Advanced TumorsPhase 1GW01-200-01NCT07629258

A Phase I Trial of GW01-200 Tablets in Subjects With Advanced Tumors

A Phase 1 study testing GW01-200 in people with Advanced Tumors, run by Groovy Medicine (Hangzhou) Ltd. at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

A phase 1, open-label, first-in-human study mainly aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GW01-200 tablets in participants with advanced tumors, including solid tumors and hematological malignancies. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Tumors
What is being tested?: GW01-200
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 3 sitesChina
Study dates: 17 Jul 2026to Jun 2029
Phase: Phase 1
Are there results?: Not yet: the study is under way

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

Documented locally advanced or metastatic solid tumors or advanced hematological malignancies, with disease progression after standard treatment, or intolerant to standard treatment, or no standard treatment is available.
Have at least one measurable target lesion.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Minimum life expectancy ≥ 3 months.
Adequate organ and marrow function.

Who cannot join

Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s).
History of other primary malignancies, except for those who have been curatively treated and have no known active disease within 5 years prior to the first dose with a very low potential for recurrence, or adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid cancer with no evidence of disease.
Presence of primary central nervous system (CNS) tumors or symptomatic brain metastases; prior or current leptomeningeal disease or spinal cord compression.
Radiographic evidence of tumor invasion into major blood vessels (tumor completely approaching, surrounding, or invading the lumen of major blood vessels such as the pulmonary artery or superior vena cava) or evidence of tumor thrombus.
Received systemic anti-tumor therapy within 28 days prior to the first dose, including chemotherapy, targeted therapy, anti-angiogenic drugs, biological therapy, immunotherapy, radiotherapy, etc., or received traditional Chinese medicine or herbal medicines with clear anti-tumor effects within 1 week prior to the first dose.
Treatment with medications that may affect the metabolism of the investigational drug within 14 days prior to the first dose, such as strong CYP3A inhibitors, strong CYP3A inducers, or P-gp inhibitors.

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Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of the investigational drug.
Known to have active infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis.
Known history of infection with human immunodeficiency virus (HIV).
Active gastrointestinal disease or other condition that will interfere significantly with the swallowing, absorption, distribution, metabolism, or excretion of oral therapy.
For female subjects: currently pregnant or lactating.
Presence of clinically significant severe ophthalmic examination abnormalities at screening, such as retinitis pigmentosa, maculopathy, active ocular infection, etc., or known history of retinal or optic nerve disorders, such as retinitis pigmentosa, maculopathy, glaucoma, optic neuritis, etc.
Participants with a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or a history of melena or hematemesis within 2 months before dosing, or those who may experience visceral hemorrhage as determined by the investigator.
Clinically symptomatic moderate to severe ascites or pleural effusion, or presence of uncontrolled or moderate to severe pericardial effusion.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yongchao Li contact

86-13336882732

liyongchao@groovymedicine.com

China3 sites, 3 recruiting

Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Zhi-Hao Lu, M.D., 86-13810549767, 13810549767@126.com
Zhi-Hao Lu, M.D.
Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zheng-Bo Song, M.D., 86-13857153345, songzb@zjcc.org.cn
Zheng-Bo Song, M.D.
Recruiting
Hebei Cancer Hospital of Chinese Academy of Medical Sciences
Langfang, Heibei, 065000
Yong-Kun Sun, M.D., 86-131 4127 6041, hsunyk@cicams.ac.cn
Recruiting

Other trials in China

About this study

Official title: A First-in-Human Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GW01-200 Tablets in Subjects With Advanced Tumors

Conditions: Advanced Tumors
Being tested: GW01-200
Keywords: GW01-200, Phase I trial, Advanced tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GW01-200Drug
GW01-200 tablets will be administered orally.

Study groups in NCT07629258
Study group	Role	What they receive
Ia-Part A	Experimental	Participants with advanced solid tumors will receive GW01-200 tablets orally at ascending dose levels. Receives: Drug: GW01-200
Ia-Part B	Experimental	Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets orally at ascending dose levels. Receives: Drug: GW01-200
Ib-Part C	Experimental	Participants with advanced solid tumors will receive GW01-200 tablets at the specified dose. Receives: Drug: GW01-200
Ib-Part D	Experimental	Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets at the specified dose. Receives: Drug: GW01-200

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events (AEs) and serious AEs (SAEs)
To assess the safety and tolerability of GW01-200 tablets.
Measured: Up to approximately 2 years
Parts A and B: The recommended dose(s) for expansion (RDEs) of GW01-200 tablets
Number of participants with dose-limiting toxicities (DLTs)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Parts C and D: The preliminary efficacy of GW01-200 tablets at the RDEs dose.
Objective response rate (ORR) assessed by investigator.
Measured: Up to approximately 2 years
Parts C and D: The recommended Phase II Dose (RP2D) of GW01-200 tablets
The RP2D of GW01-200 tablets will be determined based on the data obtained from Parts C and D.
Measured: Up to approximately 2 years

Secondary outcomes (8)

