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Compound · clinical trials

JS001 clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 25 trials in our China, USA, Canada and Australia registers that name JS001 as an intervention. Synced 29 Sep 2026
25Current trials
16Recruiting now
11Lead sponsors
4Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

JS001 is named as an intervention in 25 current clinical trials in our China, USA, Canada and Australia registers. 16 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is RemeGen Co., Ltd (7). The most-studied condition is Breast Cancer.

Trials by status

  • Recruiting1664%
  • Not yet open416%
  • Active, closed520%

Trials by phase

  • Phase 21456%
  • Phase 3416%
  • Phase 2/3312%
  • Phase 1/228%
  • Phase 414%
  • Phase 114%
01

Clinical trials of JS001

25 trials
StudyPhaseStatusLead sponsorRegisters
A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
NCT06457503 · ClinicalTrials.gov ↗ · Nasopharyngeal Cancer Recurrent
Phase 4 Recruiting Coherus Oncology, Inc USA, Canada
PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients
NCT03907826 · ClinicalTrials.gov ↗ · Recurrent Nasopharyngeal Carcinoma
Phase 3 Recruiting Sun Yat-sen University China
Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma
NCT04376866 · ClinicalTrials.gov ↗ · Recurrent Nasopharyngeal Carcinoma
Phase 3 Recruiting Cancer Hospital of Guangxi Medical University China
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
NCT05302284 · ClinicalTrials.gov ↗ · Urothelial Carcinoma, HER2-expressing
Phase 3 Recruiting RemeGen Co., Ltd China
Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC
NCT07177794 · ClinicalTrials.gov ↗ · Esophageal Cancer, Chemoradiotherapy
Phase 3 Recruiting Sun Yat-sen University China
PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer
NCT05033392 · ClinicalTrials.gov ↗ · Stomach Neoplasms
Phase 2 Recruiting Wan He China
Modulation Therapy for Locally Advanced NPC Based on Plasma EBV DNA Level Post-ICT
NCT05628922 · ClinicalTrials.gov ↗ · Nasopharyngeal Cancer
Phase 2 Recruiting Fudan University China
Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.
NCT06155383 · ClinicalTrials.gov ↗ · Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Phase 2 Recruiting RemeGen Co., Ltd China
DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer
NCT06178159 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Recruiting RemeGen Co., Ltd China
Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
NCT06227117 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Recruiting RemeGen Co., Ltd China
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ยฑ Toripalimab in HR-/HER2-low Breast Cancer
NCT06642545 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Recruiting RemeGen Co., Ltd China
Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
NCT06705127 · ClinicalTrials.gov ↗ · HR-positive,HER2-negative Breast Cancer
Phase 2 Recruiting First Affiliated Hospital of Zhejiang University China
9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
NCT06823427 · ClinicalTrials.gov ↗ · Urothelial Carcinoma, Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
Phase 2 Recruiting Mabwell (Shanghai) Bioscience Co., Ltd China
A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma
NCT07484724 · ClinicalTrials.gov ↗ · Advanced Esophageal Squamous Cell Carcinoma
Phase 2 Recruiting Shanghai Junshi Bioscience Co., Ltd China
Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder Cancer
NCT07717242 · ClinicalTrials.gov ↗ · Bladder Urothelial Carcinoma, Bladder Cancer
Phase 2 Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University China
A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors
NCT06038396 · ClinicalTrials.gov ↗ · Advanced Solid Tumor
Phase 1/2 Recruiting RemeGen Co., Ltd China
An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC
NCT04890522 · ClinicalTrials.gov ↗ · Nasopharyngeal Carcinoma, Metastasis, Chemotherapy
Phase 2/3 Not yet open Sun Yat-sen University China
Toripalimab Adjuvant Therapy in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Complete Response (pCR)
NCT06903871 · ClinicalTrials.gov ↗ · Esophageal Squamous Cell Carcinoma Stage II, Esophageal Squamous Cell Carcinoma Stage III
Phase 2 Not yet open Hebei Medical University Fourth Hospital China
Oncolytic Virus H101 Combined With Lenvatinib Plus Toripalimab Compared With FOLFOX in Patients With Advanced Biliary Tract Cancer (OPTIONS-06)
NCT06919848 · ClinicalTrials.gov ↗ · Biliary Tract Cancer (BTC)
Phase 2 Not yet open Fudan University China
Newly Emerging Immunotherapy for Pancreatic Cancer Treatment
NCT06370754 · ClinicalTrials.gov ↗ · Pancreatic Cancer
Phase 1/2 Not yet open Fudan University China
Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection
NCT03859128 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma
Phase 2/3 Active, closed Shanghai Junshi Bioscience Co., Ltd China
A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
NCT05980481 · ClinicalTrials.gov ↗ · Gastric Cancer
Phase 2/3 Active, closed RemeGen Co., Ltd China
Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma
NCT03930498 · ClinicalTrials.gov ↗ · Recurrent Nasopharyngeal Carcinoma
Phase 2 Active, closed Sun Yat-sen University China
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
NCT05975307 · ClinicalTrials.gov ↗ · Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor, Radiotherapy
Phase 2 Active, closed Sun Yat-sen University China
Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors
NCT06571422 · ClinicalTrials.gov ↗ · Advanced Malignant Solid Tumors
Phase 1 Active, closed Shanghai Junshi Bioscience Co., Ltd China, Australia

