Metastatic Breast CancerPhase 1/2Breast-47NCT03272334
Her2-BATS and Pembrolizumab in Metastatic Breast Cancer
A Phase 1/2 study testing HER2 BATs with Pembrolizumab in people with Metastatic Breast Cancer, run by University of Virginia at 1 site in United States.
Trial summary
This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- HER2 BATs with Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2017to Jan 2031
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast cancer (infiltrating ductal or lobular breast carcinoma) with evidence of measurable metastatic disease. Metastatic disease must be biopsy proven.
- Since histologic type, lymphatic permeation, blood vessel invasion, and degree of anaplasia may be prognostic variables, appropriate slides of the primary lesion will be requested for future review. HER2, estrogen, and progesterone receptor positivity will be recorded.
- Measurable lesion. Patients are required to have at least one measurable non-bone lesion ≥10 mm that has not been irradiated.
- Measurable metastatic disease documented by radiograph, CT scan, PET/CT, MRI, or physical exam is required. Each subject will be required to have at least one measurable lesion that has not been irradiated with a minimum size in at least one diameter of ≥ 10 mm for liver lesions, lung, skin, and ≥ 15 mm lymph node metastases. Biopsy of recurrent site(s) is not required.
- Patients must have HER2 status determined by FISH or IHC. HER2 status of positive or negative are both eligible for the study.
- In order to be eligible for participation in this trial, the patient must also:
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- Be female ≥ 18 years of age
- Be willing and able to provide written informed consent for the trial.
- Have a performance status (PS) ECOG 0-1
- Have a life expectancy ≥ 3 months
- Be eligible for apheresis, as determined by the Stem Cell Transplant team
- Demonstrate adequate organ function as defined below, all screening labs should be performed within 10 days prior to apheresis.
- Absolute lymphocyte count ≥ 500/mm3 Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥ 100,000 / mcL Hemoglobin ≥ 9 g/dL (or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) BUN ≤ 1.5 X upper limit of normal (ULN) Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Serum total bilirubin ≤ 1.5 X ULN OR AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Albumin >2.5 mg/dL International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy Activated Partial Thromboplastin Time (aPTT) as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Female patients of childbearing potential should have a negative urine or serum pregnancy test at screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 4.5.2, for the course of the study through 120 days after the last dose of study medication.
- Patients must have had two or more lines of prior therapy (chemo or hormonal) in the metastatic setting
Who cannot join
- The patient must be excluded from participating in the trial if the subject:
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to leukapheresis.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to PBZ or any of its excipients.
- Lack of recovery (i.e., ≤ Grade 1 or baseline prior to last line of cancer therapy) from non-laboratory adverse events except ≤ Grade 2 neuropathy
- Has history of another malignancy within the past 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
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- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to leukapheresis. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or known history of Hepatitis B (e.g., HBsAg reactive) or Hepatitis C antibody is detected. Note: Patients may be eligible if HCV antibody is detected as long as HCV viral load is undetectable following an FDA approved treatment regimen
- Has received a live vaccine within 30 days of apheresis. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Has a history of significant cardiac disease, including:
- History of a recent myocardial infarction (within one year), a past myocardial infarction (more than one year ago) along with current coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF < 45% by MUGA or ECHO).
- Current history of angina/coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF < 45% by MUGA or ECHO)
- Clinical evidence of congestive heart failure requiring medical management (irrespective of ECHO results).
- Pt may be excluded if, in the opinion of the PI and investigator team, the pt is not capable of being compliant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer
This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an additional 12 patients will be treated at the selected dose to further evaluate the safety and preliminary efficacy.
Study treatment includes a combination of 8 infusions of BATs using a previously established schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8 infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions.
Read the detailed description
Once subjects are determined eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. Depending on arm/schedule, about 4-5 weeks later, study treatment will begin. For HER2 BATs, the white blood cells, specifically T cells, are then mixed with two proteins - OKT3 and IL-2 -- which activates the cells to multiply. After approximately 14 days in culture, the activated T cells are coated with OKT3 and trastuzumab/Herceptin (HER2Bi), and washed to remove excess Herceptin in order to produce bispecific antibody armed T cells (BATs). Cells are then frozen and stored until scheduled to be infused.
Follow-up appointment schedule will include clinic visits 2 weeks, 1 month, 3 months, and 6 months after the last dose of Pembrolizumab.
