Drugs / Dalpiciclib
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Dalpiciclib

Small molecule targets CDK4 via inhibition

Developed for
breast cancer · hormone receptor-positive breast cancer · female breast carcinoma · HER2 positive breast carcinoma · esophageal squamous cell carcinoma · head and neck squamous cell carcinoma · neoplasm · estrogen-receptor positive breast cancer
+22 more · Her2-receptor negative breast cancer · hepatocellular carcinoma · metastatic malignant neoplasm · non-small cell lung carcinoma · triple-negative breast carcinoma · breast carcinoma · breast carcinoma by gene expression profile · breast neoplasm · cancer · colorectal cancer · gastric cancer · luminal B breast carcinoma · melanoma · meningioma · metastatic malignant neoplasm in the brain · nasopharyngeal carcinoma · ovarian cancer · ovarian carcinoma · pancreatic ductal adenocarcinoma · prostate carcinoma · salivary gland carcinoma · sarcoma
Investigated by
Jiangsu HengRui Medicine Co., Ltd. · Fudan University · Tianjin Medical University Cancer Institute and Hospital · Sun Yat-sen University · Peking University Cancer Hospital & Institute · Henan Cancer Hospital
+59 more · Shengjing Hospital · Fujian Medical University Union Hospital · Hebei Medical University Fourth Hospital · Jiangsu Hengrui Pharmaceutical Co., Ltd. · Peking University · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Affiliated Hospital of Nantong University · Beijing 302 Hospital · Chongqing University Cancer Hospital · First Affiliated Hospital Xi'an Jiaotong University · First Hospital of China Medical University · Fujian Cancer Hospital · Harbin Medical University · Liaoning Cancer Hospital & Institute · Ningbo Medical Center Lihuili Hospital · Northern Jiangsu People's Hospital · Ruijin Hospital · Shandong Suncadia Medicine Co., Ltd. · Shanghai 6th People's Hospital · Shanghai First Maternity and Infant Hospital · The Affiliated Hospital of Qingdao University · West China Hospital · Zhejiang Cancer Hospital · Atridia Pty Ltd. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Capital Medical University · Chinese PLA General Hospital · Dongguan People's Hospital · Fengzhi Feng · Fifth Affiliated Hospital, Sun Yat-Sen University · First Affiliated Hospital of Zhejiang University · Fujian Medical University · GeneCast Biotechnology Co., Ltd. · Hongmei Zheng, PhD · Jiangmen Central Hospital · Jiangsu Famous Medical Technology Co., Ltd. · Jinming Yu · Liu Shu · Meizhou People's Hospital · Nanchang People's Hospital · Nanfang Hospital, Southern Medical University · Peking Union Medical College Hospital · Peking University People's Hospital · Risen (Suzhou) Pharma Tech Co., Ltd. · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shanghai Hengrui Pharmaceutical Co., Ltd. · Shuangyue Liu · Sixth Affiliated Hospital, Sun Yat-sen University · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sun Yat-sen University Cancer Center · Tang-Du Hospital · The First Affiliated Hospital of Xiamen University · The First Affiliated Hospital with Nanjing Medical University · The First Hospital of Jilin University · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Xinhong Wu, PhD · Yantai Yuhuangding Hospital · Zhongzheng Xiang · wanghaibo

Trials 109 · started per year

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2016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 121 trials
Phase 1 NCT07652762 Jun 2026 → Aug 2028 expected CDK4 linked melanoma, meningioma Capital Medical University Not yet recruiting No outcome recorded
Phase 1 NCT06225921 Dec 2023 → Jan 2025 esophageal squamous cell carcinoma West China Hospital Unknown No outcome recorded
Phase 1 NCT06109207 Oct 2023 → Oct 2024 overdue head and neck squamous cell carcinoma West China Hospital Recruiting No outcome recorded
Phase 1 NCT06099990 Oct 2023 → Dec 2028 expected prostate carcinoma Jiangsu HengRui Medicine Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT05628870 Feb 2023 → Jun 2025 overdue breast cancer Shandong Suncadia Medicine Co., Ltd. Recruiting No outcome recorded
Phase 1 NCT05515289 Dec 2022 → Aug 2023 breast cancer Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1 NCT05586841 Oct 2022 → Dec 2025 hormone receptor-positive breast cancer Beijing 302 Hospital Completed No outcome recorded
Phase 1 NCT04989829 Dec 2021 → Jan 2022 neoplasm Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT04993430 Oct 2021 → Dec 2026 expected breast carcinoma by gene expression profile Shanghai Hengrui Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 1 NCT05103826 Oct 2021 → Jun 2023 estrogen-receptor positive breast cancer Jiangsu HengRui Medicine Co., Ltd. Terminated No outcome recorded Stop: Business
Phase 1/211 trials
Phase 1/2 NCT07189884 Sep 2025 → Jun 2026 overdue breast cancer The First Affiliated Hospital of Xiamen University Not yet recruiting No outcome recorded
Phase 1/2 NCT06208410 Jan 2024 → Feb 2027 expected neoplasm Risen (Suzhou) Pharma Tech Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT06167694 Dec 2023 → Jun 2026 overdue breast carcinoma Shandong Suncadia Medicine Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT05792410 Apr 2023 → Feb 2024 Her2-receptor negative breast cancer Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT05574881 Sep 2022 → Jan 2025 breast cancer Fudan University Unknown No outcome recorded
Phase 1/2 NCT05176080 Dec 2021 → Jul 2024 breast cancer Henan Cancer Hospital Terminated Mixed
Phase 1/2 NCT04215003 Jan 2020 → Dec 2024 breast cancer Fudan University Unknown No outcome recorded
Phase 1/2 NCT03772353 May 2019 → Jun 2023 breast cancer Fudan University Unknown No outcome recorded
Phase 1/2 NCT03805399 Oct 2018 → Dec 2022 triple-negative breast carcinoma Fudan University Unknown No outcome recorded
Phase 1/2 NCT03601598 Jul 2018 → Jul 2019 hepatocellular carcinoma, non-small cell lung carcinoma Harbin Medical University Unknown No outcome recorded
Phase 262 trials · 1 met primary
Phase 2 NCT07815522 Oct 2026 → Oct 2028 expected salivary gland carcinoma Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Recruiting No outcome recorded
Phase 2 NCT07826052 Sep 2026 → Sep 2031 expected breast cancer Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT07610720 Jun 2026 → Nov 2028 expected HER2 positive breast carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT07539753 Jun 2026 → Aug 2029 expected Her2-receptor negative breast cancer, metastatic malignant neoplasm in the brain Nanfang Hospital, Southern Medical University Not yet recruiting No outcome recorded
Phase 2 NCT07618923 Jun 2026 → Jun 2028 expected hormone receptor-positive breast cancer Tang-Du Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07527806 May 2026 → May 2029 expected breast cancer Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT07581834 Jan 2026 → Dec 2031 expected hormone receptor-positive breast cancer Fujian Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT07307287 Dec 2025 → Dec 2027 expected HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07238881 Nov 2025 → Dec 2026 expected hepatocellular carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT06556862 Oct 2025 → Dec 2026 expected hormone receptor-positive breast cancer Beijing 302 Hospital Not yet recruiting No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT07653451 Jul 2026 → Dec 2027 expected esophageal squamous cell carcinoma Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2/3 NCT06009627 Apr 2023 → Mar 2025 breast cancer Tianjin Medical University Cancer Institute and Hospital Completed No outcome recorded
Phase 37 trials · 2 met primary
Phase 3 NCT07432178 Apr 2026 → Mar 2031 expected breast cancer Fudan University Recruiting No outcome recorded
Phase 3 NCT07005557 Jun 2025 → May 2030 expected breast cancer Fudan University Not yet recruiting No outcome recorded
Phase 3 NCT07615751 Feb 2025 → Dec 2028 expected breast cancer Fudan University Recruiting No outcome recorded
Phase 3 NCT05861830 May 2023 → Dec 2025 female breast carcinoma Peking Union Medical College Hospital Unknown No outcome recorded
Phase 3 NCT04842617 Apr 2021 → Oct 2026 expected hormone receptor-positive breast cancer Jiangsu HengRui Medicine Co., Ltd. Active not recruiting No outcome recorded
Phase 3 NCT03966898 Jul 2019 → Dec 2022 female breast carcinoma Jiangsu HengRui Medicine Co., Ltd. Unknown Met primary
Phase 3 NCT03927456 Jun 2019 → Dec 2021 breast cancer Jiangsu HengRui Medicine Co., Ltd. Unknown Met primary
Phase 41 trial
Phase 4 NCT06613373 Oct 2024 → Oct 2025 overdue breast cancer Jiangsu Famous Medical Technology Co., Ltd. Not yet recruiting No outcome recorded
Phase not applicable5 trials
— NCT07706933 Aug 2026 → Jun 2028 expected breast cancer Henan Cancer Hospital Not yet recruiting No outcome recorded
— NCT06810492 Apr → Dec 2025 overdue female breast carcinoma Hongmei Zheng, PhD Not yet recruiting No outcome recorded
— NCT06711094 Jan 2025 → Dec 2027 expected hormone receptor-positive breast cancer Fujian Medical University Not yet recruiting No outcome recorded
— NCT06605690 Oct 2024 → Aug 2025 overdue breast cancer Liu Shu Not yet recruiting No outcome recorded
— NCT05132790 Sep 2023 → Dec 2024 overdue breast cancer Shengjing Hospital Active not recruiting No outcome recorded
Comparator or background therapy13 trials
Phase 1 NCT05189717 Background Feb 2022 → Oct 2024 breast cancer Shandong Suncadia Medicine Co., Ltd. Unknown No outcome recorded
Phase 2 NCT07180160 Background Sep 2025 → Sep 2027 expected female breast carcinoma Wenjin Yin Recruiting No outcome recorded
Phase 2 NCT06149130 Background Jan 2024 → Nov 2025 overdue breast cancer Tongji Hospital Recruiting No outcome recorded
Phase 2 NCT06176534 Comparator Jan 2024 → Dec 2025 overdue Her2-receptor negative breast cancer, female breast carcinoma Henan Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT05949541 Background Jul 2023 → Jul 2026 overdue breast cancer Fudan University Recruiting No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 124 sources stand behind the page.

