Evaluate Safety, Tolerability and PK of HLX55 in Patients With Advanced Solid Tumors With Different cMET Status
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Solid Tumor, Adult
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This study is an open-label and dose escalation study including dose finding stage and expansion stage. In dosing finding stage, the study will precede in two phases, (i) a modified accelerated titration design 2A (ATD 2A) phase and (ii) a traditional 3+3 dose escalation phase aimed at exploring the...
This study is an open-label and dose escalation study including dose finding stage and expansion stage. In dosing finding stage, the study will precede in two phases, (i) a modified accelerated titration design 2A (ATD 2A) phase and (ii) a traditional 3+3 dose escalation phase aimed at exploring the safety and MTD of HLX55. Four dose levels are designed for HLX55 in this stage: 2.5, 5, 15, and 25 mg/kg/3 weeks. The 5 mg/kg/3 weeks will serve as the starting dose. In the dose-expansion stage, three to five cohorts are planned, and different cohorts will evaluate the efficacy of HLX55 for potential indications. Maximum 20 patients will be accrued in each cohort.
Tracking Information
- NCT #
- NCT04169178
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Tsu-Yi Chao, MD. PhD. Shuang Ho Hospital,Ministry of Health and Welfare, Taipei, Taiwan Principal Investigator: Ching-Liang Ho, MD Tri-Service General Hospital, Taipei, Taiwan Principal Investigator: Wu-Chou Su, MD. PhD. National Cheng Kung University Hospital, Tainan, Taiwan Principal Investigator: Chia-Lun Chang, MD Taipei Municipal Wanfang Hospital, Taipei, Taiwan
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