- Conditions
- Metastatic Breast Cancer
- Being tested
- HER2 BATs with Pembrolizumab
- Keywords
- Metastatic Breast Cancer, Adoptive Cell Therapy, Armed Activated T-cells, Bispecific Antibodies, Immunotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2 BATs with PembrolizumabDrug
8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| Schedule #1 | Experimental | At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4. Receives: Drug: HER2 BATs with Pembrolizumab |
| Schedule #2 | Experimental | At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7. Receives: Drug: HER2 BATs with Pembrolizumab |
| Schedule #3 | Experimental | At approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. Receives: Drug: HER2 BATs with Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (Escalation and Expansion Cohorts)
Maximum tolerated dose will be based on number of dose limiting toxicities in each schedule/arm
Measured: From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks.
Secondary outcomes (7)
Dose Limiting Toxicities on the Selected Arm in the Expansion Cohort
Dose Limiting toxicities on the arm selected based on the dose/schedule selection part of the study.
Measured: From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks.
Objective Response Rate
The percentage of subjects with a response of complete response (CR) or partial response (PR) per immune related response criteria (irRC)
Measured: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment (about 8.5 months after starting study treatment). Imaging will then be performed according to standard of care.
Overall Survival
Time from enrollment until death from any cause
Measured: Every 3 months following last study visit until death
Progression-Free Survival
Time from enrollment to time of first progression after enrollment (days)
Measured: Checked from enrollment through first progression, about every 3 months, through death or end of study
Immune Response to Treatment in Blood
Sequential monitoring of phenotype, IFN-γ EliSpots, anti-breast cancer cytotoxicity of peripheral blood mononuclear cells (PBMC) directed at breast cancer cell lines, Th1/Th2 serum cytokine patterns, and anti-breast cancer antibodies in the serum during the "vaccinate and consolidate" process
Measured: Blood will be collected about 5 weeks before any treatment, just before first HER2 BATs infusion, before HER2 BATs #5, before HER2 BATs #8, and 2 weeks, 1 month, 3 months, and 6 months after last Pembrolizumab
Disease Control Rate
The percentage of subjects who achieve complete response, partial response and stable disease following treatment.
Measured: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment. Imaging will then be performed according to standard of care.
Duration of Response
The time from documentation of tumor response to disease progression.
Measured: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment. Imaging will then be performed according to standard of care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start29 Dec 2017
- Primary completion30 Nov 2024
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pembrolizumab administered in combination with HER2 Bispecific Antibody Armed Activated T-Cell (BATs) infusions
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Patrick Dillon, MD, University of Virginia
- Investigators
- Patrick Dillon, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272334
- Sponsor's protocol ID
- 19406
- Acronym
- Breast-47
- Status last verified
- Feb 2026
- First submitted
- 28 Aug 2017
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lum LG, Thakur A, Al-Kadhimi Z, Colvin GA, Cummings FJ, Legare RD, Dizon DS, Kouttab N, Maizel A, Colaiace W, Liu Q, Rathore R. Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial. Clin Cancer Res. 2015 May 15;21(10):2305-14. doi: 10.1158/1078-0432.CCR-14-2280. Epub 2015 Feb 16.
PubMed 25688159Vaishampayan U, Thakur A, Rathore R, Kouttab N, Lum LG. Phase I Study of Anti-CD3 x Anti-Her2 Bispecific Antibody in Metastatic Castrate Resistant Prostate Cancer Patients. Prostate Cancer. 2015;2015:285193. doi: 10.1155/2015/285193. Epub 2015 Feb 23.
PubMed 25802762
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03272334
- Acronym / sponsor ID
- Breast-47 / 19406
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Adoptive Cell Therapy, Armed Activated T-cells, Bispecific Antibodies, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- Jan 2031 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an additional 12 patients will be treated at the selected dose to further evaluate the safety and preliminary efficacy.
Study treatment includes a combination of 8 infusions of BATs using a previously established schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8 infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions.
Detailed description
Once subjects are determined eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. Depending on arm/schedule, about 4-5 weeks later, study treatment will begin. For HER2 BATs, the white blood cells, specifically T cells, are then mixed with two proteins - OKT3 and IL-2 -- which activates the cells to multiply. After approximately 14 days in culture, the activated T cells are coated with OKT3 and trastuzumab/Herceptin (HER2Bi), and washed to remove excess Herceptin in order to produce bispecific antibody armed T cells (BATs). Cells are then frozen and stored until scheduled to be infused.
