Advanced Solid TumorsPhase 1NCT03544905
Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33
A Phase 1 study testing CYH33 for tablet in people with Advanced Solid Tumors, run by Haihe Biopharma Co., Ltd. at 30 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- CYH33 for tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 30 sitesChina
- Study dates
- 5 Jul 2018to 4 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites
Anyang Cancer Hospital
Anyang, Henan, 455000
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Hunan Cancer Hospital
Changsha, Hunan, 410013
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
The First Affiliated Hospital of Dali University
Dali, Yunnan, 671000
Dongguan People's Hospital
Dongguan, Guangdong, 523000
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510220
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Anhui Provincial Hospital
Hefei, Anhui, 230001
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Liuzhou Workers Hospital
Liuzhou, Guangxi, 545005
Lu'an People's Hospital
Lu'an, Anhui, 237005
Lu'an Hospital of Traditional Chinese Medicine
Lu'an, Anhui, 237006
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Nanyang First People's Hospital
Nanyang, Henan, 473000
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200090
Yuebei People's Hospital
Shaoguan, Guangdong, 512026
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences
Shenzhen, Guangdong, 518116
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Xiang'an Hospital of Xiamen University
Xiamen, Fujian, 361101
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Hunan Province Directly Affiliated Traditional Chinese Medicine Hospital
Zhuzhou, Hunan, 412002
About this study
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.
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- CYH33 for tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYH33 for tabletDrug
1mg; 5mg; 10mg; 20mg; 30mg; 50mg; 75mg; 100mg; 130mg; 160mg; 200mg; 240mgBID or QD(Decided by SMC accroding to the safty and PK data)
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation study of CYH33 | Experimental | To determine the maximum tolerated dose (MTD) of CYH33 Receives: Drug: CYH33 for tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD(Max tolerance does)
To evaluate the MTD in patients with advanced solid tumor
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start5 Jul 2018
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haihe Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, M.D, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544905
- Sponsor's protocol ID
- CYH33-101
- Status last verified
- Apr 2025
- First submitted
- 22 May 2018
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03544905
- Acronym / sponsor ID
- CYH33-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Haihe Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation study of CYH33 | Experimental | Drug: CYH33 for tabletTo determine the maximum tolerated dose (MTD) of CYH33 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- main inclusion:
Key exclusion criteria (3 listed)
- main criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYH33 for tablet1mg; 5mg; 10mg; 20mg; 30mg; 50mg; 75mg; 100mg; 130mg; 160mg; 200mg; 240mgBID or QD(Decided by SMC accroding to the safty and PK data) | Drug | Dose escalation study of CYH33 |
Primary outcome
MTD(Max tolerance does)
Time frame: 35 days
To evaluate the MTD in patients with advanced solid tumor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruihua Xu, M.D principal investigator
Sun Yat-Sen University Cancer Center
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CYH33 for tablet in people with Advanced Solid Tumors, run by Haihe Biopharma Co., Ltd. at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD(Max tolerance does) (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.