NCT03872791 is a Phase 1, PHASE2 clinical trial of KN046 in Triple-negative Breast Cancer, sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.

Who is sponsoring NCT03872791?

NCT03872791 is sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.

What drugs are being tested in NCT03872791?

Interventions in NCT03872791: KN046, Nab-paclitaxel.

What condition does NCT03872791 study?

NCT03872791 studies Triple-negative Breast Cancer.

Is NCT03872791 still recruiting?

NCT03872791 is currently completed. Last updated 8 June 2023.

Last reviewed 2023-06-08 · How we verify

NCT03872791

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

A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer

Completed Phase 1, PHASE2 Last updated 8 June 2023

What this trial tests

Phase 1, PHASE2 trial testing KN046 in Triple-negative Breast Cancer in 52 participants. Completed in 27 October 2022.

Timeline

30 May 2019

Primary endpoint
16 August 2022

27 October 2022

Quick facts

Lead sponsor	Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	30 May 2019
Primary completion	16 August 2022
Estimated completion	27 October 2022
Sites	12 locations across China

Drugs / interventions tested

KN046 — full drug profile →
Nab-paclitaxel (nab-paclitaxel) — full drug profile →

Conditions studied

Triple-negative Breast Cancer — all drugs for Triple-negative Breast Cancer →

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd — full company profile →

Who can join

18 and older, any sex, with Triple-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, phase Ib/II, multi-center study to evaluate efficacy and safety of KN046 alone or in combination with nab-paclitaxel in subjects with locally advanced unresectable or metastatic triple negative breast cancer (TNBC). The study is composed of dose escalation and expansion parts. Every subject will subject tumor tissue used for biomarker evaluation. Each subject will receive KN046 or in combination with nab-paclitaxel untill confirmed progressive disease, unacceptable toxicity or withdrawal of informed consent whichever occurs first.

Publications & conference data

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

Recent advances in therapeutic strategies for triple-negative breast cancer.
Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0
Emerging new therapeutic antibody derivatives for cancer treatment.
Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x
Practical classification of triple-negative breast cancer: intratumoral heterogeneity, mechanisms of drug resistance, and novel therapies.
Marra A, Trapani D, Viale G, Criscitiello C, et al · · 2020 · cited 209× · PMID 33088912 · DOI 10.1038/s41523-020-00197-2
The Characteristics of Tumor Microenvironment in Triple Negative Breast Cancer.
Fan Y, He S. · · 2022 · cited 95× · PMID 35018117 · DOI 10.2147/cmar.s316700
Recruitment and Expansion of Tregs Cells in the Tumor Environment-How to Target Them?
Cinier J, Hubert M, Besson L, Di Roio A, et al · · 2021 · cited 83× · PMID 33924428 · DOI 10.3390/cancers13081850
Biology drives the discovery of bispecific antibodies as innovative therapeutics.
Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003
Immunotherapy for Triple-Negative Breast Cancer: Combination Strategies to Improve Outcome.
Li L, Zhang F, Liu Z, Fan Z. · · 2023 · cited 73× · PMID 36612317 · DOI 10.3390/cancers15010321
The anti-PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel in first-line treatment of metastatic triple-negative breast cancer: a multicenter phase II trial.
Li Q, Liu J, Zhang Q, Ouyang Q, et al · · 2024 · cited 61× · PMID 38310192 · DOI 10.1038/s41467-024-45160-y

Verify or expand the search:

Other trials of KN046

Trials testing the same drug.

NCT05832892 — Surufatinib Combined With KN046 and AG Regimen Chemotherapy as First-Line Treatment for Unresectable Advanced Pancreatic · Phase 1, PHASE2 · unknown
NCT05985109 — KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer · Phase 2 · recruiting
NCT06099821 — KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade · Phase 2 · recruiting
NCT06023758 — Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC · Phase 2 · recruiting
NCT05985707 — KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma · Phase 2 · not yet recruiting

Other recruiting trials for Triple-negative Breast Cancer

Currently open trials in the same condition.

NCT07510802 — Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC · Phase 1, PHASE2 · recruiting
NCT07045311 — JS207 Combination Therapy in Triple-negative Breast Cancer · Phase 2 · recruiting
NCT06078384 — Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC · Phase 2 · recruiting
NCT06817525 — Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC · Phase 2 · recruiting
NCT06371274 — A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC. · NA · recruiting

Other Jiangsu Alphamab Biopharmaceuticals Co., Ltd trials

Trials by the same sponsor.

NCT07533123 — A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who H · Phase 3 · recruiting
NCT07391644 — A Study of JSKN027 in Patients With Advanced Solid Tumors · Phase 1 · not yet recruiting
NCT07475559 — JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors · Phase 1 · not yet recruiting
NCT07283198 — A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients Wit · Phase 2 · not yet recruiting
NCT07292402 — JSKN022 in Subjects With Advanced Malignant Solid Tumors · Phase 1 · 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 NCT03872791 (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 Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Last refreshed: 8 June 2023

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