Evaluate the Safety and Efficacy of Combination Therapy With SYS6090 Injection for Hepatocellular Carcinoma

NCT07761286 | Not Yet Recruiting Phase 1

• 1 other identifier: SYS6090-007
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of combination therapy with SYS6090 Injection in participants with hepatocellular carcinoma (HCC).

Conditions

HCC - Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Evaluated incidence and severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per NCI-CTCAE version 6.0, including abnormal laboratory tests, ECG parameters and vital signs from screening through end of safety follow-up.

  Up to 2 years.

• Overall response rate (ORR)

  ORR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the percentage of participants with at least one visit confirmed complete response (CR) or partial response (PR).

  Up to 2 years.

• DLT；RP2D and MTD

  The Phase Ib study will explore the DLTs and MTD of SYS6090 combination therapy, and the RP2D will be determined based on the results from the Phase Ib study.

  Up to 2 years.

Study Arms (3)

SYS6090+ BEV

EXPERIMENTAL

Drug: SYS6090 Injection + Bevacizumab Injection

SYS6090+SYS6043+ BEV

EXPERIMENTAL

Drug: SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection

BEV + SIN

EXPERIMENTAL

Drug: Bevacizumab Injection + Sintilimab Injection

Interventions

SYS6090 Injection + Bevacizumab Injection DRUG

SYS6090 in Combination with Bevacizumab 15mg/kg

SYS6090+ BEV

SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection DRUG

SYS6090 in Combination with SYS6043 and Bevacizumab 15mg/kg

SYS6090+SYS6043+ BEV

Bevacizumab Injection + Sintilimab Injection DRUG

Bevacizumab 15mg/kg in Combination with Sintilimab 200mg, intravenous infusion, every 3 weeks.

BEV + SIN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant voluntarily signs the informed consent form.
• Aged ≥18 years at the time of informed consent acquisition.
• Confirmed diagnosis of hepatocellular carcinoma (HCC) via histopathology, cytopathology, or clinical diagnosis in accordance with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2026 Edition).
• Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B unsuitable for curative surgery and/or locoregional therapy.
• Child-Pugh score \<7 and no history of hepatic encephalopathy.
• No prior systemic anti-tumor therapy for HCC. Prior systemic therapy administered in the neoadjuvant or adjuvant setting is permitted, provided that the time from the last dose of prior therapy to tumor recurrence is ≥6 months.
• At least one measurable lesion per RECIST Version 1.1. Lesions previously treated with interventional therapy, radiotherapy or ablation may be counted as measurable lesions if clear disease progression is documented per RECIST v1.1 and the lesion meets measurable lesion criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• Expected survival ≥3 months.
• Adequate organ function as defined below:
• Hematology: PLT ≥100×10⁹/L; Hb ≥90 g/L; ANC ≥1.5×10⁹/L (no blood transfusion, platelet transfusion or hematopoietic stimulating factor administered within 14 days prior to hematology testing at screening);
• Liver function: AST and ALT ≤5×ULN; TBIL ≤1.5×ULN;
• Renal function: Ccr \>50 mL/min (calculated by the Cockcroft-Gault formula); urine protein \<2+; participants with urine protein ≥2+ must have a 24-hour urine protein quantification \<1 g;
• Coagulation function: APTT ≤1.5×ULN; INR ≤1.5×ULN. Participants receiving full-dose oral anticoagulants must maintain a stable dose for a minimum of 14 days;
• Albumin: ≥30 g/L (equivalent to ≥3.0 g/dL).

You may not qualify if:

• Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma.
• Received any anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or any investigational trial intervention within 4 weeks prior to the first study drug administration or within 5 half-lives of the most recent anti-tumor agent (whichever is shorter); or received Chinese patent medicines with anti-tumor indications, palliative radiotherapy, or locoregional therapy within 14 days prior to the first study drug administration.
• Underwent major visceral surgery (excluding core needle biopsy) or sustained severe trauma within 4 weeks prior to the first study drug administration, or planned elective surgery during the study period.
• Received systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first study drug administration, except for the following scenarios: physiologic replacement doses of hydrocortisone or equivalent hormones (i.e., prednisone ≤10 mg/day or equivalent); topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-course corticosteroids for prophylaxis (e.g., prophylaxis against contrast medium allergy).
• Received live vaccines within 4 weeks prior to the first study drug administration. Note: Seasonal influenza vaccines are inactivated vaccines in general and are permitted. Intranasal influenza vaccines are live vaccines and are prohibited.
• Received strong CYP3A4 inhibitors/inducers, or OATP1B1/OATP1B3 inhibitors within 14 days prior to the first study drug administration, or require continuous use of such agents throughout the study period.
• Adverse reactions from prior anti-tumor therapy have not recovered to Grade ≤1 per NCI CTCAE v6.0 (excluding toxicities judged by the Investigator to carry no safety risks, such as alopecia, Grade 2 peripheral neuropathy, hypothyroidism stabilized with hormone replacement therapy, etc.).
• History of or current central nervous system metastases and/or carcinomatous meningitis; current untreated spinal cord compression (excluding participants with previously diagnosed treated spinal cord compression with documented clinically stable symptoms for more than 2 weeks prior to screening).
• Active infection requiring intravenous anti-infective therapy within 14 days prior to the first study drug administration.
• Symptomatic moderate or severe ascites within 14 days prior to the first dose or at screening (excluding minor ascites only visible on imaging without clinical symptoms); or uncontrolled moderate or larger pleural effusion or pericardial effusion.
• Tumor thrombus involving both the main portal vein and left/right portal branches simultaneously; tumor thrombus involving both the main portal vein and superior mesenteric vein simultaneously; or tumor thrombus involving the inferior vena cava.
• Esophageal or gastric variceal bleeding secondary to portal hypertension, or any life-threatening bleeding event within 6 months prior to the first study drug administration (including events requiring blood transfusion, surgery, locoregional intervention, or sustained medical treatment); known severe esophageal/gastric varices on endoscopy without definitive treatment within 3 months prior to the first study drug administration; other gastrointestinal bleeding events, active gastric or duodenal ulcer within 28 days prior to screening.
• History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or intestinal obstruction within 6 months prior to the first study drug administration.
• Presence of severe unhealed wounds or untreated fractures at screening.
• Current interstitial pneumonia/interstitial lung disease; prior history of interstitial pneumonia/interstitial lung disease requiring corticosteroid treatment; or other pulmonary conditions that may interfere with the identification and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia, active pulmonary tuberculosis, etc.

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

Study Sites (1)

Harbin medical university Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab; sintilimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of three treatment arms: SYS6090 plus bevacizumab, SYS6090 plus bevacizumab and SYS6043, or bevacizumab plus sintilimab.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2031
• Last Updated: August 12, 2026

Record last verified: 2026-07

Locations

CN (1)