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 range18 Years – 99 Years
SexALL
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.
✓. 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
✓
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 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.