JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma

NCT06954467 | Recruiting Phase 2

• 1 other identifier: JS207-006-II-HCC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 12

Brief Summary

This open-label, multicenter phase II study was designed to evaluate the safety and efficacy of JS207 alone or in combination with JS007 as first-line treatment in subjects with advanced HCC. The subjects were all subjects with unresectable, locally advanced, recurrent, or metastatic HCC who had not received previous systemic therapy. Planned to enroll 43 to 72 subjects.The study was divided into two stages, dose exploration stage (3-12 cases) and random expansion stage (40-60 cases).After the dose exploration phase, a dose group was selected to enter the randomized expansion phase based on comprehensive discussion and evaluation of DLT, AE, dose adjustment, PK parameters and preliminary efficacy results in each dose group.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (4)

• AE

  All adverse events, regardless of relationship to the study drug, were reported from the time the study drug was started until 90 days after the last dose or the subject started a new antineoplastic therapy, whichever occurred first.

  up to 27 mouths

• SAE

  Only those resulting from interventions required by the protocol were reported from the time of ICF signing until the first dose. All were reported from the time of the first dose until 90 days after the last dose or initiation of a new antineoplastic therapy, after which, those considered to be related to previous study treatment were reported.

  up to 27 mouths

• DLT

  Dose-limiting toxicity

  up to 24 days after the first dose

• ORR

  Objective remission rate

  up to 27 mouths

Secondary Outcomes (7)

• PFS

  up to 27 mouths

• DCR

  up to 27 mouths

• DOR

  up to 27 mouths

• OS

  up to 27 mouths

• The trough concentrations（PK）

  up to 27 mouths

Study Arms (2)

JS207 Combined with JS007-ArmA

EXPERIMENTAL

Drug: JS207; Drug: JS007

JS207 monotherapy-ArmB

EXPERIMENTAL

Drug: JS207

Interventions

JS207 DRUG

10 mg/kg q3W or adjust the dose (e.g. 15 mg/kg) based on accumulated data on the safety and efficacy of JS207 from clinical studies.

JS207 Combined with JS007-ArmA; JS207 monotherapy-ArmB

JS007 DRUG

Dose exploration stage: C1-C4, group 1:3 mg/kg, C1D1 once (single dose); Group 2:3 mg/kg, D1, Q6W; Group 3:1 mg/kg,D1, Q3W; ≥C5, 1 mg/kg, Q6W; Dose expansion stage: according to the group medication confirmed in the dose exploration stage.

JS207 Combined with JS007-ArmA

Eligibility Criteria

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

You may qualify if:

• Willing to participate and sign a written informed consent form.
• Age ≥ 18 years, male or female.
• Patients with histologically/cytologically confirmed HCC or Hepatic cirrhosis meeting the criteria of the American Association for the Study of Liver Diseases (AASLD) can be enrolled.
• HCC classified as Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage) or stage C (advanced stage), or stage IIa/IIb or IIIa/IIIb as defined by the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition), prior to lymph node clearance, and deemed unsuitable for surgical and/or local treatment.
• No systemic therapy for HCC prior to study entry (mainly including systemic chemotherapy, targeted therapy, immunotherapy, etc.; adjuvant/neoadjuvant administration of small molecule anti-angiogenic drugs, such as lenvatinib, sorafenib, and donafenib, is allowed, but the last dose of these drugs must be administered ≥90 days prior to the first dose of the study drug).
• Having ≥1 measurable lesion according to RECIST v1.1. Requirement: The selected target lesion had not been subjected to local therapy previously, or the selected target lesion was located in the area of previous local therapy, but later determined to be progressed through imaging examination according to RECIST v1.1.
• Child-Pugh liver function class A or B ≤ 7 without history of Hepatic encephalopathy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
• Life expectancy ≥12 weeks.
• Major organ function meets the following requirements, without transfusion, hematopoietic stimulating factors (including G-CSF, GM-CSF, EPO and TPO, etc.) or human Albumin preparations within 14 days prior to screening:
• Females of childbearing potential and males whose partners are of childbearing age are required to use highly effective contraceptive measures during the trial and for at least 6 months after the last dose (Appendix 5). Female patients of childbearing potential must have a negative serum HCG test within 7 days before study entry and must be non-lactating.

You may not qualify if:

• Participants who meet any of the following criteria should be excluded from this study:
• Received major surgery (requiring general anesthesia and \>24 hours of hospitalization, excluding diagnostic biopsy), live vaccination, or investigational drug treatment within 4 weeks prior to the first dose, or received palliative radiotherapy for localized bone/brain lesions within 2 weeks prior to the first dose.
• Patients who are receiving chronic systemic corticosteroid therapy (daily dose \>10 mg prednisone or other glucocorticoid with the same effect) or other immunosuppression therapy within 7 days prior to the first dose.
• Hepatic tumor burden \> 50% of total hepatic volume at screening.
• Invasion of portal vein main trunk (Vp4) by cancer thrombus (more than 1/2 of lumen) as confirmed by CT/MRI examination.
• Presence of metastases to central nervous system of HCC; MRI scan of brain and/or spine is required to rule out the possibility when it is suspected.
• Toxicity induced by previous treatment (except for alopecia and Neuropathy peripheral) has not recovered to ≤ grade 1 (NCI-CTCAE v5.0).
• Severe infection during the screening period, including but not limited to hospitalization for infection, bacteraemia or severe pneumonia complications, oral or intravenous administration of therapeutic antibiotics for ≥7 days within 14 days prior to the first dose (patients receiving prophylactic antibiotics can be enrolled), fever ≥38.5°C of unknown origin within 7 days prior to the first dose or white blood cell count \>15×109/L at baseline.
• Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically evident moderate or severe peritoneal effusion during screening period is defined as meeting the following criteria: having clinical symptoms and detectable pericardial, pleural, and peritoneal effusion on physical examination; or pleural and peritoneal effusion requiring puncture and aspiration and/or intracavitary drug administration for treatment.
• Grade ≥3 (NCI-CTCAE v5.0) gastrointestinal or non-gastrointestinal fistula during screening period.
• Existence of severe unhealed wounds, active ulcer and Therapy naive fracture at screening period.
• Severe cardiovascular diseases.
• History of haemorrhage of digestive tract within 6 months prior to the first dose, or clear haemorrhagic diathesis (including high-risk severe esophageal-gastric varicose vein, local active digestive tract ulcer lesions, and persistent faecal occult blood positive; if faecal occult blood positive at baseline, it can be rechecked; if still positive after recheck, upper gastrointestinal endoscopy is required; if endoscopy indicates severe esophageal-gastric varicose vein or the investigator judges that there is a clear risk of bleeding, then the subject cannot be enrolled).
• Evidence of other haemorrhagic diathesis or significant coagulopathy.
• History of intestinal obstruction and/or clinical signs or symptoms of gastrointestinal tract obstruction within 6 months prior to the first dose, including incomplete obstruction associated with pre-existing diseases requiring routine parenteral hydration, parenteral nutrition, or enteral feeding (patients who received definite \[surgical\] treatment prior to the first dose to resolve the obstruction symptoms were allowed to be enrolled).

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (12)

The First Affiliated Hospital of USTC

Hefei, Anhui, 230022, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 451191, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110801, China

NOT YET RECRUITING

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 130061, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine City:Shanghai

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai East Hospital,School of Medicine, Tongji University

Shanghai, Shanghai Municipality, 200120, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Central Study Contacts

Jiazheng Yan, Master

CONTACT

+86 15822596147; jiazheng_yan@junshipharma.com

Feng Li, Master

CONTACT

+86 18627721499; feng_li@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 1, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)