Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33
A Multi-center, Open-label, Single Arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.
1 other identifier
interventional
206
1 country
30
Brief Summary
This study is a Multi-center, Open-label, single arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety , Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2018
Longer than P75 for phase_1
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedStudy Start
First participant enrolled
July 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2024
CompletedApril 22, 2025
April 1, 2025
6.4 years
May 22, 2018
April 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
MTD(Max tolerance does)
To evaluate the MTD in patients with advanced solid tumor
35 days
Study Arms (1)
Dose escalation study of CYH33
EXPERIMENTALTo determine the maximum tolerated dose (MTD) of CYH33
Interventions
1mg; 5mg; 10mg; 20mg; 30mg; 50mg; 75mg; 100mg; 130mg; 160mg; 200mg; 240mgBID or QD(Decided by SMC accroding to the safty and PK data)
Eligibility Criteria
You may qualify if:
- Evidence of a personally signed informed consent document;
- Male and/or female subjects above the ages of 18 years;
- Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a;
- Subject may provide Tumor tissue section(at least 8 pieces) if they agree;
- ECOG performance score 0-1;
- Life expectancy ≥ 12 weeks;
- At least 1 measurable target lesion on the baseline scan as per RECIST 1.1
You may not qualify if:
- main criteria:
- prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment;
- Prior or concomitant other malignant tumor;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Lu'an People's Hospital
Lu'an, Anhui, 237005, China
Lu'an Hospital of Traditional Chinese Medicine
Lu'an, Anhui, 237006, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Xiang'an Hospital of Xiamen University
Xiamen, Fujian, 361101, China
Dongguan People's Hospital
Dongguan, Guangdong, 523000, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510220, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, 512026, China
Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences
Shenzhen, Guangdong, 518116, China
Liuzhou Workers Hospital
Liuchow, Guangxi, 545005, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Anyang Cancer Hospital
Anyang, Henan, 455000, China
Nanyang First People's Hospital
Nanyang, Henan, 473000, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Hunan Province Directly Affiliated Traditional Chinese Medicine Hospital
Zhuzhou, Hunan, 412002, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200090, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital of Dali University
Dali, Yunnan, 671000, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruihua Xu, M.D
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 4, 2018
Study Start
July 5, 2018
Primary Completion
December 4, 2024
Study Completion
December 4, 2024
Last Updated
April 22, 2025
Record last verified: 2025-04