FieldValueCited text
Known as dalpiciclib “Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative...” PMID 37182538 ↗ May 2023
86

“Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone...” NCT06447623 ↗

“Dalpiciclib (SHR6390) is a novel inhibitor of cyclin-dependent kinase 4/6 which demonstrated promising anti-tumor potency in preclinical models.” PMID 33845905 ↗ Apr 2021

“Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial.” PMID 34737452 ↗ Nov 2021

“sequential Trastuzumab rezetecan followed by CDK4/6 inhibitors (Dalpiciclib, Abemaciclib, Ribociclib, Palbociclib) plus endocrine therapy” NCT07037199 ↗

“HRS-1358 or combination with Dalpiciclib Isethionate Tablets will be administered daily orally in continuous dosing over 28-day cycles.” NCT05628870 ↗

“The participants receive cetuximab in combination with Dalpiciclib until termination criteria are met.” NCT06935188 ↗

“Dalpiciclib: 125 mg, administered orally once daily at approximately the same time each day.” NCT07615751 ↗

“All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)” NCT07005557 ↗

“dalpiciclib:125mg once a day for 3 weeks and stop for 1 week. Q4W.” NCT07810088 ↗

“CDK4/6 inhibitors:dalpiciclib,palbociclib,abemaciclib,ribociclib” NCT07130643 ↗

Show 76 more sources

Known as Dalpiciclib Isethionate “The recommended dose of dalpiciclib isethionate is 150 mg once daily for 21 consecutive days, followed by a 7-day treatment break (3-on/1-off schedule), constituting a 28-day...” NCT07815522 ↗
1

“Dalpiciclib Isethionate tablets, 125mg, oral administration on days 1 to 21, followed by a 7-day drug holiday, every 4 weeks” NCT06684600 ↗

Known as Dalpiciclib Isethionate Tablets “Dalpiciclib Isethionate Tablets: 125 mg orally every 28 days as a treatment cycle, with continuous medication for the first 3 weeks (Day 1 to Day 21), and rest (no medication)...” NCT07189884 ↗
Known as SHR-6390 “Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone...” NCT06447623 ↗
39

“Drug Dalpiciclib 100mg/125mg/150mg PO qd, administered only from day1 to day 21 every cycle until disease progression, unacceptable toxicity or death. 28 days as a treatment...” NCT05952128 ↗

“Pyrotinib Maleate, Trastuzumab, SHR6390(Dalpiciclib) and Letrozole in Combination for Neoadjuvant Treatment of Stage II-III TPBC” NCT05228951 ↗

“SHR6390(CDK4/6 inhibitor)125 mg qd(three week on one week off)” NCT04215003 ↗

“combined with CDK4/6 inhibitor SHR6390 150mg qd” NCT03805399 ↗

NCT02684266 ↗

NCT04355858 ↗

NCT03993964 ↗

NCT03966898 ↗

NCT04616742 ↗

NCT05205200 ↗

Show 29 more sources

Action Inhibit “SHR6390 is a small molecular,oral potent, selective CDK4/6 inhibitor.” NCT02671513 ↗
Modality Small molecule “SHR6390 is a small molecular,oral potent, selective CDK4/6 inhibitor.” NCT02671513 ↗
Route Oral “given orally” NCT02671513 ↗
Target CDK4 “SHR6390 is a small molecular, oral potent, selective CDK4/6 inhibitor.” NCT02684266 ↗