IIT Study of M1-c6v1 Combined With SHR-1210 and Apatinib in Patients With HCC

Sponsor
Liang Peng
Study ID
NCT04665362
Phase
PHASE1
Status
Unknown

Conditions

  • Advanced/Metastatic Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Recombinant oncolytic virus M1, anti PD-1 antibody, Apatinib — DRUG
    Drug: Recombinant oncolytic virus M1 Recombinant oncolytic virus M1 is administered intravenously 1×109 CCIC50 once daily on day1-5, every 28 day cyle. Other name：M1-c6v1 Drug：Anti-PD-1 antibody Anti-PD-1 antibody is administered intravenously 200 mg once every 2 weeks. Other names：SHR-1210, Camrelizumab Drug: Apatinib Apatinib is administered orally 250mg once daily. Other name: Apatinib

Study Details

This is a single arm and open-label phase I trial to evaluate the safety, tolerability and efficacy of the oncolytic virus M1 （M1-c6v1）(iv 1×109 CCIC50, 1 dose per day, on day 1-5 each 28 day cycle) combined with anti-PD-1 antibody SHR-1201 (iv, 200 mg, once every two weeks) and Apatinib (po. 250 mg qd ) in the patients with advanced/metastatic hepatocellular carcinoma. 10 participants will be sequentially enrolled. The treatment duration is 12 months. All patients continue combination treatment until disease progression, unacceptable toxicity, death, or discontinuation for any reason.

Key Dates

Start date
Jan 25, 2021
Status verified
Jan 2021
Primary completion
Jun 1, 2022
Completion
Oct 30, 2022

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: M1-c6v1 combined with SHR-1210 and Apatinib
    Single-arm

Primary Outcome Measure

Treatment related adverse events [ Time Frame: From the first assignment of informed consent form up to 90 days after the last dose ]

Central Contacts