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Unresectable Hepatocellular CarcinomaPhase 1NCT05096715

Atezolizumab+Bevacizumab+SBRT in Unresectable HCC

A Phase 1 study testing Atezolizumab, Bevacizumab and Stereotactic body radiation therapy (SBRT) in people with Unresectable Hepatocellular Carcinoma, run by Massachusetts General Hospital at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This research study is evaluating the safety and tolerability of the drugs atezolizumab and bevacizumab with stereotactic body radiation therapy (SBRT) for treating unresectable hepatocellular carcinoma. This study involves the following interventions: Atezolizumab Bevacizumab Stereotactic body radiation therapy (SBRT) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable Hepatocellular Carcinoma
What is being tested?
Atezolizumab, Bevacizumab and Stereotactic body radiation therapy (SBRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesUnited States
Study dates
23 Aug 2022to 31 Jan 2032
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have diagnosis of hepatocellular carcinoma (HCC) that is deemed unsuitable for surgical resection, transplant, or radiofrequency ablation (RFA). Participants may have up to 5 lesions with a total maximal tumor dimension of < 20 cm, and no one lesion > 15 cm. Diagnosis may be confirmed by at least 1 criteria listed below:
  • Histologically or cytologically proven diagnosis of HCC within 180 days prior to study registration.
  • At least 1 solid liver lesion or vascular tumor thrombus (involving portal vein, IVC, and/or hepatic vein) > 1 cm with arterial enhancement and delayed washout on multiphasic CT or MRI. Radiologic imaging evaluation must occur within 28 days prior to study registration.
  • Enhancing vascular thrombosis demonstrating arterial enhancement and delayed washout of multiphasic MRI. Radiologic imaging evaluation must occur within 30 days prior to study registration.
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
  • Small volume extrahepatic disease permitted, defined as <2.0 cm in sum of maximal diameters (e.g. presence of one 1.8 cm metastatic lymph node, or two 0.8 cm lung lesions are allowed). Bony lesions are included in the <2.0 cm of extrahepatic disease. Note that benign periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm. Radiologic imaging of chest, abdomen, and pelvis via CT or MRI is required within 28 days prior to study registration. CT with contrast is required unless contrast is contraindicated.
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  • Participants may have received transarterial chemoembolization (TACE) or drug eluting beads (DEB). A 2 week (14 day) washout period is required prior to initiating study treatment.
  • Age ≥18 years at the time of signing informed consent document.
  • ECOG performance status 0-1.
  • Child-Pugh A liver function within 7 days of study registration.
  • Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C) within 7 days of study registration.
  • No evidence of significant portal hypertension.
  • Participants must have adequate organ and marrow function as defined the following laboratory results, obtained within 7 days prior to study registration:
  • absolute neutrophil count ≥1,500/mcL
  • absolute lymphocyte count ≥500/mcL
  • platelets ≥75,000/mcL without transfusion
  • hemoglobin ≥9 g/dL, transfusion allowed to meet this criterion
  • total bilirubin ≤ 3 × institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) ≤5 × institutional ULN
  • alkaline phosphatase(ALP) <2 × institutional ULN
  • creatinine ≤ 1.5 × institutional ULN OR
  • estimated creatinine clearance ≥50 mL/min/1.73 m2 (according to the Cockcroft-Gault formula)
  • serum albumin ≥2.8 g/dL
  • INR or aPTT ≤2 × institutional ULN for participants not receiving therapeutic anticoagulation
  • Urine dipstick for proteinuria <2+; participants discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate <1g of protein in 24 hours.
  • Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade ≤ 1 prior to study entry, with the exception of alopecia.
  • No known HIV infection.
  • Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test within 28 days prior to study registration.
  • For participants with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • For participants with active HBV, HBV DNA <500 IU/mL obtained within 28 days prior to initiation of study treatment, and Anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study.
  • Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test within 28 days prior to study registration.
  • Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of contraception to avoid pregnancy during the treatment period and for at least 5 months after the last dose of Atezolizumab or 6 months after the last dose of Bevacizumab. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 14 days prior to study registration.
  • Women must not be breastfeeding.
  • Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year during the treatment period and for 6 months after the last dose of Bevacizumab. Men must refrain from donating sperm during this same period.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Prior systemic therapy
  • Prior radiation to the region of the liver that would result in excessive doses to normal tissues due to overlap of RT fields is not allowed. Radiotherapy within 28 days and abdominal/pelvic radiotherapy within 60 days prior to initiation of study treatment are not allowed. Exception for palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment.
  • Prior selective internal radiotherapy (SIRT) or hepatic arterial Yttrium therapy, at any time.
  • Direct tumor extension into the stomach, duodenum, small bowel, or large bowel.
  • Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 2 cm, in sum of maximal diameters (e.g. presence of one 2.4 cm metastatic lymph node or two 1.2 cm lung lesions).
  • Known fibrolamellar HCC, sarcomatoid HCC, or biphenotypic HCC.
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  • History of leptomingeal disease.
  • GI bleed within 6 months prior to study registration.
  • Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses (<30 mm from the carina) of large volume. Participants with vascular invasion of the portal or hepatic veins may be enrolled.
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
  • Rash must cover < 10% of body surface area
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Active tuberculosis.
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
  • Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to initiation of study treatment.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment is not allowed. Abdominal surgery, abdominal interventions, or significant abdominal traumatic injury within 60 days prior to initiation of study treatment is not allowed. Participants who have not recovered from side effects of any such procedure are ineligible. Anticipation of need for a major surgical procedure during the study should reconsider enrollment.
  • History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g. <% risk of recurrence or 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, superficial bladder cancer, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g. to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
  • Prior allogenic stem call or solid organ transplantation.
  • Clinically significant bleeding or clotting risk requiring treatment.
  • History of hemoptysis (≥2.5 mL of bright red blood per episode) within 1 month prior to initiation of study treatment.
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
  • Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose. Prophylactic anticoagulation for the patency of venous access is allowed provided the activity of the agents results in INR <1.5 x ULN and aPTT is within normal limits within 14 days prior to study registration. Prophylactic use of low molecular-weight heparin (i.e. enoxaparin 40 mg/day) is allowed.
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 3 days prior to the first dose of Bevacizumab.
  • History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment.
  • History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement of routine parenteral hydration, parenteral nutrition, or tube feeding within 6 months prior to initiation of study treatment. Participants with signs/symptoms of sub-/occlusive syndrome/intestinal obstruction at the time of initial diagnosis may be enrolled if they had received definitive (surgical) treatment for the symptom resolution.
  • History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to peptic ulcer disease, diverticulitis, or colitis.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during Atezolizumab treatment or within 5 months after the last dose of Atezolizumab. 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.
  • History of severe anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the Atezolizumab or Bevacizumab formulation.
  • Patients with untreated or incompletely treated varices with bleeding or high risk for bleeding. Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and treated per local standard of care prior to study registration. Patients who have undergone an EGD within 6 months prior to initiation of study treatment do not need to repeat the procedure.
  • Moderate or severe ascites.
  • Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure.
  • Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture.
  • History of hepatic encephalopathy.
  • Active co-infection of HBV and HCV. Participants with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV.
  • Known history of HIV infection.
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Asymptomatic patients with CNS metastases newly detected at screening are eligible for the study after receiving radiotherapy or surgery, with no need to repeat the screening brain scan. Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:
  • Measurable disease, per RECIST v1.1, must be present outside the CNS.
  • Participant has no history of intracranial hemorrhage or spinal cord hemorrhage.
  • Metastases are limited to the cerebellum or the supratentorial region (i.e. no metastases to the midbrain, pons, medulla, or spinal cord).
  • No evidence of interim progression between completion of CNS-directed therapy and initiation of study treatment.
  • Participant has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, neurosurgical resection within 28 days prior to initiation of study treatment.
  • Current or recent (within 10 days of first dose of study treatment) use of aspirin (>325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.
  • Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID) with the exception of daily Aspirin 81 mg. Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed.
  • Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry.
  • Symptomatic lesions (e.g. bone metastases or metastases causing nerve impingement amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.)
  • Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g. epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Participants with indwelling catheters (e.g. PleurX®) are allowed.
  • Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, calcium >12 mg/dL, or corrected serum calcium > ULN)
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment.
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the initiation of study treatment.
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
  • Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g. 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
  • Patients who received mineralocorticoids (e.g. fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
  • Inadequately controlled arterial hypertension (defined as systolic blood pressure (BP) ≥150 mmHg and/or diastolic blood pressure >100 mmHg), based on an average of ≥ 3 BP readings on ≥ 2 sessions. Anti-hypertensive therapy to achieve these parameters is allowable.
  • Prior history of hypertensive crisis or hypertensive encephalopathy.

