Glioblastoma (GBM)Phase 1/2NCT07762716

Combination Immunotherapy Treatment for Glioblastoma Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy

A Phase 1/2 study testing BreakVax, Ipilimumab 2.5 mg and Pembrolizumab in people with Glioblastoma (GBM), run by BreakBio Corp at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 72 years
Conditions the study is for: Glioblastoma (GBM)
What is being tested?: BreakVax, Ipilimumab 2.5 mg and Pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Sep 2026to Sep 2030
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

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 72 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years and < 72
Patients with histologically confirmed GBM who have sent 200 mg (approximately) of tumor tissue (fresh tissue immersed in AllProtect then frozen) to BreakBio for analysis.
KPS of 80 or greater on day of first dose
Patient has adequate organ function on day one of the trial as defined by:
Neutrophil to Lymphocyte Ratio (NLR)1 at a healthy adult's normal level: ≤ 3.5
Absolute Neutrophil Count (ANC) at the normal level: ≤ 7,000/mm3

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Absolute Lymphocyte Count in normal level: ≥ 1,000/mm3
Monocytes at normal level: < 700/mm3
Platelet count: ≥ 100 x 109/L (without transfusion support in the last two weeks)
Hemoglobin: > 10.0 g/dL (without transfusion support in the last two weeks)
AST and ALT: ≤ 3 X institutional upper limit of normal (ULN) in the absence of liver mets; AST and/or ALT may be ≤ 5 x ULN in the setting of liver metastases
Total Bilirubin at the normal level: ≤ 1.2mg/dL
Serum creatinine: ≤ 1.5 x institution's ULN
Albumin at the normal level: ≥ 3.4 g/dL
Serum Magnesium at normal level: ≥ 1.7 mg/dL
Pulse oximetry ≥ 92% on room air.
Provision of consent for on-treatment biopsy (compulsory) and post-treatment biopsy (optional).
Both male and female patients enrolled in this trial must agree to use effective contraception during the course of the trial and for at least 3 months after discontinuing study treatment. Patients and/or partners who are surgically sterile or postmenopausal are exempt from this requirement.
Negative pregnancy test ≤ 7 days prior to day one of cycle 1, for women of childbearing potential only.
Life expectancy > 6 months.
Willing and able to provide informed consent

Who cannot join

Prior exposure to anti PD- 1/PD-L1 agents.
Prior exposure to immunosuppressive therapy within the last 12 months prior to enrollment.
Receiving or previously receiving oral or IV steroids within 6 weeks of starting study treatment. Currently using or previously used topical steroids within 6 weeks of starting study treatment. Expected to require steroid-containing pre-meds before chemotherapy doses.
Patients with deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) phenotype
Any liver metastasis greater than 2 cm or greater than 5 liver metastases. Patients who have liver metastasis removed by surgery, and therefore meet this criterion at first dose, may enroll.
Patients not recovered from all clinically significant toxic effects of previous therapies to ≤Grade 1 or baseline with the exception of peripheral neuropathy and alopecia.

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Patients not recovered adequately from the toxicity and/or complications from any major surgery prior to starting study treatment.
Known or suspected hypersensitivity to any of the study drugs.
Received an investigational agent within 28 days prior to the first dose of study drug.
History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction within the past 6 months. Note: Prior to trial entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
LVEF <50%.
Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids.
Known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. Individuals who are hepatitis C antibody positive may be enrolled if negative viral load confirmed.
History of autoimmune disease including inflammatory bowel disease (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g. Wegener's granulomatosis); central nervous system or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barré syndrome, myasthenia gravis, multiple sclerosis). Individuals with vitiligo, Sjogren's Syndrome, interstitial cystitis, Graves' or Hashimoto's Disease, celiac disease, DM1, hypothyroidism stable on hormone replacement, or any autoimmune disease without symptoms and not requiring active therapy for at least 2 years will be allowed with Study Medical Monitor's approval.
A serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) which requires systemic antibiotic treatment within 4 weeks prior to the first dose of study medication.
Receiving coumarin-derived anticoagulants.
Unable or unwilling to withhold or discontinue any prohibited or restricted medications/procedures for the specified windows during the study.
Inability or refusal to comply with the protocol or with the clinical trial procedures.
If female, pregnant or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to starting treatment.
Chronic intake of drugs that lead to known interference with metabolism through strong Cytochrome P450 3A4 (CYP3A4) interaction: e.g. Rifampicin, Rifabutin, Clarithromycin, Telithromycin, Ketoconazole, Itraconazole, Fluconazole, Hypericum perforatum (St. John's Wort /Johanniskraut) or any strong CYP3A4 inducing or inhibiting drug (Note: participants in this study should avoid consuming grapefruit or grapefruit-containing products during the duration of the study, including the screening phase, treatment period, and follow-up period).
Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy.
Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months before the start of study medication. Active pulmonary emboli or deep vein thrombosis that are significant or not adequately controlled on anticoagulation regimen
Any hemorrhage or bleeding event ≥ National Cancer Institute - Common terminology criteria for adverse events (NCI-CTCAE) Grade 3 within 28 days prior to the start of study medication
History of other invasive cancer within 2 years prior to enrollment, except for treated non-melanoma skin cancer
Known DNA Polymerase Epsilon (POLE) mutations

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Miami Herbert Wertheim Cancer Institute
Miami, Florida, 33176
Manmeet Ahluwalia, MD, MBA, FASCO

Other trials in United States

About this study

Official title: Phase 1/2 Trial of a Combination Immunotherapy Treatment for Solid Tumors Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy

The objective of this study is to evaluate the safety, feasibility, and preliminary antitumor activity of this multi-component immunotherapy strategy in patients with advanced solid tumors. The study is designed to assess whether coordinated enhancement of antigen-specific T-cell priming and tumor microenvironment modulation can improve immune-mediated tumor control.

In this study, BreakVax with adjuvants (Montanide and Poly-ICLC) is administered in combination with:

Low-dose subcutaneous ipilimumab at the injection site as a dendritic cell adjuvant to enhance local dendritic cell-mediated T-cell priming;
Pembrolizumab to mitigate PD-1-mediated T-cell exhaustion and sustain effector function;
Standard-of-care chemotherapy, which may promote immunogenic cell death, increase antigen release and modulate the tumor microenvironment; and
Losartan and aspirin, which have been associated in preclinical and translational studies with modulation of stromal architecture, vascular normalization, and reduction of tumor-associated immunosuppressive signaling.

This is a Phase 1/2, multi-center, open-label single-arm clinical study in adult patients who have Glioblastoma (GBM).

The study consists of two components: a Safety Lead-in Cohort and a combination therapy cohort. The Safety Lead-in Cohort is designed to evaluate safety and tolerability of the study combination and to characterize dose-limiting toxicities (DLTs). The combination therapy cohort portion intends to evaluate the superiority of the study combination treatment vs the SOC chemotherapy, measured by OS at 12 months

Conditions: Glioblastoma (GBM)
Being tested: BreakVax, Ipilimumab 2.5 mg, Pembrolizumab, Temozolomide (TMZ), Losartan and aspirin
Keywords: Glioblastoma, GBM
Medical subject headings: Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BreakVaxDrug
An investigational, personalized peptide-based cancer immunotherapy designed to stimulate patient-specific antitumor T-cell responses. For each patient, tumor tissue undergoes integrated genomic, transcriptomic, and proteomic analysis to identify tumor-associated antigens (TAAs) and tumor-specific neoantigens (TSAs). A proprietary selection algorithm prioritizes peptides predicted to be presented by the patient's HLA molecules and selectively expressed or overexpressed in tumor tissue. The resulting individualized peptide pools are manufactured, formulated with adjuvants (Montanide ISA 51 and Poly-ICLC), and administered subcutaneously
Ipilimumab 2.5 mgDrug
Low-dose subcutaneous ipilimumab at the injection site as a dendritic cell adjuvant to enhance local dendritic cell-mediated T-cell priming
PembrolizumabDrug
To mitigate PD-1-mediated T-cell exhaustion and sustain effector function
Temozolomide (TMZ)Drug
May promote immunogenic cell death, increase antigen release and modulate the tumor microenvironment
Losartan and aspirinDrug
Have been associated in preclinical and translational studies with modulation of stromal architecture, vascular normalization, and reduction of tumor-associated immunosuppressive signaling

Study groups in NCT07762716
Study group	Role	What they receive
BreakVax Arm	Experimental	A cycle for this study is defined as 28 days. BreakVax along with adjuvants and low-dose subcutaneous ipilimumab (as an adjuvant) will be administered on Day 1 and D15 of Cycle 1, and will then be administered on D1 of every cycle thereafter until disease progression per RANO criteria. In addition to BreakVax, patients in the BreakVax Arm will receive losartan daily and temozolomide - without steroid pre-medications (see disallowed concomitant treatment below). Patients will receive aspirin QD except the day BreakVax is administered and the 2 following days in cycles in which the patient is receiving BreakVax. Patients will begin pembrolizumab on Day 21 of Cycle 2 and it will then be administered every 6 weeks thereafter Receives: Drug: BreakVax; Drug: Ipilimumab 2.5 mg; Drug: Pembrolizumab; Drug: Temozolomide (TMZ); Drug: Losartan and aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival (OS)
Measured: 12 Months
Percentage of patients for whom BreakVax is successfully manufactured
Measured: up to 24 Months
Adverse events
Measured: up to 24 Months

Secondary outcomes (10)

T-cell infiltration
Change in tumor-infiltrating T-cells between the pre-treatment biopsy and the on-treatment biopsy
Measured: From pre-treatment biopsy to on-treatment biopsy (Cycle 2 after imaging)
Immune-related Objective Response Rate (irORR) per iRANO
Percentage of participants with measurable enhancing disease at baseline who achieve an immune-related complete response or partial response according to iRANO criteria, as assessed by a central independent review committee (IRC).
Measured: From start of study treatment through disease progression or end of treatment, up to 2 years.
Progression-Free Survival (PFS) per RANO
Time from the start of study treatment to the first documentation of progressive disease according to RANO criteria or death from any cause, whichever occurs first, as assessed by a central independent review committee (IRC). Participants without documented progression or death will be censored according to the Statistical Analysis Plan.
Measured: From start of study treatment through progression or death, up to 2 years.
Duration of Response (DoR) per RANO
Among participants who achieve a complete response or partial response according to RANO criteria, duration of response is measured from the first date on which criteria for complete response or partial response are met until the first date on which recurrent or progressive disease is objectively documented or death occurs, as assessed by a central independent review committee (IRC).
Measured: From first documented CR or PR through progression or death, up to 2 years.
Clinical Benefit Rate (CBR) per RANO
Percentage of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) lasting at least 12 weeks according to RANO criteria, as assessed by a central independent review committee (IRC).
Measured: From start of study treatment through disease progression or end of treatment, up to 2 years.
Objective Response Rate (ORR) per RANO
Percentage of participants with measurable enhancing disease at baseline who achieve a complete response (CR) or partial response (PR) according to RANO criteria, as assessed by a central independent review committee (IRC).
Measured: From start of study treatment through disease progression or end of treatment, up to 2 years.
Immune-related Progression-Free Survival (irPFS) per iRANO
Time from the start of study treatment to confirmed disease progression according to iRANO criteria or death from any cause, whichever occurs first. Unconfirmed progression does not constitute a progression event until confirmation according to iRANO criteria.
Measured: From start of study treatment through confirmed progression or death, up to 2 years.
Incidence of Pseudoprogression per iRANO
Percentage of participants who experience apparent radiographic progression that is subsequently determined not to represent true disease progression according to iRANO criteria.
Measured: From start of study treatment through disease progression or end of treatment, up to 2 years.
Stable Disease for at Least 12 Weeks per iRANO
Percentage of participants whose best response is stable disease according to iRANO criteria for at least 12 weeks, using the protocol-specified assessment window of 12 weeks ±1 week.
Measured: From start of study treatment through disease progression or end of treatment, up to 2 years.
Overall Survival (OS)
Time from the start of study treatment to death from any cause.
Measured: Up to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2026Sep 2030

