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.

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: CYH33 for tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
    • Lu'an, Anhui, China, 237005
      • Lu'an People's Hospital
    • Lu'an, Anhui, China, 237006
      • Lu'an Hospital of Traditional Chinese Medicine
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Chongqing Cancer Hospital
  • Fujian
    • Xiamen, Fujian, China, 361101
      • Xiang'an Hospital of Xiamen University
  • Guangdong
    • Dongguan, Guangdong, China, 523000
      • Dongguan People's Hospital
    • GuangZhou, Guangdong, China, 510220
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
    • Shaoguan, Guangdong, China, 512026
      • Yuebei People's Hospital
    • Shenzhen, Guangdong, China, 518116
      • Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences
  • Guangxi
    • Liuzhou, Guangxi, China, 545005
      • Liuzhou Workers Hospital
    • Nanning, Guangxi, China, 530021
      • Affiliated Tumor Hospital of Guangxi Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Anyang, Henan, China, 455000
      • Anyang Cancer Hospital
    • Nanyang, Henan, China, 473000
      • The First Affiliated Hospital of Nanyang Medical College
    • Nanyang, Henan, China, 473000
      • Nanyang First People's Hospital
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital of Wuhan University
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
    • Zhuzhou, Hunan, China, 412002
      • Hunan Province Directly Affiliated Traditional Chinese Medicine Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University
    • Shanghai, Shanghai, China, 200090
      • Obstetrics and Gynecology Hospital of Fudan University
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute & Hospital
  • Yunnan
    • Dali, Yunnan, China, 671000
      • The First Affiliated Hospital of Dali University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation study of CYH33; To determine the maximum tolerated dose (MTD) of CYH33	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTD(Max tolerance does)	To evaluate the MTD in patients with advanced solid tumor	35 days

Collaborators and Investigators

• Sponsor: Haihe Biopharma Co., Ltd.
• Investigators: Principal Investigator: Ruihua Xu, M.D, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2018
• Primary Completion (Actual): December 4, 2024
• Study Completion (Actual): December 4, 2024

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Esophageal Neoplasms
• Other Study ID Numbers: CYH33-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No