A Phase I Trial of GW01-200 Tablets in Subjects With Advanced Tumors (GW01-200-01)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Tumors
• Intervention / Treatment: Drug: GW01-200

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yongchao Li; Phone Number: 86-13336882732; Email: liyongchao@groovymedicine.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Peking University Cancer Hospital
      • Contact: Zhi-Hao Lu, M.D.; Phone Number: 86-13810549767; Email: 13810549767@126.com
      • Principal Investigator: Zhi-Hao Lu, M.D.
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
      • Contact: Zheng-Bo Song, M.D.; Phone Number: 86-13857153345; Email: songzb@zjcc.org.cn
      • Principal Investigator: Zheng-Bo Song, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ia-Part A; Participants with advanced solid tumors will receive GW01-200 tablets orally at ascending dose levels.	Drug: GW01-200; GW01-200 tablets will be administered orally.
Experimental: Ia-Part B; Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets orally at ascending dose levels.	Drug: GW01-200; GW01-200 tablets will be administered orally.
Experimental: Ib-Part C; Participants with advanced solid tumors will receive GW01-200 tablets at the specified dose.	Drug: GW01-200; GW01-200 tablets will be administered orally.
Experimental: Ib-Part D; Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets at the specified dose.	Drug: GW01-200; GW01-200 tablets will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs) and serious AEs (SAEs)	To assess the safety and tolerability of GW01-200 tablets.	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)	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.	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.	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration (Cmax)	To characterise the pharmacokinetics (PK) of GW01-200 when given orally.	Up to approximately 2 years
Area under the concentration-time curve (AUC)	To characterise the pharmacokinetics (PK) of GW01-200 when given orally.	Up to approximately 2 years
Time to maximum concentration (Tmax)	To characterise the pharmacokinetics (PK) of GW01-200 when given orally.	Up to approximately 2 years
Elimination half-life (t1/2)	To characterise the pharmacokinetics (PK) of GW01-200 when given orally	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.	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.	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.	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.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Groovy Medicine (Hangzhou) Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Advanced tumors; Phase I trial; GW01-200
• Other Study ID Numbers: GW01-200-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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