First posted13 Aug 2026
Study startSep 2026 (estimated)
Primary completionSep 2030 (estimated)
Study completionSep 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Glioblastoma (GBM)Studies 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07762716
Sponsor's protocol ID: BreakBio-3 Substudy B
Status last verified: Aug 2026
First submitted: 7 Aug 2026
Last updated: 19 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
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Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma

All Glioblastoma (GBM) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/2 Trial of a Combination Immunotherapy Treatment for Solid Tumors Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy
ClinicalTrials.gov ID: NCT07762716
Acronym / sponsor ID: BreakBio-3 Substudy B
Conditions: Glioblastoma (GBM)
Keywords: Glioblastoma, GBM
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 10 participants (estimated)
Lead sponsor: BreakBio CorpIndustry (pharma, biotech, devices)
Collaborators: Miami Cancer Institute
Study start: Sep 2026 (estimated)
Primary completion: Sep 2030 (estimated)
Study completion: Sep 2030 (estimated)
First posted: 13 Aug 2026 (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.

In this study, BreakVax with adjuvants (Montanide and Poly-ICLC) is administered in combination with:

Low-dose subcutaneous ipilimumab at the injection site as a dendritic cell adjuvant to enhance local dendritic cell-mediated T-cell priming;
Pembrolizumab to mitigate PD-1-mediated T-cell exhaustion and sustain effector function;
Standard-of-care chemotherapy, which may promote immunogenic cell death, increase antigen release and modulate the tumor microenvironment; and
Losartan and aspirin, which have been associated in preclinical and translational studies with modulation of stromal architecture, vascular normalization, and reduction of tumor-associated immunosuppressive signaling.

This is a Phase 1/2, multi-center, open-label single-arm clinical study in adult patients who have Glioblastoma (GBM).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BreakVax Arm	Experimental	Drug: BreakVax, Drug: Ipilimumab 2.5 mg, Drug: Pembrolizumab, Drug: Temozolomide (TMZ), Drug: Losartan and aspirinA cycle for this study is defined as 28 days. BreakVax along with adjuvants and low-dose subcutaneous ipilimumab (as an adjuvant) will be administered on Day 1 and D15 of Cycle 1, and will then be administered on D1 of every cycle thereafter until disease progression per RANO criteria. In addition to BreakVax, patients in the BreakVax Arm will receive losartan daily and temozolomide - without steroid pre-medications (see disallowed concomitant treatment below). Patients will receive aspirin QD except the day BreakVax is administered and the 2 following days in cycles in which the patient is receiving BreakVax. Patients will begin pembrolizumab on Day 21 of Cycle 2 and it will then be administered every 6 weeks thereafter

Who may qualify

Ages: 18 to 72 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Age ≥ 18 years and < 72
Patients with histologically confirmed GBM who have sent 200 mg (approximately) of tumor tissue (fresh tissue immersed in AllProtect then frozen) to BreakBio for analysis.
KPS of 80 or greater on day of first dose
Patient has adequate organ function on day one of the trial as defined by:
Provision of consent for on-treatment biopsy (compulsory) and post-treatment biopsy (optional).

