Solid TumorPhase 1NCT03680560
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
A Phase 1 study testing ACTR T Cell Product and Trastuzumab in people with Solid Tumor and HER-2 Protein Overexpression, run by Cogent Biosciences, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, HER-2 Protein Overexpression
- What is being tested?
- ACTR T Cell Product and Trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Mar 2019to 12 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Ohio State University
Columbus, Ohio, 43210
Baylor Scott & White Medical Center
Dallas, Texas, 75201
MD Anderson Cancer Center
Houston, Texas, 77030
Miami University Cancer Center
Miami, Florida, 33136
Sarah Cannon Research Institute/Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Yale Smilow Cancer Hospital
New Haven, Connecticut, 06511
About this study
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
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.
- Conditions
- Solid Tumor, HER-2 Protein Overexpression
- Being tested
- ACTR T Cell Product, Trastuzumab
- Keywords
- HER2, ACTR, ACTR087, ACTR707, T cell, T cell product, adoptive T cells, gene therapy, breast cancer, gastric cancer, gastro esophageal cancer, immunotherapy, solid tumor, adenoid cystic carcinoma
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms, Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTR T Cell ProductBiological
Autologous Antibody-Coupled T Cell Receptor (ACTR) T Cell Product (ACTR707 or ACTR087)
TrastuzumabDrug
monoclonal antibody targeting HER2
| Study group | Role | What they receive |
|---|---|---|
| ACTR T cell product in combination with trastuzumab | Experimental | Not described Receives: Biological: ACTR T Cell Product; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 42 days
Secondary outcomes (10)
Anti-tumor activity as measured by overall response rate (ORR) per iRECIST
Measured: 52 weeks
Anti-tumor activity as measured best overall response (BOR)
Measured: 52 weeks
Anti-tumor activity as measured by duration of response (DOR)
Measured: 52 weeks
Anti-tumor activity as measured by progression-free survival (PFS)
Measured: 52 weeks
Anti-tumor activity as measured by overall survival (OS)
Measured: 52 weeks
Assessment of persistence of ACTR as measured by flow cytometry
Measured: 52 weeks
Assessment of persistence of ACTR as measured by quantitative polymerase chain reaction (qPCR)
Measured: 52 weeks
Assessment of ACTR phenotype and function as measured by flow cytometry
Measured: 52 weeks
Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR T cell product administration
Levels of inflammatory markers, cytokines/chemokines in blood
Measured: 52 weeks
Trastuzumab pharmacokinetics (PK)
trastuzumab serum concentration, Area Under the Curve (AUC), trough levels
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start13 Mar 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: Business Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cogent Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glen Weiss, MD, Study director, Cogent Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680560
- Sponsor's protocol ID
- ATTCK-34-01
- Status last verified
- Mar 2020
- First submitted
- 14 Sep 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03680560
- Acronym / sponsor ID
- ATTCK-34-01
- Conditions
- Solid Tumor, HER-2 Protein Overexpression
- Keywords
- HER2, ACTR, ACTR087, ACTR707, T cell, T cell product, adoptive T cells, gene therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Reasons
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cogent Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTR T cell product in combination with trastuzumab | Experimental | Biological: ACTR T Cell Product, Drug: Trastuzumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTR T Cell ProductAutologous Antibody-Coupled T Cell Receptor (ACTR) T Cell Product (ACTR707 or ACTR087) | Biological | ACTR T cell product in combination with trastuzumab |
| Trastuzumabmonoclonal antibody targeting HER2 | Drug | ACTR T cell product in combination with trastuzumab |
Primary outcome
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
Time frame: 42 days
Determination of recommended phase 2 dose (RP2D) regimen
Time frame: 42 days
Review of DLTs, maximum tolerated dose (MTD), incidence and severity of AEs and clinically significant abnormalities of laboratory values
10 secondary outcomes
Anti-tumor activity as measured by overall response rate (ORR) per iRECIST
Time frame: 52 weeks
Anti-tumor activity as measured best overall response (BOR)
Time frame: 52 weeks
Anti-tumor activity as measured by duration of response (DOR)
Time frame: 52 weeks
Anti-tumor activity as measured by progression-free survival (PFS)
Time frame: 52 weeks
Anti-tumor activity as measured by overall survival (OS)
Time frame: 52 weeks
Assessment of persistence of ACTR as measured by flow cytometry
Time frame: 52 weeks
Assessment of persistence of ACTR as measured by quantitative polymerase chain reaction (qPCR)
Time frame: 52 weeks
Assessment of ACTR phenotype and function as measured by flow cytometry
Time frame: 52 weeks
Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR T cell product administration
Time frame: 52 weeks
Trastuzumab pharmacokinetics (PK)
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: Business Reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Sponsor WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen Weiss, MD study director
Cogent Biosciences, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACTR T Cell Product and Trastuzumab in people with Solid Tumor and HER-2 Protein Overexpression, run by Cogent Biosciences, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business Reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.