Study Stopped
Business Reasons
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
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
1 other identifier
interventional
6
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2019
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2018
CompletedFirst Posted
Study publicly available on registry
September 21, 2018
CompletedStudy Start
First participant enrolled
March 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2020
CompletedMarch 31, 2020
March 1, 2020
1 year
September 14, 2018
March 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (10)
Anti-tumor activity as measured by overall response rate (ORR) per iRECIST
52 weeks
Anti-tumor activity as measured best overall response (BOR)
52 weeks
Anti-tumor activity as measured by duration of response (DOR)
52 weeks
Anti-tumor activity as measured by progression-free survival (PFS)
52 weeks
Anti-tumor activity as measured by overall survival (OS)
52 weeks
- +5 more secondary outcomes
Study Arms (1)
ACTR T cell product in combination with trastuzumab
EXPERIMENTALInterventions
Autologous Antibody-Coupled T Cell Receptor (ACTR) T Cell Product (ACTR707 or ACTR087)
monoclonal antibody targeting HER2
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Yale Smilow Cancer Hospital
New Haven, Connecticut, 06511, United States
Miami University Cancer Center
Miami, Florida, 33136, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Sarah Cannon Research Institute/Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Baylor Scott & White Medical Center
Dallas, Texas, 75201, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Glen Weiss, MD
Cogent Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2018
First Posted
September 21, 2018
Study Start
March 13, 2019
Primary Completion
March 12, 2020
Study Completion
March 12, 2020
Last Updated
March 31, 2020
Record last verified: 2020-03