Clinical trial NCT03544905: Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Haihe Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-04
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* main inclusion:

  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:

* main 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;

Primary outcomes:
measure: MTD(Max tolerance does)
timeFrame: 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Lu'an
country: China
facility: Lu'an People's Hospital
state: Anhui
city: Lu'an
country: China
facility: Lu'an Hospital of Traditional Chinese Medicine
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Xiamen
country: China
facility: Xiang'an Hospital of Xiamen University
state: Fujian
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: GuangZhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Shaoguan
country: China
facility: Yuebei People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Workers Hospital
state: Guangxi
city: Nanning
country: China
facility: Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Zhuzhou
country: China
facility: Hunan Province Directly Affiliated Traditional Chinese Medicine Hospital
state: Hunan
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Dali
country: China
facility: The First Affiliated Hospital of Dali University
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Sun Yat-sen University
name: Ruihua Xu, M.D
role: PRINCIPAL_INVESTIGATOR
References: