Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers

• Status: Terminated
• Trial end date: 2020-03-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cogent Biosciences, Inc.; Unum Therapeutics Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Trastuzumab

Criteria

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