Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33
- Conditions
- Advanced Solid Tumors
- Interventions
- Drug: CYH33 for tablet
- Registration Number
- NCT03544905
- Lead Sponsor
- Haihe Biopharma Co., Ltd.
- 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.
- Detailed Description
This study includes Phase Ia and Phase Ib.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
-
main inclusion:
- 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
-
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose escalation study of CYH33 CYH33 for tablet To determine the maximum tolerated dose (MTD) of CYH33
- Primary Outcome Measures
Name Time Method MTD(Max tolerance does) 35 days To evaluate the MTD in patients with advanced solid tumor
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, 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
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
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, China
Obstetrics and Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, 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