Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33
NCT ID: NCT03544905
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
206 participants
INTERVENTIONAL
2018-07-05
2024-12-04
Brief Summary
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Detailed Description
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In the dose climbing part of phase Ia, the safety, tolerance and pharmacokinetics characteristics of CYH33 in patients with advanced solid tumors who failed to receive standard treatment, did not tolerate or did not have standard treatment at present will be observed to determine MTD; Before determining MTD, select safe and highly reliable and effective dose levels for simultaneous expansion. Phase Ia dose expansion includes patients with advanced solid tumors who have failed to undergo standard treatment, who are intolerant of PIK3CA gene mutation, or who do not have standard treatment at present, to further evaluate safety, tolerance and initial efficacy.
In Phase Ib, the safety and preliminary efficacy of CYH33 on patients with advanced breast cancer, ovarian cancer, endometrial cancer, cervical cancer, head and neck squamous cell carcinoma, esophageal and gastroesophageal junction squamous cell carcinoma, ovarian clear cell carcinoma and other solid tumors with PIK3CA gene mutation who have failed, are intolerant or do not have standard treatment at present will be evaluated.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose escalation study of CYH33
To determine the maximum tolerated dose (MTD) of CYH33
CYH33 for tablet
1mg; 5mg; 10mg; 20mg; 30mg; 50mg; 75mg; 100mg; 130mg; 160mg; 200mg; 240mgBID or QD(Decided by SMC accroding to the safty and PK data)
Interventions
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CYH33 for tablet
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
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Inclusion Criteria
1. Evidence of a personally signed informed consent document;
2. Male and/or female subjects above the ages of 18 years;
3. Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a;
4. Subject may provide Tumor tissue section(at least 8 pieces) if they agree;
5. ECOG performance score 0-1;
6. Life expectancy ≥ 12 weeks;
7. At least 1 measurable target lesion on the baseline scan as per RECIST 1.1
Exclusion Criteria
1. prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment;
2. Prior or concomitant other malignant tumor;
18 Years
ALL
No
Sponsors
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Haihe Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ruihua Xu, M.D
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Lu'an People's Hospital
Lu'an, Anhui, China
Lu'an Hospital of Traditional Chinese Medicine
Lu'an, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Xiang'an Hospital of Xiamen University
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences
Shenzhen, Guangdong, China
Liuzhou Workers Hospital
Liuzhou, Guangxi, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Anyang, Henan, China
Nanyang First People's Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Province Directly Affiliated Traditional Chinese Medicine Hospital
Zhuzhou, Hunan, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Dali University
Dali, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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CYH33-101
Identifier Type: -
Identifier Source: org_study_id
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