A Phase Ⅰ Clinical Study of GEN-725 Tablets in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Genuine Biotech Co., Ltd.
About this trial
A phase Ⅰ clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of GEN-725 tablets in patients with advanced solid tumors.
Eligibility criteria
Qualifiers
Understand and voluntarily sign the informed consent form (ICF).
Aged ≥ 18 years and ≤ 75 years, regardless of gender.
Presence of at least one measurable lesion (RECIST v1.1 criteria).
ECOG performance status score of 0 or 1.
Disqualifiers
Subjects with a history of allergic reactions to GEN-725 tablets or to active or inactive excipients of drugs with similar chemical structures or of the same class.
Subjects who have received anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug, or who plan to receive such vaccines during the study period.
Subjects who have received systemic therapy with corticosteroids (> 10 mg/day of dexamethasone or equivalent dose) or other immunosuppressive drugs within 4 weeks prior to the first dose of the investigational drug. However, topical applications (e.g., ointments, eye drops, inhalants, or nasal sprays) are permitted, provided the dosage does not exceed the recommended dose in the prescribing information and there are no signs of systemic exposure.
Subjects with a history of acute or chronic pancreatitis.
Trial design
Treatments tested in this trial
- GEN-725 tablets
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov