A Phase I Trial of GW01-200 Tablets in Subjects With Advanced Tumors
ConditionAdvanced Tumors
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
GW01-200
DrugGW01-200 tablets will be administered orally.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Ia-Part AExperimental treatment 1 intervention
Group B: Ia-Part BExperimental treatment 1 intervention
Group C: Ib-Part CExperimental treatment 1 intervention
Group D: Ib-Part DExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with adverse events (AEs) and serious AEs (SAEs)
To assess the safety and tolerability of GW01-200 tablets.
Time frame
Up to approximately 2 years2
Parts A and B: The recommended dose(s) for expansion (RDEs) of GW01-200 tablets
Number of participants with dose-limiting toxicities (DLTs)
Time frame
At the end of Cycle 1 (each cycle is 28 days)3
Parts C and D: The preliminary efficacy of GW01-200 tablets at the RDEs dose.
Objective response rate (ORR) assessed by investigator.
Time frame
Up to approximately 2 years4
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.
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Maximum concentration (Cmax)
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Time frame
Up to approximately 2 years2
Area under the concentration-time curve (AUC)
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Time frame
Up to approximately 2 years3
Time to maximum concentration (Tmax)
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Time frame
Up to approximately 2 years4
Elimination half-life (t1/2)
To characterise the pharmacokinetics (PK) of GW01-200 when given orally
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov