> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-zg005-in-patients-with-advanced-solid-tumors-363ac268-b48a-42f4-858d-c97792a20df9 > Record changed: 2026-10-13 # A Study of ZG005 in Patients With Advanced Solid Tumors NCT06233292 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) Participants 484 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) Lead sponsor Suzhou Zelgen Biopharmaceuticals Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) Start date 2022-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Short title** A Study of ZG005 in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Official title** A Phase 1/2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Dates **Completion date** 2026-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **First posted** 2024-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Registry last updated** 2024-06-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Primary completion date** 2026-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Start date** 2022-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Size and sites **Participants** 484 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Planned participants** 484 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Lead sponsor** Suzhou Zelgen Biopharmaceuticals Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Identifiers **Registry ID** NCT06233292 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **ClinicalTrials.gov ID** NCT06233292 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Outcomes ### Primary outcomes 1. Dose Limiting Toxicities (DLT) Timeframe: Up to 21Days 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. 2. Adverse Event (AE) Timeframe: Up to 24 Months Number of participants with adverse events that are related to treatment 3. Objective Response Rate Timeframe: Up to 24 Months Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) 4. Maximum tolerated dose (MTD) Timeframe: Up to 24 Months 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 70 Years **Healthy volunteers** No ### Inclusion criteria - Fully understand the study and voluntarily sign the informed consent form. - Male or female 18-70 years of age; - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2; - Life expectancy ≥ 3 months; - Histologically or cytologically confirmed diagnosis of advanced solid tumors. ### Exclusion criteria - Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases; - Any other malignancy within 5 years. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Sites - Zhejiang Cancer HospitalHangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06233292) ## Related records ### Drugs (1) - [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md) ### Lead sponsors (1) - [Suzhou Zelgen Biopharmaceuticals Co.,Ltd](https://trialight.com/data/company/suzhou-zelgen-biopharmaceuticals-co-ltd-632bf22b-0e3b-4d19-a37b-0c680d96ac0a.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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