Open-Label, Dose Increase and Phase I Study of ALT-P7 to Determine Safety, Tolerability, Pharmacokinetics for HER2 Positive Metastatic Breast Cancer Patients Who Have Progressed on Previous Trastuzumab-Based Therapy

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.

Start Date11 Jan 2018

Sponsor / Collaborator

Alteogen, Inc.

100 Clinical Results associated with ALT-P7

100 Translational Medicine associated with ALT-P7

100 Patents (Medical) associated with ALT-P7

Literatures (Medical) associated with ALT-P7

Frontiers in Molecular BiosciencesQ3 · BIOLOGY

Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers

Q3 · BIOLOGY

ReviewOA

Author: Liu, Xue ; Cai, Xiaoqing ; Yu, Jinfeng ; Fang, Tong ; Yun, Chengyu

Members of the human epidermal growth factor receptor (HER) family, which includes HER1 (also known as EGFR), HER2, HER3 and HER4, have played a central role in regulating cell proliferation, survival, differentiation and migration. The overexpression of the HER family has been recognized as one of the most common cellular dysregulation associated with a wide variety of tumor types. Antibody-drug conjugates (ADCs) represent a new and promising class of anticancer therapeutics that combine the cancer specificity of antibodies with cytotoxicity of chemotherapeutic drugs. Two HER2-directed ADCs, trastuzumane-emtansine (T-DM1) and trastuzumab-deruxtecan (DS-8201a), have been approved for HER2-positive metastatic breast cancer by the U.S. Food and Drug Administration (FDA) in 2013 and 2019, respectively. A third HER2-directed ADC, disitamab vedotin (RC48), has been approved for locally advanced or metastatic gastric or gastroesophageal junction cancer by the NMPA (National Medical Products Administration) of China in 2021. A total of 11 ADCs that target HER family receptors (EGFR, HER2 or HER3) are currently under clinical trials. In this review article, we summarize the three approved ADCs (T-DM1, DS-8201a and RC48), together with the investigational EGFR-directed ADCs (ABT-414, MRG003 and M1231), HER2-directed ADCs (SYD985, ARX-788, A166, MRG002, ALT-P7, GQ1001 and SBT6050) and HER3-directed ADC (U3-1402). Lastly, we discuss the major challenges associated with the development of ADCs, and highlight the possible future directions to tackle these challenges.

Frontiers in Pharmacology

From seaside to bedside: Current evidence and future perspectives in the treatment of breast cancer using marine compounds

Review

Author: Tancredi, Richard ; De Sanctis, Rita ; Santoro, Armando ; Zambelli, Alberto ; Franceschini, Raul ; Gaudio, Mariangela ; Pedrazzoli, Paolo ; Benvenuti, Chiara ; Jacobs, Flavia

To date, only few marine natural compounds have been proved to be active in breast cancer (BC). The main marine-derived drugs that have been studied for the treatment of BC are tubulin-binding agents (eribulin and plocabulin), DNA-targeting agents (cytarabine and minor groove binders—trabectedin and lurbinectedin) and Antibody-Drug Conjugates (ADCs). Notably, eribulin is the only approved cytotoxic drug for the treatment of advanced BC (ABC), while cytarabine has a limited indication in case of leptomeningeal diffusion of the disease. Also plocabulin showed limited activity in ABC but further research is needed to define its ultimate potential role. The available clinical data for both trabectedin and lurbinectedin are of particular interest in the treatment of BRCA-mutated tumours and HR deficient disease, probably due to a possible immune-mediated mechanism of action. One of the most innovative therapeutic options for the treatment of BC, particularly in TNBC and HER2-positive BC, are ADCs. Some of the ADCs were developed using a specific marine-derived cytotoxic molecule as payload called auristatin. Among these, clinical data are available on ladiratuzumab vedotin and glembatumumab vedotin in TNBC, and on disitamab vedotin and ALT-P7 in HER2-positive patients. A deeper knowledge of the mechanism of action and of the potential predictive factors for response to marine-derived drugs is important for their rational and effective use, alone or in combination. In this narrative review, we discuss the role of marine-derived drugs for the treatment of BC, although most of them are not approved, and the opportunities that could arise from the potential treasure trove of the sea for novel BC therapeutics.

International Journal of Molecular SciencesQ2 · BIOLOGY

HER2 Directed Antibody-Drug-Conjugates beyond T-DM1 in Breast Cancer

Q2 · BIOLOGY

ReviewOA

Author: Gampenrieder, Simon Peter ; Greil, Richard ; Rinnerthaler, Gabriel

Since the discovery of the human epidermal growth factor receptor 2 (HER2) as an oncogenic driver in a subset of breast cancers and the development of HER2 directed therapies, the prognosis of HER2 amplified breast cancers has improved meaningfully. Next to monoclonal anti-HER2 antibodies and tyrosine kinase inhibitors, the antibody-drug conjugate T-DM1 is a pillar of targeted treatment of advanced HER2-positive breast cancers. Currently, several HER2 directed antibody-drug conjugates are under clinical investigation for HER2 amplified but also HER2 expressing but not amplified breast tumors. In this article, we review the current preclinical and clinical evidence of the investigational drugs A166, ALT-P7, ARX788, DHES0815A, DS-8201a, RC48, SYD985, MEDI4276 and XMT-1522.

100 Deals associated with ALT-P7

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 2	KR	Alteogen, Inc.	11 Jan 2018
Stomach Cancer	Phase 1	CN	Shenyang Sunshine Pharmaceuticals Co., Ltd.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03281824 (ASCO2020)	Phase 1	Advanced HER2-Positive Breast Carcinoma	27	ALT-P7	gwuhrubwrx(bxmudxtixw) = alopecia occurred in 6 patients upmxusgdtx (mcjuvkdson ) View more	Positive	25 May 2020

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