Advanced Esophageal Squamous Cell Carcinoma
Conditions
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).
Interventions
DRUGJS212
JS212 will be administered every 3 weeks
DRUGJS001
JS001 will be administered every 3 weeks
DRUG5-FU
5-FU will be administered on d1and d8 every 3 weeks
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dose-limiting toxicity （DLT） | up to 4 years | Abnormal changes in laboratory and other tests with clinical significance |
| adverse event（AE） | up to 4 years | Abnormal changes in laboratory and other tests with clinical significance |
| RP3D | 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) | up to 4 years | Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) | up to 2years | The time from first dose to Disease progression or death |
| overall survival (OS) | up to 4 years | The time from first dose to death from any cause |
| immunogenicity | up to 2years | Incidence of Anti-Drug Antibody (ADA) |
Countries
China
Contacts
CONTACTChengbo Jia
Outcome results
None listed