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TAC T-cells for the Treatment of HER2-positive Solid Tumors (TACTIC-2)

Primary Purpose

HER2 Positive Gastric Cancer, Metastatic HER2 Positive Gastroesophageal Junction Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TAC01-HER2
TAC01-HER2 plus pembrolizumab
Sponsored by
Triumvira Immunologics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2 Positive Gastric Cancer focused on measuring HER2 Positive Gastric Cancer, HER2 Positive gastroesophageal adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. A recent tumor sample to confirm HER2-protein expression on tumor cell surface.
  3. Relapsed or refractory disease after at least two prior lines of therapy.

    a. For breast cancer patients, both prior lines of therapy must include HER2 targeted agents.

  4. Measurable disease per RECIST Version 1.1.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Life expectancy of at least 12 weeks.
  7. Adequate organ function.

Exclusion Criteria:

  1. Active inflammatory or neurological disorder, autoimmune disease or infection
  2. Acute cardiovascular disease

Sites / Locations

  • Lurie Cancer Center - Northwestern UniversityRecruiting
  • University of Chicago Comprehensive Cancer CenterRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Rutgers Cancer Institute of New Jersey
  • Roswell Park Comprehensive Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • University of Cincinnati Cancer CenterRecruiting
  • Sidney Kimmel Cancer Center - Thomas Jefferson UniversityRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • Centre Hospitalier de l'Université de Montréal/Montreal Hospital University Center (CHUM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TAC01-HER2

TAC01-HER2 plus pembrolizumab

Arm Description

Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration.

Lymphodepletion followed by TAC01-HER2 as a single IV infusion, followed by pembrolizumab administration.

Outcomes

Primary Outcome Measures

Phase 1: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Document incidence of DLTs; Type, frequency, and severity of AEs (including clinically significant laboratory abnormalities).
Phase 2: Evaluate Overall Response Rate (ORR)
Defined as the percentage of treated subjects with a complete or partial response (CR or PR) as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1.
Phase 2: Evaluate Duration of Response (DoR)
Defined as time from first response to disease progression, end of study, start of another anticancer therapy, or death
Phase 2: Evaluate Overall survival (OS)
Defined as time from infusion to death from any cause
Phase 2: Evaluate Disease control rate (DCR)
Defined as the percentage of treated subjects with stable disease (SD), PR, and CR as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1.
Phase 2: Evaluate Progression-Free survival (PFS) or Time to progression (TTP)
Defined as time from infusion to disease progression or death from any cause

Secondary Outcome Measures

Phase 1: Determine MTD or RP2D for TAC01-HER2 monotherapy and pembrolizumab combination therapy
Document incidence of Dose-Limiting Toxicities.
Phase 1: Evaluate Overall Response Rate (ORR)
Defined as the percentage of treated subjects with a complete or partial response (CR or PR) as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1.
Phase 1: Evaluate Duration of Response (DoR)
Defined as time from first response to disease progression, end of study, start of another anticancer therapy, or death
Phase 1: Evaluate Overall survival (OS)
Defined as time from infusion to death from any cause
Phase 1: Evaluate Disease control rate (DCR)
Defined as the percentage of treated subjects with stable disease (SD), PR, and CR as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1.
Phase 1: Evaluate Progression-Free survival (PFS) or Time to progression (TTP)
Defined as time from infusion to disease progression or death from any cause
Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Document type, frequency, and severity of AEs (including clinically significant laboratory abnormalities).
Phase 1 and Phase 2: Cmax of TAC01-HER2 (pharmacokinetics; PK)
Defined as the maximum concentration of TAC T cells after infusion; assessed by vector copy number
Phase 1 and Phase 2: Tmax of TAC01-HER2 (PK)
Defined as the the first study day the Cmax is reached; assessed by vector copy number
Phase 1 and Phase 2: area under the concentration time curve (AUC) of TAC01-HER2 (PK)
Calculated using the trapezoid rule; assessed by vector copy number
Phase 1 and Phase 2: Duration of persistence of TAC T cells (PK)
Defined as the time between the first measurement of transgene above the limit of detection until the last observed quantifiable level of transgene; assessed by vector copy number
Phase 1 and Phase 2: Human anti-mouse antibody (HAMA) detection
Correlation of HAMA detection with TAC PK and subject response
Phase 1 and Phase 2: Cytokine level detection
Correlation with adverse events and subject response

Full Information

First Posted
January 20, 2021
Last Updated
September 13, 2023
Sponsor
Triumvira Immunologics, Inc.
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04727151
Brief Title
TAC T-cells for the Treatment of HER2-positive Solid Tumors
Acronym
TACTIC-2
Official Title
A Phase 1/2 Trial Investigating the Safety and Efficacy of Autologous TAC T Cell Monotherapy, and TAC T Cells in Combination With Pembrolizumab, in Relapsed HER2-Positive Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Triumvira Immunologics, Inc.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2). TAC directs T-cells to the targeted antigen (HER2), and once engaged with the target, activates them via the endogenous T cell receptor. This is an open-label, multicenter Phase 1/2 study that aims to establish safety, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-HER2 as a monotherapy, and in combination with pembrolizumab, in subjects with HER2 positive gastric and gastroesophageal adenocarcinoma.
Detailed Description
The TAC technology is a novel approach to modifying T cells, herein referred to as TAC T cells, and using them in the treatment of solid tumors. TAC T cells are produced through genetic engineering, incorporating TAC receptors into a patient's own T cells. This redirects these enhanced T cells to specific cancer antigens, and upon recognition, activates them through the natural signaling pathways of the endogenous TCR. In the TAC01-HER2 engineered T cell product; TAC T cells recognize the HER2 protein present on the surface of tumor cells, and eradicate them. Consequently, it is hypothesized TAC01-HER2 will be potentially safe and effective in treating patients with HER2+ solid tumors and provide a clinically meaningful therapeutic benefit in patient populations with high unmet medical need. This is a first-in-human study investigating TAC01-HER2 to evaluate the safety, MTD or RP2D, PK, and efficacy in subjects with HER2+ solid tumors who have been treated after at least 2 lines of prior therapy in Phase 1 and after at least 2 lines and no more than 4 lines of prior therapy in Phase 2. In Phase 1, escalating doses of TAC01-HER2 will be evaluated to identify the RP2D using the classic keyboard design method. The monotherapy arm will treat all subjects with HER2-positive solid tumors that meet the eligibility criteria (completed). The combination arm will treat all 2+ or 3+ HER2-positive subjects with gastric or gastroesophageal AC who meet the eligibility criteria. In Phase 2, dose expansion groups will further evaluate the efficacy, safety, and PK of the MTD or RP2D for TAC01-CLDN18.2 in subjects with gastric and esophageal adenocarcinoma. In Phase 2, a Simon 3-stage design will be used to enroll up to 36 subjects in Group A (monotherapy arm) and 34 subjects in Group B (combination arm). In summary: Phase I monotherapy arm: Dose escalation in any HER2-positive solid tumor (completed). Phase I combination therapy arm: Dose escalation in combination with pembrolizumab in 2+ or 3+ HER2-positive gastric and gastroesophageal adenocarcinoma Phase II: Dose expansion cohorts: 2+ or 3+ HER2-positive gastric or gastroesophageal adenocarcinoma treated with TAC01-HER2 as a monotherapy (Group A) or in combination with pembrolizumab (Group B).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 Positive Gastric Cancer, Metastatic HER2 Positive Gastroesophageal Junction Cancer
Keywords
HER2 Positive Gastric Cancer, HER2 Positive gastroesophageal adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
In Phase 1, escalating doses of TAC01-HER2 will be evaluated to identify the RP2D of the monotherapy arm and the combination arm using the classic keyboard design. In Phase 2, dose expansion groups will further evaluate the safety, efficacy, and PK of the MTD or RP2D for TAC01-HER2 as a monotherapy and in combination with pembrolizumab in subjects with gastric and gastroesophageal adenocarcinoma.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAC01-HER2
Arm Type
Experimental
Arm Description
Lymphodepletion followed by TAC01-HER2 as a single IV infusion, with a potential for a second dose administration.
Arm Title
TAC01-HER2 plus pembrolizumab
Arm Type
Experimental
Arm Description
Lymphodepletion followed by TAC01-HER2 as a single IV infusion, followed by pembrolizumab administration.
Intervention Type
Biological
Intervention Name(s)
TAC01-HER2
Intervention Description
TAC01-HER2 and: fludarabine and cyclophosphamide, or clofarabine and cyclophosphamide, or bendamustine, or cyclophosphamide
Intervention Type
Biological
Intervention Name(s)
TAC01-HER2 plus pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
TAC01-HER2 plus pembrolizumab and: fludarabine and cyclophosphamide, or clofarabine and cyclophosphamide, or bendamustine, or cyclophosphamide
Primary Outcome Measure Information:
Title
Phase 1: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Document incidence of DLTs; Type, frequency, and severity of AEs (including clinically significant laboratory abnormalities).
Time Frame
24 months
Title
Phase 2: Evaluate Overall Response Rate (ORR)
Description
Defined as the percentage of treated subjects with a complete or partial response (CR or PR) as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1.
Time Frame
24 months
Title
Phase 2: Evaluate Duration of Response (DoR)
Description
Defined as time from first response to disease progression, end of study, start of another anticancer therapy, or death
Time Frame
24 months
Title
Phase 2: Evaluate Overall survival (OS)
Description
Defined as time from infusion to death from any cause
Time Frame
24 months
Title
Phase 2: Evaluate Disease control rate (DCR)
Description
Defined as the percentage of treated subjects with stable disease (SD), PR, and CR as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1.
Time Frame
24 months
Title
Phase 2: Evaluate Progression-Free survival (PFS) or Time to progression (TTP)
Description
Defined as time from infusion to disease progression or death from any cause
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Phase 1: Determine MTD or RP2D for TAC01-HER2 monotherapy and pembrolizumab combination therapy
Description
Document incidence of Dose-Limiting Toxicities.
Time Frame
Up to 29 Days Post TAC01-HER2 infusion
Title
Phase 1: Evaluate Overall Response Rate (ORR)
Description
Defined as the percentage of treated subjects with a complete or partial response (CR or PR) as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1.
Time Frame
24 months
Title
Phase 1: Evaluate Duration of Response (DoR)
Description
Defined as time from first response to disease progression, end of study, start of another anticancer therapy, or death
Time Frame
24 months
Title
Phase 1: Evaluate Overall survival (OS)
Description
Defined as time from infusion to death from any cause
Time Frame
24 months
Title
Phase 1: Evaluate Disease control rate (DCR)
Description
Defined as the percentage of treated subjects with stable disease (SD), PR, and CR as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1.
Time Frame
24 months
Title
Phase 1: Evaluate Progression-Free survival (PFS) or Time to progression (TTP)
Description
Defined as time from infusion to disease progression or death from any cause
Time Frame
24 months
Title
Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Document type, frequency, and severity of AEs (including clinically significant laboratory abnormalities).
Time Frame
24 Months
Title
Phase 1 and Phase 2: Cmax of TAC01-HER2 (pharmacokinetics; PK)
Description
Defined as the maximum concentration of TAC T cells after infusion; assessed by vector copy number
Time Frame
24 Months
Title
Phase 1 and Phase 2: Tmax of TAC01-HER2 (PK)
Description
Defined as the the first study day the Cmax is reached; assessed by vector copy number
Time Frame
24 Months
Title
Phase 1 and Phase 2: area under the concentration time curve (AUC) of TAC01-HER2 (PK)
Description
Calculated using the trapezoid rule; assessed by vector copy number
Time Frame
24 Months
Title
Phase 1 and Phase 2: Duration of persistence of TAC T cells (PK)
Description
Defined as the time between the first measurement of transgene above the limit of detection until the last observed quantifiable level of transgene; assessed by vector copy number
Time Frame
24 Months
Title
Phase 1 and Phase 2: Human anti-mouse antibody (HAMA) detection
Description
Correlation of HAMA detection with TAC PK and subject response
Time Frame
Up to 29 Days Post TAC01-HER2 infusion
Title
Phase 1 and Phase 2: Cytokine level detection
Description
Correlation with adverse events and subject response
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent. Age ≥ 18 years at the time of informed consent. For Phase 1 and Phase 2: Phase 1 monotherapy (completed): HER2 1+, 2+, 3+ by IHC by central laboratory confirmation Phase 1 combination therapy and Phase 2: HER2 2+, 3+ by IHC and FISH by central laboratory confirmation Histologically confirmed advanced, metastatic, unresectable solid tumors (regardless of PD-L1 expression levels; Phase 1 monotherapy) and histologically confirmed advanced, metastatic, unresectable gastric or esophageal adenocarcinoma (regardless of PD-L1 expression levels for Phase 1 combination therapy and Phase 2) after at least 2 prior lines of therapy (Phase 1) or after at least 2 and no more than 4 prior lines of therapy (Phase 2). HER2+ incurable malignancies for which no standard-of-care HER2 targeted therapy exists may be enrolled regardless of the number of prior treatment lines, as long as in the opinion of the investigator the subject would be unlikely to tolerate or derive clinically meaningful benefit from other available treatment options. For breast cancer subjects, both prior lines of therapy must have included HER2-targeted agents per current standard-of-care. Subjects with solid tumors with genetic alterations and mutations (such as BRAF, BRCA, EGFR mutations, and ALK translocation) where approved targeted therapies were available to their specific cancers must have been previously treated with such approved therapies or refused such approved targeted therapy for their cancers prior to enrollment, or in the opinion of the investigator would be unlikely to tolerate or derive clinically meaningful benefit from these standard-of-care therapies. Measurable disease per RECIST 1.1 at time of enrollment. ECOG performance status of 0 or 1 at Screening. Life expectancy of at least 12 weeks. Adequate organ and bone marrow reserve function. Recovery to Grade ≤1 or Baseline for any toxicities due to previous therapy. Adequate vascular access for leukapheresis. Negative pregnancy test and use of highly effective contraception. Undetectable HBV viral load. HCV viral load is undetectable. Exclusion Criteria: Intolerant to any component of TAC01-HER2. Prior treatment with any of the following: Adoptive cell transfer of any kind, including CAR T cells Gene therapy Investigational medicinal product within 5 half-lives or 21 days prior to leukapheresis, whichever is shorter. Receipt of a live or live-attenuated vaccine within 30 days prior to study treatment. Monoclonal antibody (mAb), including PD-1 and PD-L1, therapies within 21 days prior to leukapheresis. Radiation within 28 days prior to enrollment. Palliative radiation is allowed up to 14 days prior to enrollment if non-irradiated lesions are present. Chemotherapy or targeted small molecule therapy within 14 days prior to leukapheresis, or within 7 days prior to leukapheresis for erlotinib, gefitinib, afatinib, or crizotinib. Colony stimulating factors, including granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, and other hematopoietic cytokines, within 14 days prior to leukapheresis. Immunosuppressive medication within 14 days or corticosteroid treatment < 72 hours prior to enrollment. History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. (Brain metastasis - non-progressive or previously treated and currently stable - are permitted.) Active inflammatory neurological disorders (e.g., Guillain-Barre Syndrome, amyotrophic lateral sclerosis, multiple sclerosis). Active autoimmune disease (e.g., lupus, rheumatoid arthritis, Sjogren's syndrome) requiring systemic disease modifying agents in the past 2 years. Active or uncontrolled hepatitis B or C (HCV ribonucleic acid [RNA] positive) infection or any history of or active human immunodeficiency virus (HIV) infection. Uncontrolled, acute, or life-threatening bacterial, viral, or fungal infection. Subjects with ongoing use of prophylactic antibiotics, antifungals, or antivirals are eligible if no evidence of active infection. Class III or IV heart failure (as defined by the New York Heart Association - NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease within 6 months prior to Screening. Cardiac arrhythmia not controlled by medical management. Clinically significant thrombotic events within 6 months prior to leukapheresis and/or inability to stop anti-coagulation for at least 2 weeks prior to TAC01-HER2 infusion. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Pregnant or lactating. As determined by the Investigator, any uncontrolled medical, psychological, familial, sociological, or geographical condition(s) that do(es) not permit compliance with the protocol. Participation in or has participated in a study using an investigational device within 4 weeks prior to study treatment.. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate, in the opinion of the treating investigator. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. Combination Arm Only Specific Exclusions: Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE). Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of trial treatment. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. Has history of an allogeneic stem cell transplant or a solid organ transplant. Has a history of radiation pneumonitis. (Note: Cannot receive prior radiotherapy within 2 weeks of start of pembrolizumab. Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation [≤2 weeks of radiotherapy] to non-CNS disease).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kara Moss
Phone
(512) 646-4516
Email
patient.info@triumvira.com
Facility Information:
Facility Name
Lurie Cancer Center - Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Joslin
Phone
312-695-1102
Email
ben.joslin@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Devalingam Mahalingham, MD
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooke Pieke, MS
Phone
773-834-9636
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Andrea Fadel, BSN, RN
Phone
773-702-4779
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Daniel Olson, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Weiss
Phone
617-632-4582
Email
jordan_weiss@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Schlechter, MD
Facility Name
Rutgers Cancer Institute of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Completed
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paige Burkard
Phone
716-845-1127
Email
Paige.burkard@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Anuradha Krishnamurthy, MD
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
646-608-2091
Email
cart@mskcc.org
First Name & Middle Initial & Last Name & Degree
Geoffrey Ku, MD
Facility Name
University of Cincinnati Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US Cancer Center
Phone
513-584-7698
First Name & Middle Initial & Last Name & Degree
Davendra Sohal, MD
Facility Name
Sidney Kimmel Cancer Center - Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natisha Muhammad
Phone
215-955-5769
Email
Natisha.Muhammad@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Babar Bashir, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ecaterina Dumbrava, MD
Phone
713-792-3934
Email
eeileana@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ecaternia Dumbrava, MD
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heaven Gumapac
Phone
416.946.4501
Ext
4501
Email
heaven.gumapac2@uhn.ca
First Name & Middle Initial & Last Name & Degree
Guillaume Cheung
Phone
416.946.4501
Ext
4748
Email
guillaume.cheung@uhn.ca
First Name & Middle Initial & Last Name & Degree
Samuel Saibil, MD
Facility Name
Centre Hospitalier de l'Université de Montréal/Montreal Hospital University Center (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeline Hamon
Phone
514-890-8000
Ext
30737
Email
adeline.hamon.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Simon Turcotte, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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TAC T-cells for the Treatment of HER2-positive Solid Tumors

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