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided