Trials / Unknown
UnknownNCT06000033
Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer
Combination of Disitamab Vedotin and Anlotinib in the Treatment of HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer: A Single-Arm, Multicenter, Phase II Clinical Study
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- Sponsor
- Qilu Hospital of Shandong University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Disitamab Vedotin (RC48) contains the novel humanized anti-HER2 antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable linker , which is the first ADC drug that was independently developed by Rongchang Biology .The aim of this study is to evaluate the efficacy and safety of RC48 in Combination with Anlotinib for the treatment of metastatic breast cancer with HR negativity and HER2 low expression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Disitamab Vedotin+Anlotinib | Disitamab Vedotin:2 mg/kg，ivgtt，d1-14/28day/cycle Anlotinib: 12mg once daily (taken before meals) orally, continuously for 2 weeks followed by a 1-week break. Each cycle consists of 21 days. |
Timeline
- Start date
- 2023-08-10
- Primary completion
- 2024-12-31
- Completion
- 2025-12-31
- First posted
- 2023-08-21
- Last updated
- 2023-08-21
Source: ClinicalTrials.gov record NCT06000033. Inclusion in this directory is not an endorsement.