Key exclusion criteria (25 listed)

Prior exposure to anti PD- 1/PD-L1 agents.
Prior exposure to immunosuppressive therapy within the last 12 months prior to enrollment.
Receiving or previously receiving oral or IV steroids within 6 weeks of starting study treatment. Currently using or previously used topical steroids within 6 weeks of starting study treatment. Expected to require steroid-containing pre-meds before chemotherapy doses.
Patients with deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) phenotype
Any liver metastasis greater than 2 cm or greater than 5 liver metastases. Patients who have liver metastasis removed by surgery, and therefore meet this criterion at first dose, may enroll.

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
BreakVaxAn investigational, personalized peptide-based cancer immunotherapy designed to stimulate patient-specific antitumor T-cell responses. For each patient, tumor tissue undergoes integrated genomic, transcriptomic, and proteomic analysis to identify tumor-associated antigens (TAAs) and tumor-specific neoantigens (TSAs). A proprietary selection algorithm prioritizes peptides predicted to be presented by the patient's HLA molecules and selectively expressed or overexpressed in tumor tissue. The resulting individualized peptide pools are manufactured, formulated with adjuvants (Montanide ISA 51 and Poly-ICLC), and administered subcutaneously	Drug	BreakVax Arm
Ipilimumab 2.5 mgLow-dose subcutaneous ipilimumab at the injection site as a dendritic cell adjuvant to enhance local dendritic cell-mediated T-cell priming	Drug	BreakVax Arm
PembrolizumabTo mitigate PD-1-mediated T-cell exhaustion and sustain effector function	Drug	BreakVax Arm
Temozolomide (TMZ)May promote immunogenic cell death, increase antigen release and modulate the tumor microenvironment	Drug	BreakVax Arm
Losartan and aspirinHave been associated in preclinical and translational studies with modulation of stromal architecture, vascular normalization, and reduction of tumor-associated immunosuppressive signaling	Drug	BreakVax Arm

Primary outcome

Overall Survival (OS)
Time frame: 12 Months
Percentage of patients for whom BreakVax is successfully manufactured
Time frame: up to 24 Months
Adverse events
Time frame: up to 24 Months

10 secondary outcomes

T-cell infiltration
Time frame: From pre-treatment biopsy to on-treatment biopsy (Cycle 2 after imaging)
Immune-related Objective Response Rate (irORR) per iRANO
Time frame: From start of study treatment through disease progression or end of treatment, up to 2 years.
Progression-Free Survival (PFS) per RANO
Time frame: From start of study treatment through progression or death, up to 2 years.
Duration of Response (DoR) per RANO
Time frame: From first documented CR or PR through progression or death, up to 2 years.
Clinical Benefit Rate (CBR) per RANO
Time frame: From start of study treatment through disease progression or end of treatment, up to 2 years.
Objective Response Rate (ORR) per RANO
Time frame: From start of study treatment through disease progression or end of treatment, up to 2 years.
Immune-related Progression-Free Survival (irPFS) per iRANO
Time frame: From start of study treatment through confirmed progression or death, up to 2 years.
Incidence of Pseudoprogression per iRANO
Time frame: From start of study treatment through disease progression or end of treatment, up to 2 years.
Stable Disease for at Least 12 Weeks per iRANO
Time frame: From start of study treatment through disease progression or end of treatment, up to 2 years.
Overall Survival (OS)
Time frame: Up to 5 years.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Individual participant dataSharing planned: Undecided

Related trials for Glioblastoma (GBM)

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
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RecruitingPhase 1/2
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 BreakVax, Ipilimumab 2.5 mg and Pembrolizumab in people with Glioblastoma (GBM), run by BreakBio Corp 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 21 inclusion and 25 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: opening soon, as of the sponsor's last update on 19 Aug 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?

This study is still under way. Results are not available in the source record yet.

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?

Overall Survival (OS) (time frame: 12 Months). The study lists 3 primary outcomes in all. 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 NCT07762716.

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 19 Aug 2026.