Not Yet RecruitingPhase 1/2

Clinical Study of VG161 Combined With Camrelizumab in Patients With Advanced Primary Hepatocellular Carcinoma

36 participantsStarted 2023-11-30

Plain-language summary

VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection.This study will be conducted in combination with camrelizumab in patients with advanced advanced primary hepatocellular carcinoma who have received at least one first-line treatment regimen. This is an open-label study divided into two parts. Part 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination. Part 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.

Who can participate

Age range18 Years – 75 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

✓. Routine blood (no blood transfusion or colony-stimulating factor therapy within 14 days): ANC≥ 1.5×109/L, PLT≥75×109/L, Hb≥85g/L, lymphocyte count ≥1.5×109/L (for lymphocyte count 0.8×109/L to 1.5×109/L is determined by the investigator whether to enroll);
✓. Liver function: TBIL≤1.5×ULN, ALT≤5×ULN, AST≤5×ULN;
✓. Child-Pugh A or better B (≤ 7);
✓. Renal function: Cr≤1.5×ULN, and creatinine clearance ≥ 45ml/min (calculated according to Cockcroft-Gault formula);
✓. Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR) ≤1.5×ULN.

Exclusion criteria

✕. Ventricular arrhythmias requiring clinical intervention;
✕. QTc interval\>480ms;
✕. Acute coronary syndrome, congestive heart failure, stroke or other grade III or above cardiovascular events within 6 months;
✕. New York Heart Association (NYHA) cardiac function class ≥ class II or left ventricular ejection fraction (LVEF) \<40%;
✕. Uncontrolled hypertension (systolic blood pressure ≥140mmHg, or diastolic blood pressure ≥90mmHg after treatment).

What they're measuring

Phase Ib:RP2D/MTD

Timeframe: through Phase Ib study completion, an average of 8 months

Phase Ib:Incidence and number of DLT

Timeframe: through Phase Ib study completion, an average of 8 months

Phase Ib:AE, SAE occurrence and frequency

Timeframe: through Phase Ib study completion, an average of 8 months

Phase IIa:ORR

Timeframe: Time Frame: through Phase IIa study completion, an average of 1 year

Trial details

NCT IDNCT06124001

SponsorCNBG-Virogin Biotech (Shanghai) Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30

Contact for this trial

Tingbo Liang, MD.PhD.

0571-87236666 liangtingbo@zju.edu.cn

View on ClinicalTrials.gov More Primary Hepatocellular Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years – 75 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

✓. Routine blood (no blood transfusion or colony-stimulating factor therapy within 14 days): ANC≥ 1.5×109/L, PLT≥75×109/L, Hb≥85g/L, lymphocyte count ≥1.5×109/L (for lymphocyte count 0.8×109/L to 1.5×109/L is determined by the investigator whether to enroll);
✓. Liver function: TBIL≤1.5×ULN, ALT≤5×ULN, AST≤5×ULN;
✓. Child-Pugh A or better B (≤ 7);
✓. Renal function: Cr≤1.5×ULN, and creatinine clearance ≥ 45ml/min (calculated according to Cockcroft-Gault formula);
✓. Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR) ≤1.5×ULN.

Exclusion criteria

✕. Ventricular arrhythmias requiring clinical intervention;
✕. QTc interval\>480ms;
✕. Acute coronary syndrome, congestive heart failure, stroke or other grade III or above cardiovascular events within 6 months;
✕. New York Heart Association (NYHA) cardiac function class ≥ class II or left ventricular ejection fraction (LVEF) \<40%;
✕. Uncontrolled hypertension (systolic blood pressure ≥140mmHg, or diastolic blood pressure ≥90mmHg after treatment).

What they're measuring

Phase Ib:RP2D/MTD

Timeframe: through Phase Ib study completion, an average of 8 months

Phase Ib:Incidence and number of DLT

Timeframe: through Phase Ib study completion, an average of 8 months

Phase Ib:AE, SAE occurrence and frequency

Timeframe: through Phase Ib study completion, an average of 8 months

Phase IIa:ORR

Timeframe: Time Frame: through Phase IIa study completion, an average of 1 year