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RC48-ADC
RC48-ADC is an antibody-drug conjugate that targets HER2-positive cancer cells by delivering cytotoxic payload directly to tumor cells expressing the HER2 receptor.
RC48-ADC is an antibody-drug conjugate that targets HER2-positive cancer cells by delivering cytotoxic payload directly to tumor cells expressing the HER2 receptor. Used for HER2-positive gastric cancer, HER2-positive breast cancer, HER2-positive biliary tract cancer.
At a glance
| Generic name | RC48-ADC |
|---|---|
| Also known as | RC48-ADC injection, Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection, RC48, Disitamab Vedotin, Disitamab vedotin |
| Sponsor | RemeGen Co., Ltd. |
| Drug class | HER2-targeted antibody-drug conjugate |
| Target | HER2 (human epidermal growth factor receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
RC48-ADC combines a humanized anti-HER2 monoclonal antibody with a microtubule-disrupting cytotoxic agent (monomethyl auristatin E, MMAE) via a cleavable linker. The antibody binds to HER2 on cancer cell surfaces, enabling internalization and release of the toxic payload within tumor cells, leading to cell cycle arrest and apoptosis while sparing HER2-negative cells.
Approved indications
- HER2-positive gastric cancer
- HER2-positive breast cancer
- HER2-positive biliary tract cancer
Common side effects
- Peripheral neuropathy
- Nausea
- Fatigue
- Thrombocytopenia
- Anemia
Key clinical trials
- Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 (PHASE3)
- A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer (PHASE1, PHASE2)
- A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors (PHASE2)
- Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC (PHASE2)
- A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 (PHASE2)
- RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure (PHASE2, PHASE3)
- A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 (PHASE2)
- Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC) (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- RC48-ADC CI brief — competitive landscape report
- RC48-ADC updates RSS · CI watch RSS
- RemeGen Co., Ltd. portfolio CI