Adenocarcinoma of the Ovary, Fallopian Tube Adenocarcinoma, Peritoneal Mesothelioma, Primary Peritoneal Carcinoma
Conditions
Keywords
platinum resistant, high grade serous adenocarcinoma, recurrence after chemotherapy, intraperitoneal
Brief summary
This is a phase 1 dose escalation study to characterize the feasibility, safety and tolerability of MCY-M11 when administered as an intraperitoneal (IP) infusion for 3 weekly doses for women with platinum resistant high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube, and subjects with peritoneal mesothelioma with recurrence after prior chemotherapy. The study will also assess multiple cycles of treatment and adding preconditioning with cyclophosphamide.
Interventions
BIOLOGICALMCY-M11
Intraperitoneal administration
DRUGCyclophosphamide
Intravenous administration for preconditioning
Sponsors
CTI Clinical Trial and Consulting Services
MaxCyte, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be able to undergo peripheral blood leukapheresis; have successful placement of an intraperitoneal catheter * Be diagnosed with one of the following: metastatic or unresectable high grade serous adenocarcinoma involving the ovary, primary peritoneum, or fallopian tube with peritoneal involvement, not including mixed histologies, OR unresectable epithelioid or biphasic peritoneal mesothelioma * Be at least 4 weeks from previous anti-cancer therapy * Have a life expectancy of greater than 3 months.
Exclusion criteria
* Females who are pregnant, trying to become pregnant, or breastfeeding * Diagnosis of HIV or chronic active Hepatitis B or C * Symptomatic or uncontrolled brain metastases requiring current treatment * Impaired cardiac function or clinically significant cardiac disease * Lack of recovery of prior mild adverse events due to earlier therapies * Active infection * Another previous or current malignancy within the last 3 years, with exceptions * Concomitant chronic use of steroids or NSAIDs * Concomitant use of complementary or alternative medication or therapy * Autoimmune disease or inflammatory disease within previous 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events as assessed by CTCAE v.5.0 | 6 weeks | number and severity of adverse events according to NCI CTCAE v.5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Evaluation Criteria in Solid Tumors (RECIST) | from first MCY-M11 dosing to first documented progression, assessed up to 24 months | tumor response scored by RECIST criteria |
| Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | from first MCY-M11 dosing to first documented progression, assessed up tp 24 months | tumor response scored by irRECIST criteria |
Countries
United States
Outcome results
None listed