A Phase 1 interventional study of F0002-ADC in Refractory or Recurrent CD30+ Hematologic Malignancies, sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
This is a Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive hematologic malignancies.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: F0002-ADC
Every 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg
MTD
the maximum tolerable dose
Time frame: Within 21 days after a single dose
ORR
Objective response rate
Time frame: Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years
DOR
Duration of Response
Time frame: Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years
PFS
Progress Free Survival
Time frame: Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years
Maximum Plasma Concentration [Cmax]
pharmacokinetic parameter
Time frame: 1 months after last dose
Area Under the Curve [AUC]
pharmacokinetic parameter
Time frame: 1 months after last dose
Tmax
pharmacokinetic parameter
Time frame: 1 months after last dose
Half-life Time [T1/2]
pharmacokinetic parameter
Time frame: 1 months after last dose
Clearance [CL]
pharmacokinetic parameter
Time frame: 1 months after last dose
Apparent Volume of Distribution [Vd]
pharmacokinetic parameter
Time frame: 1 months after last dose
Immunogenicity
Anti-F0002-ADC Antibodies
Time frame: 1 months after last dose
Incidence of adverse events
Time frame: Till 1 month after last dose
Incidence of laboratory abnormalities
Time frame: Till 1 month after last dose
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.