NCT03281824 is a Phase 1 clinical trial of ALT-P7 (HM2-MMAE) in HER2-positive Breast Cancer, sponsored by Alteogen, Inc..

Who is sponsoring NCT03281824?

NCT03281824 is sponsored by Alteogen, Inc..

What drugs are being tested in NCT03281824?

Interventions in NCT03281824: ALT-P7 (HM2-MMAE).

What condition does NCT03281824 study?

NCT03281824 studies HER2-positive Breast Cancer.

Is NCT03281824 still recruiting?

NCT03281824 is currently completed. Last updated 18 January 2022.

Last reviewed 2022-01-18 · How we verify

NCT03281824

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

Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients

Completed Phase 1 Last updated 18 January 2022

What this trial tests

Phase 1 trial testing ALT-P7 (HM2-MMAE) in HER2-positive Breast Cancer in 27 participants. Completed in 15 January 2021.

Timeline

11 January 2018

Primary endpoint
12 March 2020

15 January 2021

Quick facts

Lead sponsor	Alteogen, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	27
Start date	11 January 2018
Primary completion	12 March 2020
Estimated completion	15 January 2021
Sites	1 location across South Korea

Drugs / interventions tested

ALT-P7 (HM2-MMAE) — full drug profile →

Conditions studied

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

Sponsor

Alteogen, Inc. — full company profile →

Who can join

19 and older, female only, with HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This open-label study assessed the safety, tolerability and pharmacokinetics of ALT-P7(HM2-Drug Conjugate) in patients with HER2-positive metastatic breast cancer who have progressed on previous Trastuzumab-based therapy. Patients received ALT-P7(0.3 mg/kg\~5.4 mg/kg, 7 groups) intravenously on Day 1 of each 3-week cycle.

Publications & conference data

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

Targeting HER2-positive breast cancer: advances and future directions.
Swain SM, Shastry M, Hamilton E. · · 2023 · cited 703× · PMID 36344672 · DOI 10.1038/s41573-022-00579-0
Antibody-Drug Conjugates for Cancer Therapy.
Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764
Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: state of the art and future directions.
Ferraro E, Drago JZ, Modi S. · · 2021 · cited 164× · PMID 34380530 · DOI 10.1186/s13058-021-01459-y
HER2 Directed Antibody-Drug-Conjugates beyond T-DM1 in Breast Cancer.
Rinnerthaler G, Gampenrieder SP, Greil R. · · 2019 · cited 157× · PMID 30841523 · DOI 10.3390/ijms20051115
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
Marine Natural Products in Clinical Use.
Haque N, Parveen S, Tang T, Wei J, et al · · 2022 · cited 101× · PMID 36005531 · DOI 10.3390/md20080528
Emerging Targeted Therapies for HER2-Positive Breast Cancer.
Mercogliano MF, Bruni S, Mauro FL, Schillaci R. · · 2023 · cited 95× · PMID 37046648 · DOI 10.3390/cancers15071987
Resistance to antibody-drug conjugates in breast cancer: mechanisms and solutions.
Chen YF, Xu YY, Shao ZM, Yu KD. · · 2023 · cited 93× · PMID 36357174 · DOI 10.1002/cac2.12387

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 Alteogen, Inc. trials

Trials by the same sponsor.

NCT05232175 — Clinical Study of ALT-BB4 to Determine Tolerance, Safety and Pharmacokinetics in Healthy Volunteer · Phase 1 · completed
NCT04058535 — Clinical Study of ALT-L9 to Determine Safety, Efficacy and Pharmacokinetics in Neovascular AMD · Phase 1 · completed
NCT03242239 — A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects · Phase 1 · 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 NCT03281824 (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 Alteogen, Inc.
Last refreshed: 18 January 2022

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/NCT03281824.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing