Advanced Solid Tumor
Conditions
Brief summary
This is a multicenter, open-label phase I/II study for participants with advanced solid tumors who have failed prior immune checkpoint inhibitor therapies.
Interventions
DRUGZG005
ZG005 20mg/kg; once every 3 weeks；IV infusion
DRUGGecacitinib
Gecacitinib for dose escalations are set as 100mg Bid po. Gecacitinib for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Fully understand the study and voluntarily sign the informed consent form. * Male or female 18-75 years of age. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * PART 1: Histologically confirmed unresectable locally advanced, recurrent, or metastatic solid tumors.PART 2 Cohort A: Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Cohort B: Histologically confirmed unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Cohort C: Histologically confirmed unresectable locally advanced, recurrent, or metastatic other solid tumors. * Life expectancy ≥ 3 months.
Exclusion criteria
* participants were deemed unsuitable for participating in the study by the investigator for any reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity (DLT) | During the first 28 days |
| Objective Response Rate (ORR) | Up to 2 years |
| Adverse events (AEs) | Up to 2 years |
Countries
China
Contacts
Primary ContactBo Liu
Outcome results
None listed