SMP-656 for HER2-Positive Advanced Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor antibody-drug conjugate (ADC) treatment. It will also evaluate the safety of SMP-656 and identify the optimal dose for future trials. The main questions it aims to answer are: What is the objective tumor response rate (DOR, PFS, DCR, OS) of two different dose regimens of intravenous SMP-656? What are the side effects and safety risks of these two SMP-656 dose regimens? Which dose level achieves the best balance of anti-cancer activity and tolerability? This is a randomized, open-label, dose-optimization Phase II clinical trial. Participants will be randomly assigned 1:1 to receive one of two fixed doses of SMP-656 given intravenously once every 3 weeks. Participants will: Complete screening tests within 28 days before the first SMP-656 infusion to confirm eligibility Receive study treatment every 3 weeks until cancer progression, intolerable side effects, withdrawal, or other stopping criteria Have regular tumor imaging scans, physical exams, vital sign checks, and blood tests to monitor tumor response and safety Attend a safety follow-up visit 30 days after the last dose of SMP-656 Complete longer-term survival follow-up after the 30-day safety check Provide optional blood and tumor tissue samples for additional research studies
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku co najmniej 18 lat
- •Potwierdzona diagnoza raka piersi HER2-dodatniego, który nie można operować lub rozprzestrzenił się na inne organy
- •Wcześniejsze leczenie jednym rodzajem terapii skierowanej na HER2 (np. DS-8201) oraz pogorszenie się nowotworu po tej terapii
- •Obecny mierzalny guz widoczny w badaniach obrazowych
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (ECOG 0-1)
- •Spodziewana długość życia co najmniej 3 miesiące
- •Prawidłowe wyniki badań krwi oraz funkcji wątroby i nerek w ciągu 7 dni przed pierwszą dawką
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (15)
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
Beijing Cancer Hospital
Beijing, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Henan Provincial People's Hospital
Zhengzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Zhongnan Hospital of Wuhan University
Wuhan, China
The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, China
Zhongda Hospital, Southeast University
Nanjing, China
Liaoning Cancer Hospital & Institute
Shenyang, China
Shandong Cancer Hospital and Institute
Jinan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, China
Sichuan Cancer Hospital & Institute
Chengdu, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
Trial contact
Xiaoxia Li
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/16/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.