Solid Tumor Clinical Trial
Official title:
A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies
Verified date | March 2020 |
Source | Unum Therapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with HER2-positive advanced malignancies.
Status | Terminated |
Enrollment | 6 |
Est. completion date | March 12, 2020 |
Est. primary completion date | March 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Signed written informed consent obtained prior to study procedures - Histologically-confirmed Her2 positive advanced solid tumor malignancy with documented disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer - Subjects must have previously received adequate standard therapy for treatment of their malignancy - For those with metastatic breast cancer, must have received HER2-directed therapy including trastuzumab, pertuzumab and ado-trastuzumab in any breast cancer disease setting - For those with advanced gastric cancer, adequate prior treatment with HER2-directed chemotherapy is required - At least 1 measurable lesion by iRECIST - Able to provide fresh tumor biopsy or archived block specimen taken since time of most recent anti-HER2 mAb-directed therapy - ECOG of 0 or 1 - Life expectancy = 6 months - LVEF = 50% by MUGA or ECHO - Absolute neutrophil (ANC) count = 1500/ µL - Platelet count = 100,000/µL - Hemoglobin = 9g/dL - Estimated GFR >30mL/min/1.73m2 Exclusion Criteria: - glioblastoma multiforme or other primary CNS tumors are excluded - clinically significant cardiac disease - clinically significant active infection - clinical history, prior diagnosis, or overt evidence of autoimmune disease - current use of more than 5mg/day of prednisone (or an equivalent glucocorticoid) - Prior treatment as follows: - prior cumulative doxorubicin dose greater than or equal to 300 mg/m^2 or equivalent - chemotherapy within 2 weeks of enrollment - external beam radiation within 2 weeks of enrollment (28 days if CNS-directed therapy) - any monoclonal antibody (mAb) or other protein therapeutic containing Fc-domains within 4 weeks of enrollment - pertuzumab within 4 months of enrollment - Experimental agents within 3 half-lives or 28 days prior to enrollment, whichever is shorter - allogeneic hematopoietic stem cell transplant (HSCT) - prior infusion of a genetically modified therapy - Pregnant or breastfeeding |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
United States | Baylor Scott & White Medical Center | Dallas | Texas |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Miami University Cancer Center | Miami | Florida |
United States | Sarah Cannon Research Institute/Tennessee Oncology, PLLC | Nashville | Tennessee |
United States | Yale Smilow Cancer Hospital | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Unum Therapeutics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of ACTR T cell product with trastuzumab as assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of adverse events (AEs) and clinically significant abnormalities of laboratory values | 42 days | ||
Primary | Determination of recommended phase 2 dose (RP2D) regimen | Review of DLTs, maximum tolerated dose (MTD), incidence and severity of AEs and clinically significant abnormalities of laboratory values | 42 days | |
Secondary | Anti-tumor activity as measured by overall response rate (ORR) per iRECIST | 52 weeks | ||
Secondary | Anti-tumor activity as measured best overall response (BOR) | 52 weeks | ||
Secondary | Anti-tumor activity as measured by duration of response (DOR) | 52 weeks | ||
Secondary | Anti-tumor activity as measured by progression-free survival (PFS) | 52 weeks | ||
Secondary | Anti-tumor activity as measured by overall survival (OS) | 52 weeks | ||
Secondary | Assessment of persistence of ACTR as measured by flow cytometry | 52 weeks | ||
Secondary | Assessment of persistence of ACTR as measured by quantitative polymerase chain reaction (qPCR) | 52 weeks | ||
Secondary | Assessment of ACTR phenotype and function as measured by flow cytometry | 52 weeks | ||
Secondary | Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR T cell product administration | Levels of inflammatory markers, cytokines/chemokines in blood | 52 weeks | |
Secondary | Trastuzumab pharmacokinetics (PK) | trastuzumab serum concentration, Area Under the Curve (AUC), trough levels | 52 weeks |
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