NCT07484724

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
22mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Apr 2028

First Submitted

Initial submission to the registry

March 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

March 16, 2026

Last Update Submit

April 21, 2026

Conditions

Advanced Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (4)

  • dose-limiting toxicity （DLT）

    Abnormal changes in laboratory and other tests with clinical significance

    up to 4 years

  • adverse event（AE）

    Abnormal changes in laboratory and other tests with clinical significance

    up to 4 years

  • RP3D

    Recommended dose for phase III trial

    up to 4 years

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

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

    up to 4 years

Secondary Outcomes (3)

  • Progression free survival(PFS)

    up to 2years

  • overall survival (OS)

    up to 4 years

  • immunogenicity

    up to 2years

Other Outcomes (1)

  • Biomarker

    up to 2years

Study Arms (2)

Cohort 1:JS212+JS001

EXPERIMENTAL
Drug: JS212Drug: JS001

Cohort 2:JS212+JS001+5-FU

EXPERIMENTAL
Drug: JS212Drug: JS001Drug: 5-FU

Interventions

JS212DRUG

JS212 will be administered every 3 weeks

Cohort 1:JS212+JS001Cohort 2:JS212+JS001+5-FU
JS001DRUG

JS001 will be administered every 3 weeks

Cohort 1:JS212+JS001Cohort 2:JS212+JS001+5-FU
5-FUDRUG

5-FU will be administered on d1and d8 every 3 weeks

Cohort 2:JS212+JS001+5-FU

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 1.
  • Expected survival ≥ 12 weeks

You may not qualify if:

  • 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;
  • Severe cardiovascular or cerebrovascular disease;
  • Known hypersensitivity or severe allergic reaction to the study treatment drugs, any of their components, or their excipients；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Fluorouracil

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Chengbo Jia

CONTACT

+8618547265054chengbo_jia@junpharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 20, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)