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Recruiting Phase 1 NCT05877664

Study of ZG0895.HCl in Patients With Advanced Solid Tumors

Trial Parameters

Condition Advanced Solid Tumor
Sponsor Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-08-08
Completion 2026-06
Interventions
ZG0895 Hydrochloride for Injection

Brief Summary

The primary objective of this study is to assess the tolerability and safety of ZG0895.HCl, and to assess the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of ZG0895.HCl.

Eligibility Criteria

Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form(ICF). * Age ≥ 18 and ≤ 75 years old at the time of signing the ICF, either male or female; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Life expectancy ≥ 3 months. * All adverse events from prior treatment have either returned to baseline or CTCAE 5.0 ≤ Grade 1(except for AEs not constituting a safety risk in the opinions of the investigators, e.g. alopecia, hypothyroidism which can be treated with a hormone replacement, etc). * Both male and female participants (unless postmenopausal, surgical sterilization) and partners must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug. * For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions. Part 1: * Must have at least 1 measurable lesion per Resp

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