The study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD).

The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.Single drug dose expansion was performed in different tumors, such as :Non-small cell lung cancer, small cell lung cancer, Esophageal squamous cell carcinoma, Alveolar soft part sarcoma

The dose groups of ZG005 for dose escalations are set as 0.3 mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, and 20mg/kg, intravenous infusion, once every 3 weeks.

ZG005 Powder for Injection

Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy, intravenous infusion, once every 3 weeks.

Yongsheng Chu

Ying Cheng

Jason Wu

This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose.

A Study of ZG005 in Patients With Advanced Solid Tumors

A Phase 1/2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors

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.

Number of participants with adverse events that are related to treatment

Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

During the dose escalation stage, if 2 of up to 6 subjects in the first dose groups experienced DLT, then the dose level will be considered to be an intolerable dose or DLT dose level, and the previous lower dose will be considered to be the MTD.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Neoplasms

All Conditions

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Carboplatin

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen

Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen

ZG005 for dose escalations are set as 10 mg/kg, 15 mg/kg and other doses after discussion, intravenous infusion(IV), once every 3 weeks (Q3W). ZG005 for dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.

Hanmei Lou

This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.

Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical Carcinoma

A Phase I/II Study to Evaluate Safety and Pharmacokinetics and Initial Efficacy of ZG005 in Combination With Paclitaxel Plus Cisplatin/Carboplatin ± Bevacizumab in Patients With Advanced Cervical Carcinoma

ORR was defined as the percentage of the participants in the analysis population who have a Complete Response or a Partial Response. The ORR per RECIST 1.1 as assessed by Investigator is presented.

Digestive System Diseases

Carcinoma, Hepatocellular

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.

Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.

ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).

Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).

Donafenib Tosilate Tablets

Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).

Xiaoli Chai

This is a randomized, open-label study to evaluate the safety and efficacy of ZG005 in combination with Donafenib or Bevacizumab in patients with advanced hepatocellular carcinoma.

A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma

A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib Tosilate Tablets or Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

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 from first dose of the investigational drug to PD or death from any cause.

Changsha Taihe Hospital

Anti-Obesity Agents

Vasoconstrictor Agents

Respiratory System Agents

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

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.

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.

intravenous infusion(IV), once every 3 weeks

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

Cheng Wei

Bo Zhu

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.

A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor

A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor

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 from the first evaluated CR or PR until PD or death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of ZG005 in Patients With Advanced Solid Tumors	NCT06233292	Solid Tumors	ZG005 Powder fo... ZG005 Powder fo...	18 Years - 70 Years	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical Carcinoma	NCT06241235	Cervical Carcin...	ZG005 Powder fo... Paclitaxel Bevacizumab Cisplatin Carboplatin	18 Years - 70 Years	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma	NCT06233994	Advanced Hepato...	ZG005 Powder fo... Donafenib Tosil... Bevacizumab	18 Years -	Changsha Taihe Hospital
A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor	NCT06239298	Solid Tumor	ZG005 Powder fo... Donafenib Tosil...	18 Years - 70 Years	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical Carcinoma	NCT06241235	Cervical Carcin...	ZG005 Powder fo... Paclitaxel Bevacizumab Cisplatin Carboplatin	18 Years - 70 Years	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
A Study of ZG005 in Patients With Advanced Solid Tumors	NCT06233292	Solid Tumors	ZG005 Powder fo... ZG005 Powder fo...	18 Years - 70 Years	Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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