Phase 1 Study of SF1126 in Combination With Nivolumab in Patients With Advanced Hepatocellular Carcinoma

Part of paid clinical trials in La Jolla, California.

Sponsor
SignalRX Pharmaceuticals, Inc.
Study ID
NCT03059147
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SF1126 — DRUG
    SF1126 is a dual PI3 kinase/BRD4 inhibitor small molecule. It will be administered IV twice weekly (900 mg/m2 starting dose with escalation to 1000 mg/m2 per dose and 1100 mg/m2 per dose) at a dose determined by the cohort the patient is enrolled in until progression or unacceptable toxicity develops.
  • Nivolumab — DRUG
    Nivolumab is a humanized, IgG4 isotype monoclonal antibody that binds to PD-1 and blocks binding of PD-1 to its ligands PD-L1 and PD-L2. It will be administered at 240 mg IV every 2 weeks until progression or unacceptable toxicity develops.

Study Details

Primary Objectives: 1. To determine the maximum tolerated dose (MTD) or maximum recommended dose of SF1126 in combination with nivolumab in adult patients with advanced (unresectable or metastatic) HCC and Child-Pugh A or Child-Pugh B7 cirrhosis. 2. To determine the recommended phase II dose of SF1126 in combination with nivolumab in patients with advanced (unresectable or metastatic) HCC and Child-Pugh A or Child-Pugh B7 cirrhosis. Secondary Objectives: 1. To describe the safety and tolerability of SF1126 in adult patients with underlying liver disease by ongoing evaluation of adverse events. 2. To determine pharmacokinetics in HCC patients. 3. To assess the effect of SF1126 in combination with nivolumab on progression-free survival and overall survival. Primary Endpoint: The primary endpoint is the rate of dose limiting toxicities (DLTs) at within 56 days of starting treatment, and the maximum tolerated dose or maximum recommended dose of SF1126 in combination with nivolumab. Secondary Endpoints: 1. Adverse events related to SF1126 (description, timing, grade \[CTCAE v4.03\], severity, seriousness, and relatedness). 2. Pharmacokinetics in HCC patients. 3. The proportion of patients remaining progression-free by radiographic criteria as assessed by RESIST v1.1 at 4 months, and, as available, median progression-free survival and overall survival estimated using the Kaplan-Meier method.

Key Dates

Start date
Mar 27, 2017
Status verified
May 2022
Primary completion
Apr 22, 2019
Completion
Jun 29, 2020

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SF1126 + Nivolumab
    SF1126 900-1100 mg/m2 IV twice weekly + Nivolumab 240 mg IV every 2 weeks

Primary Outcome Measure

Rate of dose limiting toxicities [ Time Frame: Occurring within 56 days of investigational treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-

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By research site
UC San Diego Moores Cancer Center· La Jolla, CA

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