Advanced Tumors
Conditions
Keywords
GW01-200, Phase I trial, Advanced tumors
Brief 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.
Interventions
DRUGGW01-200
GW01-200 tablets will be administered orally.
Sponsors
Groovy Medicine (Hangzhou) Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) and serious AEs (SAEs) | 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 | 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. | 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 | Up to approximately 2 years | The RP2D of GW01-200 tablets will be determined based on the data obtained from Parts C and D. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration (Cmax) | Up to approximately 2 years | To characterise the pharmacokinetics (PK) of GW01-200 when given orally. |
| Area under the concentration-time curve (AUC) | Up to approximately 2 years | To characterise the pharmacokinetics (PK) of GW01-200 when given orally. |
| Time to maximum concentration (Tmax) | Up to approximately 2 years | To characterise the pharmacokinetics (PK) of GW01-200 when given orally. |
| Elimination half-life (t1/2) | Up to approximately 2 years | To characterise the pharmacokinetics (PK) of GW01-200 when given orally |
| Parts A and B: The preliminary efficacy of GW01-200 tablets in participants with advanced tumors | Up to approximately 2 years | ORR assessed by investigator. |
| Duration of response (DoR) | Up to approximately 2 years | To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors. |
| Disease control rate (DCR) | Up to approximately 2 years | To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors. |
| Progression-free survival (PFS) | Up to approximately 2 years | To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors. |
Countries
China
Contacts
CONTACTYongchao Li
Outcome results
None listed