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JS004 in combination with toripalimab
JS004 is a CTLA-4 inhibitor that blocks immune checkpoint signaling, and when combined with toripalimab (a PD-1 inhibitor), it provides dual checkpoint blockade to enhance anti-tumor immune responses.
JS004 is a CTLA-4 inhibitor that blocks immune checkpoint signaling, and when combined with toripalimab (a PD-1 inhibitor), it provides dual checkpoint blockade to enhance anti-tumor immune responses. Used for Advanced or metastatic solid tumors (Phase 3 development).
At a glance
| Generic name | JS004 in combination with toripalimab |
|---|---|
| Also known as | JS004+JS001 |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. |
| Drug class | CTLA-4 inhibitor (in combination with PD-1 inhibitor) |
| Target | CTLA-4 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
JS004 blocks CTLA-4, a negative regulator of T-cell activation, while toripalimab blocks PD-1, another inhibitory checkpoint. Together, they remove multiple brakes on the immune system, allowing T cells to more effectively recognize and attack cancer cells. This dual checkpoint inhibition approach is designed to overcome resistance to single-agent immunotherapy.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Immune-related adverse events (irAEs) including colitis, pneumonitis, hepatitis
- Fatigue
- Rash
- Diarrhea
Key clinical trials
- A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors (PHASE1)
- JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer (PHASE1, PHASE2)
- A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy (PHASE2)
- A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC). (PHASE2)
- A Phase III Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL) (PHASE3)
- Study of JS004 Combined With Toripalimab for Advanced Lung Cancer (PHASE1, PHASE2)
- Combination of Toripalimab and JS004 Therapy for ccRCC (PHASE2)
- Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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