Trial locations and contacts

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

Jennifer Y Wo, MD contact

(617) 726-6050

jwo@mgh.harvard.edu

United States3 sites, 3 recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Jennifer Y Wo, MD, (617) 726-6050, jwo@mgh.harvard.edu

    Jennifer Y Wo, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Matthew Abrams, MD, 617-667-2345, mabrams2@bidmc.harvard.edu

    Matthew Abrams, MD

    Not yet recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Harvey Mamon, MD, PhD, (617) 732-8821, HMAMON@PARTNERS.ORG

    Harvey Mamon, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: Phase IB Study of Atezolizumab and Bevacizumab With SBRT for Unresectable Hepatocellular Carcinoma

This research study is evaluating the safety and tolerability of the drugs atezolizumab and bevacizumab with stereotactic body radiation therapy (SBRT) for treating unresectable hepatocellular carcinoma.

This study involves the following interventions:

  • Atezolizumab
  • Bevacizumab
  • Stereotactic body radiation therapy (SBRT)
Read the detailed description

This is a single-arm phase 1B study designed to evaluate the combination of Atezolizumab and Bevacizumab with stereotactic body radiation therapy (SBRT for treating and limiting the recurrence of unresectable hepatocellular carcinoma.

The U.S. Food and Drug Administration (FDA) has approved atezolizumab and bevacizumab for unresectable hepatocellular carcinoma. The FDA has not approved the combination of radiation therapy, atezolizumab, and bevacizumab.

Atezolizumab is believed to work by increasing the immune system's response to cancer cells. Bevacizumab is believed to work by inhibiting cancer cells from growing by targeting a specific protein in the cancer cells. Radiation therapy is a standard of care treatment for unresectable hepatocellular carcinoma. Radiation therapy has also been shown to increase the effects of drugs like atezolizumab and bevacizumab.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

Participants will be in this research study for as long as the study drugs are safe and beneficial to them. Participants will then be followed for up to 5 years.

It is expected that about 20-32 people will take part in this research study.

Genentech, a biotechnology company, is supporting this research study by providing funding for the study, including the study drugs.

Being tested
Atezolizumab, Bevacizumab, Stereotactic body radiation therapy (SBRT)
Keywords
Unresectable Hepatocellular Carcinoma

What participants receive

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

  • AtezolizumabDrug

    Also called Tecentriq

    Intravenous Infusion

  • BevacizumabDrug

    Also called Mvasi, Zirabrev

    Intravenous Infusion

  • Stereotactic body radiation therapy (SBRT)Radiation

    Also called Radiation Therapy

    External Beam Radiation

Study groups in NCT05096715
Study groupRoleWhat they receive
Stereotactic beam radiation therapy (SBRT) +Atezolizumab + BevacizumabExperimentalStudy will begin with a safety lead of 6 participants to determine the maximum tolerated dose (MTD) of Stereotactic beam radiation therapy (SBRT) with atezolizumab and bevacizumab followed by study expansion to 14 more participants after maximum tolerated dose (MTD) is established. Safety Lead-In: 6 cycles/18 weeks (study cycle is 3 weeks/21 days) * Cycle 1: Atezolizumab + Bevacizumab (1x) with Stereotactic beam radiation therapy (SBRT) every 1-3 days * Cycles 2-6: Atezolizumab + Bevacizumab (1x) every 3 weeks Expanded Study: * Cycle 1: Atezolizumab + Bevacizumab (1x) with Stereotactic beam radiation therapy (SBRT) every 1-3 days * Cycles 2-End:Atezolizumab + Bevacizumab (1x) every cycle
Receives: Drug: Atezolizumab; Drug: Bevacizumab; Radiation: Stereotactic body radiation therapy (SBRT)

What is being measured

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

  1. Dose Limiting Toxicity Rate

    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: 18 weeks

Secondary outcomes (5)

  1. Progression free survival (PFS)

    Assessed per HCC mRECIST, imRECIST, and RECIST v1.1

    Measured: 5 years

  2. Overall Survival (OS)

    Estimated using the Kaplan-Meier method

    Measured: 5 years

  3. In-field response rate

    Assessed per RECIST v1.1, imRECIST, and HCC mRECIST

    Measured: 5 years

  4. Change in Child-Pugh Score

    Analyzed as repeated measures using mixed models to characterize the trend over time. Child-Pugh scores range from 5 to 15, with higher scores indicating worse outcomes.

    Measured: 2.5 years

  5. Out of field response rate

    Assessed per RECIST v1.1, imRECIST and HCC mRECIST among patients with low volume metastatic disease

    Measured: 2.5 years

Timeline

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

  1. First posted27 Oct 2021
  2. Study start23 Aug 2022
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2032 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05096715
Sponsor's protocol ID
21-286
Status last verified
Feb 2026
First submitted
30 Aug 2021
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab, Bevacizumab and Stereotactic body radiation therapy (SBRT) in people with Unresectable Hepatocellular Carcinoma, run by Massachusetts General Hospital at 3 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 36 inclusion and 65 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: looking for participants now, as of the sponsor's last update on 18 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 3 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?

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?

Contact Jennifer Y Wo, MD ((617) 726-6050, jwo@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity Rate (time frame: 18 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 NCT05096715.

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 18 Feb 2026.

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