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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-13

Study Completion Date

2020-03-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor HER-2 Protein Overexpression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACTR T cell product in combination with trastuzumab

Group Type EXPERIMENTAL

ACTR T Cell Product

Intervention Type BIOLOGICAL

Autologous Antibody-Coupled T Cell Receptor (ACTR) T Cell Product (ACTR707 or ACTR087)

Trastuzumab

Intervention Type DRUG

monoclonal antibody targeting HER2

Interventions

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ACTR T Cell Product

Autologous Antibody-Coupled T Cell Receptor (ACTR) T Cell Product (ACTR707 or ACTR087)

Intervention Type BIOLOGICAL

Trastuzumab

monoclonal antibody targeting HER2

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No