Maximum concentration (Cmax)
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Measured: Up to approximately 2 years
Area under the concentration-time curve (AUC)
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Measured: Up to approximately 2 years
Time to maximum concentration (Tmax)
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Measured: Up to approximately 2 years
Elimination half-life (t1/2)
To characterise the pharmacokinetics (PK) of GW01-200 when given orally
Measured: Up to approximately 2 years
Parts A and B: The preliminary efficacy of GW01-200 tablets in participants with advanced tumors
ORR assessed by investigator.
Measured: Up to approximately 2 years
Duration of response (DoR)
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
Measured: Up to approximately 2 years
Disease control rate (DCR)
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
Measured: Up to approximately 2 years
Progression-free survival (PFS)
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 2026Jun 2029

First posted5 Jun 2026
Study start17 Jul 2026
Primary completionJan 2029 (estimated)
Study completionJun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07629258
Sponsor's protocol ID: GW01-200-01
Acronym: GW01-200-01
Status last verified: Aug 2026
First submitted: 27 May 2026
Last updated: 14 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First-in-Human Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GW01-200 Tablets in Subjects With Advanced Tumors
ClinicalTrials.gov ID: NCT07629258
Acronym / sponsor ID: GW01-200-01 / GW01-200-01
Conditions: Advanced Tumors
Keywords: GW01-200, Phase I trial, Advanced tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Groovy Medicine (Hangzhou) Ltd.Industry (pharma, biotech, devices)
Study start: 17 Jul 2026 (actual)
Primary completion: Jan 2029 (estimated)
Study completion: Jun 2029 (estimated)
First posted: 5 Jun 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Ia-Part A	Experimental	Drug: GW01-200Participants with advanced solid tumors will receive GW01-200 tablets orally at ascending dose levels.
Ia-Part B	Experimental	Drug: GW01-200Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets orally at ascending dose levels.
Ib-Part C	Experimental	Drug: GW01-200Participants with advanced solid tumors will receive GW01-200 tablets at the specified dose.
Ib-Part D	Experimental	Drug: GW01-200Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets at the specified dose.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Documented locally advanced or metastatic solid tumors or advanced hematological malignancies, with disease progression after standard treatment, or intolerant to standard treatment, or no standard treatment is available.
Have at least one measurable target lesion.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Minimum life expectancy ≥ 3 months.
Adequate organ and marrow function.

Key exclusion criteria (14 listed)

Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s).
History of other primary malignancies, except for those who have been curatively treated and have no known active disease within 5 years prior to the first dose with a very low potential for recurrence, or adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid cancer with no evidence of disease.
Presence of primary central nervous system (CNS) tumors or symptomatic brain metastases; prior or current leptomeningeal disease or spinal cord compression.
Radiographic evidence of tumor invasion into major blood vessels (tumor completely approaching, surrounding, or invading the lumen of major blood vessels such as the pulmonary artery or superior vena cava) or evidence of tumor thrombus.
Received systemic anti-tumor therapy within 28 days prior to the first dose, including chemotherapy, targeted therapy, anti-angiogenic drugs, biological therapy, immunotherapy, radiotherapy, etc., or received traditional Chinese medicine or herbal medicines with clear anti-tumor effects within 1 week prior to the first dose.

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
GW01-200GW01-200 tablets will be administered orally.	Drug	Ia-Part A, Ia-Part B, Ib-Part C, Ib-Part D

Primary outcome

Number of participants with adverse events (AEs) and serious AEs (SAEs)
Time frame: Up to approximately 2 years
To assess the safety and tolerability of GW01-200 tablets.
Parts A and B: The recommended dose(s) for expansion (RDEs) of GW01-200 tablets
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Number of participants with dose-limiting toxicities (DLTs)
Parts C and D: The preliminary efficacy of GW01-200 tablets at the RDEs dose.
Time frame: Up to approximately 2 years
Objective response rate (ORR) assessed by investigator.
Parts C and D: The recommended Phase II Dose (RP2D) of GW01-200 tablets
Time frame: Up to approximately 2 years
The RP2D of GW01-200 tablets will be determined based on the data obtained from Parts C and D.

8 secondary outcomes

Maximum concentration (Cmax)
Time frame: Up to approximately 2 years
Area under the concentration-time curve (AUC)
Time frame: Up to approximately 2 years
Time to maximum concentration (Tmax)
Time frame: Up to approximately 2 years
Elimination half-life (t1/2)
Time frame: Up to approximately 2 years
Parts A and B: The preliminary efficacy of GW01-200 tablets in participants with advanced tumors
Time frame: Up to approximately 2 years
Duration of response (DoR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
Individual participant dataSharing planned: No

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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.

Yongchao Li contact

86-13336882732

liyongchao@groovymedicine.com

3 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 GW01-200 in people with Advanced Tumors, run by Groovy Medicine (Hangzhou) Ltd. at 3 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yongchao Li (86-13336882732, liyongchao@groovymedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) and serious AEs (SAEs) (time frame: Up to approximately 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07629258.

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 14 Aug 2026.