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with JS001

32 conditions
Breast Cancer3Recurrent Nasopharyngeal Carcinoma3Urothelial Carcinoma2Gastric Cancer2Nasopharyngeal Cancer Recurrent1Stomach Neoplasms1Advanced Malignant Solid Tumors1Esophageal Squamous Cell Carcinoma Stage II1Esophageal Squamous Cell Carcinoma Stage III1HER2-expressing1Gastroesophageal Junction Adenocarcinoma1Bladder Urothelial Carcinoma1
All 32 conditions
Condition (as registered)Trials
Breast Cancer3
Recurrent Nasopharyngeal Carcinoma3
Urothelial Carcinoma2
Gastric Cancer2
Nasopharyngeal Cancer Recurrent1
Stomach Neoplasms1
Advanced Malignant Solid Tumors1
Esophageal Squamous Cell Carcinoma Stage II1
Esophageal Squamous Cell Carcinoma Stage III1
HER2-expressing1
Gastroesophageal Junction Adenocarcinoma1
Bladder Urothelial Carcinoma1
Bladder Cancer1
Pancreatic Cancer1
Biliary Tract Cancer (BTC)1
Advanced Solid Tumor1
Muscle-Invasive Bladder Carcinoma1
Programmed Cell Death Protein 1 Inhibitor1
Radiotherapy1
Esophageal Cancer1
Chemoradiotherapy1
Hepatocellular Carcinoma1
Nasopharyngeal Carcinoma1
Metastasis1
Chemotherapy1
Immunotherapy1
HR-positive,HER2-negative Breast Cancer1
Urothelial Carcinoma Bladder1
Urothelial Carcinoma Recurrent1
Urothelial Carcinoma of the Renal Pelvis and Ureter1
Nasopharyngeal Cancer1
Advanced Esophageal Squamous Cell Carcinoma1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
RemeGen Co., Ltd7
Sun Yat-sen University5
Shanghai Junshi Bioscience Co., Ltd3
Fudan University3
Coherus Oncology, Inc1
Wan He1
Hebei Medical University Fourth Hospital1
Cancer Hospital of Guangxi Medical University1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1
First Affiliated Hospital of Zhejiang University1
Mabwell (Shanghai) Bioscience Co., Ltd1
04

By country register

RegisterTrialsRecruiting
Clinical trials in China2415
Clinical trials in USA11
Clinical trials in Canada11
Clinical trials in Australia10

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about JS001 trials

How many clinical trials are testing JS001?

25 current trials in our China, USA, Canada and Australia registers name JS001 as a drug or biological intervention, as of the registry sync on 29 September 2026. Completed and withdrawn studies are not counted.

Are JS001 trials recruiting patients?

Yes. 16 of the 25 trials are recruiting: 15 with sites in China, 1 with sites in USA and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors JS001 clinical trials?

RemeGen Co., Ltd (7), Sun Yat-sen University (5), Shanghai Junshi Bioscience Co., Ltd (3) and Fudan University (3), among 11 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how JS001 works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how JS001 works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists JS001 (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 29 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.