Follow-up appointment schedule will include clinic visits 2 weeks, 1 month, 3 months, and 6 months after the last dose of Pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pembrolizumab administered in combination with HER2 Bispecific Antibody Armed Activated T-Cell (BATs) infusions
| Arm | Type | Receives |
|---|---|---|
| Schedule #1 | Experimental | Drug: HER2 BATs with PembrolizumabAt approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 1 infusion of Pembrolizumab in week #7. No interventions within weeks #3 and 4. |
| Schedule #2 | Experimental | Drug: HER2 BATs with PembrolizumabAt approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 2 infusions of Pembrolizumab; the first given within weeks #3 - 4 and the second in week #7. |
| Schedule #3 | Experimental | Drug: HER2 BATs with PembrolizumabAt approximately 4 weeks following leukapheresis, 8 infusions of HER2 BATs are given twice weekly in weeks #1, #2, #5, and #6 plus 3 infusions of pembrolizumab; the first given one week prior to first BATs infusion, the second is given within weeks #3 - 4, and the third at week #7. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed breast cancer (infiltrating ductal or lobular breast carcinoma) with evidence of measurable metastatic disease. Metastatic disease must be biopsy proven.
- Measurable lesion. Patients are required to have at least one measurable non-bone lesion ≥10 mm that has not been irradiated.
- Patients must have HER2 status determined by FISH or IHC. HER2 status of positive or negative are both eligible for the study.
- Be female ≥ 18 years of age
- Be willing and able to provide written informed consent for the trial.
Key exclusion criteria (20 listed)
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to leukapheresis.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to PBZ or any of its excipients.
- Lack of recovery (i.e., ≤ Grade 1 or baseline prior to last line of cancer therapy) from non-laboratory adverse events except ≤ Grade 2 neuropathy
- Has history of another malignancy within the past 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
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 |
|---|---|---|
| HER2 BATs with Pembrolizumab8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab | Drug | Schedule #1, Schedule #2, Schedule #3 |
Primary outcome
Dose Limiting Toxicities (Escalation and Expansion Cohorts)
Time frame: From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks.
Maximum tolerated dose will be based on number of dose limiting toxicities in each schedule/arm
7 secondary outcomes
Dose Limiting Toxicities on the Selected Arm in the Expansion Cohort
Time frame: From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks.
Objective Response Rate
Time frame: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment (about 8.5 months after starting study treatment). Imaging will then be performed according to standard of care.
Overall Survival
Time frame: Every 3 months following last study visit until death
Progression-Free Survival
Time frame: Checked from enrollment through first progression, about every 3 months, through death or end of study
Immune Response to Treatment in Blood
Time frame: Blood will be collected about 5 weeks before any treatment, just before first HER2 BATs infusion, before HER2 BATs #5, before HER2 BATs #8, and 2 weeks, 1 month, 3 months, and 6 months after last Pembrolizumab
Disease Control Rate
Time frame: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment. Imaging will then be performed according to standard of care.
Duration of Response
Time frame: Imaging will be done prior to study treatment, 1 month, 3 months and 6 months after completion of study treatment. Imaging will then be performed according to standard of care.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25688159Lum LG, Thakur A, Al-Kadhimi Z, Colvin GA, Cummings FJ, Legare RD, Dizon DS, Kouttab N, Maizel A, Colaiace W, Liu Q, Rathore R. Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial. Clin Cancer Res. 2015 May 15;21(10):2305-14. doi: 10.1158/1078-0432.CCR-14-2280. Epub 2015 Feb 16.
- Background: PubMed 25802762Vaishampayan U, Thakur A, Rathore R, Kouttab N, Lum LG. Phase I Study of Anti-CD3 x Anti-Her2 Bispecific Antibody in Metastatic Castrate Resistant Prostate Cancer Patients. Prostate Cancer. 2015;2015:285193. doi: 10.1155/2015/285193. Epub 2015 Feb 23.
- Individual participant dataSharing planned: No
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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.
Patrick Dillon, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HER2 BATs with Pembrolizumab in people with Metastatic Breast Cancer, run by University of Virginia at 1 site 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 16 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose Limiting Toxicities (Escalation and Expansion Cohorts) (time frame: From start of study treatment until 3 weeks after last dose of study treatment, assessed over about 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03272334, which also lists 2 linked publications.
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 27 Feb 2026.