Who is sponsoring NCT03953833?

NCT03953833 is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd.

What condition does NCT03953833 study?

NCT03953833 studies HER2-positive Breast Cancer.

Is NCT03953833 still recruiting?

NCT03953833 is currently completed. Last updated 14 September 2023.

Last reviewed 2023-09-14 · How we verify

NCT03953833: B003-101

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

B003 in Patients With HER2-positive Recurrent or Metastatic Breast Cancer

Completed Phase 1 Last updated 14 September 2023

What this trial tests

Phase 1 trial testing Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003. in HER2-positive Breast Cancer in 30 participants. Completed in 13 January 2023.

Timeline

1 April 2019

Primary endpoint
13 January 2023

13 January 2023

Quick facts

Lead sponsor	Shanghai Pharmaceuticals Holding Co., Ltd
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 April 2019
Primary completion	13 January 2023
Estimated completion	13 January 2023
Sites	1 location across China

Drugs / interventions tested

Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003. — full drug profile →

Conditions studied

HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd — full company profile →

Who can join

Adults 18 to 75, female only, with HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To assess the safety and tolerability characteristics of B003 in HER2-positive patients with recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) is assessed and the maximum tolerated dose (MTD) is explored.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antibody-Drug Conjugates for Cancer Therapy.
Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764
Targeting cancer with antibody-drug conjugates: Promises and challenges.
Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427
Antibody-Drug Conjugates for the Treatment of HER2-Positive Breast Cancer.
Najjar MK, Manore SG, Regua AT, Lo HW. · · 2022 · cited 65× · PMID 36360302 · DOI 10.3390/genes13112065
Novel ADCs and Strategies to Overcome Resistance to Anti-HER2 ADCs.
Díaz-Rodríguez E, Gandullo-Sánchez L, Ocaña A, Pandiella A. · · 2021 · cited 65× · PMID 35008318 · DOI 10.3390/cancers14010154
Clinical perspective: Antibody-drug conjugates for the treatment of HER2-positive breast cancer.
Najminejad Z, Dehghani F, Mirzaei Y, Mer AH, et al · · 2023 · cited 45× · PMID 36950736 · DOI 10.1016/j.ymthe.2023.03.019
Novel development strategies and challenges for anti-Her2 antibody-drug conjugates.
Zhang X, Huang AC, Chen F, Chen H, et al · · 2022 · cited 24× · PMID 35146330 · DOI 10.1093/abt/tbac001
Antibody drug conjugates in the clinic.
Udofa E, Sankholkar D, Mitragotri S, Zhao Z. · · 2024 · cited 12× · PMID 39545074 · DOI 10.1002/btm2.10677
Systemic Therapies for HER2-Positive Advanced Breast Cancer.
Angelis V, Okines AFC. · · 2023 · cited 4× · PMID 38201451 · DOI 10.3390/cancers16010023

Verify or expand the search:

Other recruiting trials for HER2-positive Breast Cancer

Currently open trials in the same condition.

NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
NCT07377643 — IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer · Phase 3 · recruiting
NCT07510802 — Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC · Phase 1, PHASE2 · recruiting
NCT07486089 — Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC) · Phase 1, PHASE2 · recruiting
NCT07102381 — A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Ca · Phase 2 · recruiting

Other Shanghai Pharmaceuticals Holding Co., Ltd trials

Trials by the same sponsor.

NCT06839131 — A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects. · Phase 1 · recruiting
NCT06487455 — A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors. · Phase 1 · recruiting
NCT06434597 — A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patient · Phase 2 · recruiting
NCT06483373 — A Clinical Study of SPH7854 Granules in Healthy Subjects. · EARLY_PHASE1 · recruiting
NCT05046314 — A Clinical Study of TK216 in Patients With Relapsed or Refractory Ewing's Sarcoma · Phase 2 · completed

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 NCT03953833 (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 Shanghai Pharmaceuticals Holding Co., Ltd
Last refreshed: 14 September 2023

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/NCT03953833.

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