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CompletedNCT03544905Updated Apr 22, 2025

Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33

A Phase 1 interventional study of CYH33 for tablet in Advanced Solid Tumors, sponsored by Haihe Biopharma Co., Ltd.. Completed at 30 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-22.

Sponsored by Haihe Biopharma Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
206
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Advanced Solid Tumors
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
206 participants (actual)

Study arms

  • Experimental
    Dose escalation study of CYH33

    To determine the maximum tolerated dose (MTD) of CYH33

    Drug: CYH33 for tablet

Interventions

  • DrugCYH33 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)

05

What researchers measure

Primary outcomes

  1. MTD(Max tolerance does)

    To evaluate the MTD in patients with advanced solid tumor

    Time frame: 35 days

06

Study locations

30 sites
  • 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 100142, China
  • Chongqing Cancer Hospital
    Chongqing, Chongqing 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
    Liuzhou, 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 200032, China
  • Obstetrics and Gynecology Hospital of Fudan University
    Shanghai, Shanghai 200090, China
  • Tianjin Medical University Cancer Institute & Hospital
    Tianjin, Tianjin 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
07

Registry details

Key details

Study ID
NCT03544905
Lead sponsor
Haihe Biopharma Co., Ltd.
Responsible party
Sponsor
First posted
Jun 4, 2018
Start date
Jul 5, 2018
Primary completion
Dec 4, 2024
Completion
Dec 4, 2024
Last update
Apr 22, 2025

Study contacts

Ruihua Xu, M.D
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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