A Study of ZG005 in Patients With Advanced Solid Tumors

NCT06233292
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Phase
Phase 1/Phase 2
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Recruitment status
Unknown
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Participants
484
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Lead sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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Start date
2022-06-17
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Number of sites
1
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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.
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Short title
A Study of ZG005 in Patients With Advanced Solid Tumors
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Official title
A Phase 1/2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2026-01-01
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First posted
2024-01-31
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Registry last updated
2024-06-14
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Primary completion date
2026-01-01
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Start date
2022-06-17
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Participants
484
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Participant count basis
Estimated
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Planned participants
484
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06233292
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ClinicalTrials.gov ID
NCT06233292
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  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
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No

  • 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.

  • 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
clinicaltrials.gov

  • Zhejiang Cancer HospitalHangzhou, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)