Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors (NCT05220722) | Clinical Trial Compass
TerminatedPhase 1/2
Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors
Stopped: The decision was made to terminate the study after the completion of Phase 1b enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.
United States23 participantsStarted 2022-03-02
Plain-language summary
This is an Open-label, Phase 1b/2 Study of the Pressure-Enabled Hepatic Artery Infusion (HAI) of SD-101, a TLR9 agonist, Alone or in Combination with Intravenous Checkpoint Blockade in Adults with Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC).
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years of age or older with locally advanced, metastatic or unresectable hepatocellular carcinoma or intrahepatic cholangiocarcinoma, with the diagnosis confirmed by radiologic, histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases.
. Previously received 1 line of standard therapy for liver cancer and with persistent or progressive measurable disease, as defined by RECIST version 1.1, that is not amenable to curative therapies
. Performance status score of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale (scores range from 0 to 5, with higher numbers reflecting greater disability)
. Designation of class A to B7 on the Child-Pugh liver function scale (a three-category scale \[A, B, or C\], with C indicating the most severe compromise of liver function)
. Adequate hematologic and organ function.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1b: To Determine the Safety of SD-101 Alone, in Combination with Pembrolizumab, and in Combination with Nivolumab and Ipilimumab
Timeframe: 12 months
2
Phase 1b: To Determine the Maximum Tolerable Dose (MTD) or Optimal Dose of SD-101 alone, in Combination with Pembrolizumab, and in Combination with Nivolumab and Ipilimumab
. Has radiographically, histologically or cytologically confirmed HCC or ICC with liver-only or liver-dominant disease. Liver-dominant will be defined as intrahepatic disease representing the largest fraction of disease.
. Able to understand the study and provide written informed consent prior to any study procedures
. Has not received prior cytotoxic chemotherapy, targeted therapy, or external radiation therapy within 14 days prior to C1D1
Exclusion criteria
0. Has no prior history of or other concurrent malignancy unless the malignancy is clinically insignificant, no ongoing treatment is required, and the patient is clinically stable
1. Has measurable disease in the liver according to RECIST v.1.1 criteria
2. Has a life expectancy of \>3 months at screening as estimated by the investigator
3. Has a QTc interval ≤480 msec
4. All associated clinically significant (in the judgment of the investigator) drug-related toxicity from previous cancer therapy must be resolved (to Grade ≤1 or the patient's pretreatment level) prior to study treatment administration (Grade 2 alopecia and endocrinopathies controlled on replacement therapy are allowed).
5. Has adequate organ function at screening as evidenced by:
6. Females of childbearing potential must be nonpregnant and nonlactating, or post-menopausal, and have a negative serum human chorionic gonadotropin (hCG) pregnancy test result at screening and a negative urine or serum pregnancy test prior to the first dose of study intervention.
7. For patients with a documented FGFR2 mutation, prior treatment with a FGFR2-targeted agent or refusal of treatment with at least one of these agents must be documented. For patients with a documented IHD1 mutation, prior treatment with an IHD1 targeted agent or refusal of treatment with ivosidenib must be documented.