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Clinical Trials/NCT07484724
NCT07484724
Recruiting
Phase 2

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (ESCC)

Shanghai Junshi Bioscience Co., Ltd.2 sites in 1 country280 target enrollmentStarted: April 13, 2026Last updated:
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InterventionsJS001JS2125-FU

Overview

Phase
Phase 2
Status
Recruiting
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Enrollment
280
Locations
2
Primary Endpoint
dose-limiting toxicity （DLT）
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study is an open-label, multi-center phase II clinical trial aimed to evaluat the safety and preliminary efficacy of JS212 combination therapy in patients with advanced esophageal squamous cell carcinoma (ESCC).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or female subjects aged 18 to 75 years (inclusive) at the time of signing the Informed Consent Form (ICF).
  • •Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC) that is locally advanced, recurrent, or metastatic, and not amenable to radical treatment.
  • •No prior systemic anti-tumor therapy. For patients who received neoadjuvant/adjuvant therapy or radical concurrent chemoradiotherapy, the interval from the last dose of chemotherapy to disease recurrence or progression must be \> 6 months to be eligible for screening.
  • •At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
  • •Expected survival ≥ 12 weeks

Exclusion Criteria

  • •Prior treatment with any of the following: anti-PD-1 or anti-PD-L1 antibody therapy; ADC therapy targeting EGFR and/or HER3, or ADC therapy with a topoisomerase I inhibitor as the toxic payload;
  • •Subjects at high risk of bleeding or esophageal fistula, e.g., lesions with large ulcers or direct invasion of vital adjacent organs such as the aorta or trachea;
  • •Subjects with a history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose;
  • •Presence of active central nervous system (CNS) metastases;
  • •Active autoimmune disease requiring systemic therapy (e.g., corticosteroids or immunosuppressive agents) within 2 years prior to the first dose;
  • •Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v6.0 or to the level specified in the inclusion/exclusion criteria;
  • •Severe cardiovascular or cerebrovascular disease;
  • •Known hypersensitivity or severe allergic reaction to the study treatment drugs, any of their components, or their excipients；

Arms & Interventions

Cohort 2:JS212+JS001+5-FU

Experimental

Intervention: JS001 (Drug)

Cohort 1:JS212+JS001

Experimental

Intervention: JS212 (Drug)

Cohort 2:JS212+JS001+5-FU

Experimental

Intervention: JS212 (Drug)

Cohort 2:JS212+JS001+5-FU

Experimental

Intervention: 5-FU (Drug)

Cohort 1:JS212+JS001

Experimental

Intervention: JS001 (Drug)

Outcomes

Primary Outcomes

dose-limiting toxicity （DLT）

Time Frame: up to 4 years

Abnormal changes in laboratory and other tests with clinical significance

adverse event（AE）

Time Frame: up to 4 years

Abnormal changes in laboratory and other tests with clinical significance

RP3D

Time Frame: up to 4 years

Recommended dose for phase III trial

Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)

Time Frame: up to 4 years

Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)

Secondary Outcomes

  • Progression free survival(PFS)(up to 2years)
  • overall survival (OS)(up to 4 years)
  • immunogenicity(up to 2years)

Investigators

Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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