A Phase 1/2 interventional study of ZG005 Powder for Injection and Donafenib Tosilate Tablets in Solid Tumor, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 1/2, Interventional, and Treatment
This is a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.
Suzhou Zelgen Biopharmaceuticals Co.,Ltd is the lead sponsor of 83 studies on the registry; 30 are open to participants now.
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The first stage is a dose-exploration study of ZG005 combined with Donafenib to evaluate the safety and tolerability of different dose combinations in patients with advanced solid tumors who have failed standard therapy.
Drug: ZG005 Powder for Injection · Drug: Donafenib Tosilate Tablets
The second stage is a dose-expansion study to further evaluate the safety and initial efficacy of the combination regimen in hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and other potentially beneficial solid tumors.
Drug: ZG005 Powder for Injection · Drug: Donafenib Tosilate Tablets
intravenous infusion(IV), once every 3 weeks
Also known as: ZG005
The dose groups of Donafenib for dose-exploration stage are set as 0.2g BID, 0.1g BID, and 0.1g QD, oral administration.The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage
Also known as: Donafenib
Objective Response Rate (ORR)
The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.
Time frame: Up to 2 years
Dose Limiting Toxicity (DLT)
A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause
Time frame: Up to 2 years
Duration of response (DOR)
Time from the first evaluated CR or PR until PD or death from any cause
Time frame: Up to 2 years
Plan to share: No
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This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Nilvanstomig · Donafenib tosylate
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