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New treatment option for Hepatocellular Carcinoma
Official title Cryoablation and Arterial Infusion of SD-101 in Combination With Durvalumab and Tremelimumab
ClinicalTrials.gov ID: NCT06710223
What this study is testing
What is SD-101?
SD-101 is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as nelitolimod.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this Phase 1b clinical trial is to evaluate the safety and efficacy of cryoablation and hepatic arterial administration of SD-101 in participants with advanced hepatocellular carcinoma. After this procedure, participants will be treated with tremelimumab and durvalumab every 4 weeks (STRIDE regimen).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing and able to provide written informed consent prior to performance of any study- specific procedures.
- Age ≥ 18 years.
- Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by...
- For cirrhotic participants with no histological confirmation of diagnosis, clinical confirmation is required per AASLD criteria.
- Pathological diagnoses of HCC will be made according to the International Working Party criteria.
You likely can't join if
- Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before study entry, and stable without steroid treatment...
- Evidence of severe or uncontrolled systemic diseases [e.g., unstable or uncompensated respiratory, cardiac (including life threatening arrhythmias)].
- Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered...
- Presence of cardiac impairment defined as:
- prior history of cardiovascular disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions; OR
- history of myocardial infarction/active ischemic heart disease within one year of study entry; OR
See the full eligibility criteria
- Willing and able to provide written informed consent prior to performance of any study- specific procedures.
- Age ≥ 18 years.
- Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in...
- For cirrhotic participants with no histological confirmation of diagnosis, clinical confirmation is required per AASLD criteria.
- Pathological diagnoses of HCC will be made according to the International Working Party criteria.
- HCC with a component that measures at least 3 cm and that is located 1 cm or greater away from sensitive structures, including large blood vessels, large bile ducts, pericardium, diaphragm, gallbladder, stomach, and...
- Is not a candidate for local therapies alone, including liver transplantation, tumor ablation, transarterial embolization, radiation therapy, or resection.
- No prior systemic therapy for advanced or metastatic HCC.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Evaluable target lesions as per Response Evaluation Criteria in Solid Tumors RECIST v1.1 or mRECIST.
- Child-Pugh A or Child-Pugh B7 liver function.
- Life expectancy of ≥ 12 weeks.
- Adequate bone marrow function defined as:
- Peripheral absolute neutrophil count ≥ 1000/mm\^3
- Platelet count ≥ 50,000/ mm\^3
- Hemoglobin ≥ 8.0 g/dL
- Adequate renal function defined as creatinine clearance ≥ 50 ml/min
- Adequate liver and pancreatic function defined as:
- Total bilirubin ≤ 2.0 x institution's upper limit of normal, and
- Alanine transaminase (ALT) or Aspartate transaminase (AST) ≤ 5 x institution's upper limit of normal, and
- Albumin ≥ 2 g/dL
- Adequate central nervous system function defined as: a. patients with seizure disorder may be enrolled if on anticonvulsants and seizures are well controlled.
- Systolic blood pressure \<160 mm Hg.
- Patients with partners of childbearing potential must agree to use adequate contraception during participation in the study.
- Patients able to become pregnant are eligible to enter the study if they are either:
- Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including: i. Has had a hysterectomy; or ii. Has had a bilateral oophorectomy, or iii. Has had a bilateral tubal ligation, or iv. Is...
- Of childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following contraceptives: i. An intrauterine device with a documented failure rate of less than 1% per year; ii...
- Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before study entry, and stable without steroid treatment for at least 4 weeks.
- Evidence of severe or uncontrolled systemic diseases [e.g., unstable or uncompensated respiratory, cardiac (including life threatening arrhythmias)].
- Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
- Presence of cardiac impairment defined as:
- prior history of cardiovascular disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions; OR
- history of myocardial infarction/active ischemic heart disease within one year of study entry; OR
- uncontrolled dysrhythmias; OR
- poorly controlled angina
- Participation in a trial of an investigational agent within the prior 30 days
- Pregnant or breast-feeding.
- High volume peritoneal or pleural effusions requiring centesis more frequently than every 14 days.
- Poorly controlled or refractory (grade 3-4) hepatic encephalopathy.
- History of allogeneic stem cell or solid organ transplantation.
- Prior history of pneumonitis/interstitial lung disease.
- Receipt of live vaccine within 30 days.
- Active or prior documented autoimmune or inflammatory disorders (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel...
- Vitiligo or alopecia.
- Autoimmune-related hypothyroidism stable on thyroid replacement therapy.
- Any chronic skin condition that does not require systemic therapy.
- Controlled type 1 diabetes mellitus who are on an insulin regimen.
- Celiac disease controlled by diet alone.
- Without active disease in the last 5 year.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra-articular injection).
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
- Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
- Any concurrent condition that, in the investigator's opinion, makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.