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NCT06105008
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
Withdrawn
Phase 2
Last updated 23 August 2024
What this trial tests
Phase 2 trial testing Disitamab Vedotin in Breast Neoplasms. Withdrawn.
Timeline
20 December 2024
Primary endpoint
20 December 2025
20 December 2025
10 April 2026
Quick facts
| Lead sponsor | RemeGen Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 20 December 2024 |
| Primary completion | 20 December 2025 |
| Estimated completion | 10 April 2026 |
| Sites | 3 locations across China |
Drugs / interventions tested
- Disitamab Vedotin (disitamab-vedotin) — full drug profile →
- Toripalimab (TORIPALIMAB) — full drug profile →
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
Sponsor
RemeGen Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast cancer.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Novel HER-2 Targeted Therapies in Breast Cancer.
Fernandes CL, Silva DJ, Mesquita A. · · 2023 · cited 9× · PMID 38201515 · DOI 10.3390/cancers16010087 -
Immunotherapy and its racial specificity for breast cancer treatment in Asia: a narrative review.
Xu RC, Zhang YW, Liu CC, Xu YY, et al · · 2025 · cited 3× · PMID 40443538 · DOI 10.1016/j.lanwpc.2024.101180 -
Diagnostic and therapeutic advances for HER2-expressing or amplified gynecologic cancers.
Lee EK, Kolin DL, Matulonis UA, Erickson BK. · · 2025 · cited 3× · PMID 40117942 · DOI 10.1016/j.ygyno.2025.03.011 -
Efficacy and safety of systemic therapies following progression on CDK4/6 inhibitors in patients with HR+/HER2- metastatic breast cancer: a systematic review and network meta-analysis.
Buonaiuto R, Fordellone M, Caltavituro A, Cataldo ML, et al · · 2025 · PMID 41079023 · DOI 10.1016/j.eclinm.2025.103535 -
Recent advances of antibody-drug conjugates in treating breast cancer with different HER2 status.
Qiu Y, Shi Y, Chao Z, Zhu X, et al · · 2025 · PMID 39759831 · DOI 10.1177/17588359241311379
Verify or expand the search:
- PubMed search for NCT06105008
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Disitamab Vedotin
Trials testing the same drug.
- NCT07474064 — Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC · Phase 2 · not yet recruiting
- NCT07366840 — RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure · Phase 2, PHASE3 · not yet recruiting
- NCT07315750 — A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab Wi · Phase 3 · recruiting
- NCT07142200 — A Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin Combined With PD-1 Inhibitor and Radiotherapy a · Phase 2 · not yet recruiting
- NCT07159217 — Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer · Phase 2 · not yet recruiting
Other recruiting trials for Breast Neoplasms
Currently open trials in the same condition.
- NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer · NA · recruiting
- NCT07500428 — Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models · recruiting
- NCT07581834 — Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multic · Phase 2 · recruiting
- NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) · Phase 2 · recruiting
- NCT07465393 — Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors · NA · recruiting
Other RemeGen Co., Ltd. trials
Trials by the same sponsor.
- NCT07537881 — A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors · Phase 1, PHASE2 · not yet recruiting
- NCT07462143 — A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer · Phase 2, PHASE3 · not yet recruiting
- NCT07495033 — Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related I · Phase 3 · not yet recruiting
- NCT07416474 — RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Smal · Phase 3 · not yet recruiting
- NCT07249632 — A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG) · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT06105008 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RemeGen Co., Ltd.
- Last refreshed: 23 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06105008.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing