A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma

Shanghai Junshi Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Advanced Esophageal Squamous Cell Carcinoma

Treatments: Drug: JS212; Drug: 5-FU; Drug: JS001

Study type: Interventional

Funder types: Other

Identifiers

NCT07484724

JS212-006-II-ESCC

Details and patient eligibility

About

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).

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects aged 18 to 75 years (inclusive) at the time of signing the Informed Consent Form (ICF).
2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC) that is locally advanced, recurrent, or metastatic, and not amenable to radical treatment.
3. 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.
4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Expected survival ≥ 12 weeks

Exclusion criteria

1. 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;
2. 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;
3. Subjects with a history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose;
4. Presence of active central nervous system (CNS) metastases;
5. Active autoimmune disease requiring systemic therapy (e.g., corticosteroids or immunosuppressive agents) within 2 years prior to the first dose;
6. 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;
7. Severe cardiovascular or cerebrovascular disease;
8. Known hypersensitivity or severe allergic reaction to the study treatment drugs, any of their components, or their excipients；

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Cohort 1:JS212+JS001

Experimental group

Treatment:

Drug: JS001

Drug: JS212

Cohort 2:JS212+JS001+5-FU

Experimental group

Treatment:

Drug: JS001

Drug: 5-FU

Drug: JS212