A Phase I Trial of GW01-200 Tablets in Subjects With Advanced Tumors
ConditionAdvanced Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroovy Medicine (Hangzhou) Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- GW01-200
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov