A Phase I Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SGN-MesoC2 in Subjects With Advanced Solid Tumors
Study Identifier:
C5991001/SGNMESOC2-001
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruitment Complete
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Study Summary
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SGN-MesoC2 in Subjects With Advanced Solid Tumors
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
18+ years
Study Drug
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Study Status
Indicates the current recruitment status or the expanded access status
Recruitment Complete
Requirements information
Inclusion criteria
- Aged 18 years or older.
- Histologically- or cytologically-confirmed metastatic or locally advanced unresectable platinum-resistant ovarian cancer, NSCLC, pancreatic ductal adenocarcinoma, endometrial cancer, colorectal cancer, or mesothelioma, who have relapsed or progressed following standard therapies, or for which no standard therapies are available.
- An Eastern Cooperative Oncology Group performance status score of 0 or 1.
- At least 1 measurable lesion at baseline based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- Archival tumor tissue or a fresh tumor biopsy during the screening period.
- Adequate hepatic, renal and bone marrow function.
- Participants must not have received more than 2 lines of cytotoxic systemic therapy in the metastatic setting (Parts B and C only).
- Key inclusion criteria are histologically or cytologically confirmed metastatic or locally advanced mesothelioma, PROC, PDAC, NSCLC, EC, or CRC who have relapsed or progressed following standard therapies; aged ≥18 years; ECOG performance status score of 0 or 1; and available archival tumor tissue (a fresh biopsy is required if unavailable).
- Eligible patients included in this study will meet the following criteria:
- Aged 18 years or older.
- Histologically- or cytologically-confirmed metastatic or locally advanced unresectable platinum-resistant ovarian cancer, NSCLC, pancreatic
- ductal adenocarcinoma, endometrial cancer, colorectal cancer, or mesothelioma, who have relapsed or progressed following standard therapies,
- or for which no standard therapies are available.
- An Eastern Cooperative Oncology Group performance status score of O or 1.
- At least 1 measurable lesion at baseline based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST vl.l).
- Archival tumor tissue or a fresh tumor biopsy during the screening period.
- Adequate hepatic, renal and bone marrow function.
- Participants must not have received more than 2 lines of cytotoxic systemic therapy in the metastatic setting (Parts B and C only).
Exclusion criteria
- Previously received or currently receiving any systemic anticancer therapy or focal radiotherapy within 4 weeks prior to the first dose of MesoC2 or within 2 weeks prior to the first dose of MesoC2 if the underlying disease had progressed on treatment.
- Prior anti-MSLN antibody or MSLN-directed ADC (Part C only).
- Unresolved toxicities from prior therapy greater than NCI CTCAE v5.0 grade 1 at the time of study treatment (except alopecia).
- Inadequate hepatic dysfunction, renal function, or hematologic abnormalities.
- Previously untreated brain metastases. Participants who received radiation or surgery for brain metastases are eligible if therapy was completed at least 4 weeks prior to study treatment initiation, and there was no evidence of central nervous system progression nor requirements for chronic corticosteroid therapy
- History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- Known to be positive for human immunodeficiency virus (HIV). Participants with severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, or active bleeding diatheses.
- Participants with medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at screening period.
- Previously untreated brain metastases. Participants who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 4 weeks prior to initiation of study treatment, there is no evidence of central nervous system (CNS) disease progression, and there is no requirement for chronic corticosteroid therapy. Leptomeningeal metastases or spinal cord compression due to disease.
- Key exclusion criteria include prior or current treatment with systemic anticancer therapy or focal radiotherapy within 4 weeks prior to first dose of MesoC2, prior anti-MSLN therapies, and any unresolved toxicities from prior therapy greater than G1 at the time of starting study treatment, except alopecia.
- Patients will be excluded from the study if they meet the following criteria:
- Previously received or currently receiving any systemic anticancer therapy or focal radiotherapy within 4 weeks prior to the first dose of MesoC2
- or within 2 weeks prior to the first dose Of MesoC2 if the underlying disease had progressed on treatment.
- Prior anti-MSLN antibody or MSLN-directed ADC (Part C only).
- Unresolved toxicities from prior therapy greater than NCI CTCAE v5.O grade 1 at the time of study treatment (except alopecia).
- Inadequate hepatic dysfunction, renal function, or hematologic abnormalities.
- Previously untreated brain metastases. Participants who received radiation or surgery for brain metastases are eligible if therapy was completed
- at least 4 weeks prior to study treatment initiation, and there was no evidence of central nervous system progression nor requirements for chronic
- corticosteroid therapy.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
William McKean
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Bowel (Colorectal)
Mesothelioma
Endometrial
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Amita Patnaik
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Bowel (Colorectal)
Mesothelioma
Endometrial