A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.2 sites in 1 country45 target enrollmentApril 11, 2019

ConditionsRefractory or Recurrent CD30+ Hematologic Malignancies

InterventionsF0002-ADC

DrugsF0002-ADC

Overview

Phase: Phase 1
Intervention: F0002-ADC
Conditions: Refractory or Recurrent CD30+ Hematologic Malignancies
Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Enrollment: 45
Locations: 2
Primary Endpoint: MTD
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 11, 2019

End Date

March 12, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status 0 or
•With relapsed/refractory CD30+ disease that histologically confirmed by central laboratory assessment and pathology review (Priority for cHL, ALCL and MF).
•Patients must have at least one site of measurable disease by conventional CT scan (defined by unidimensional lymph node lesion ≥ 15 mm or extranodal lesion ≥ 10 mm ), patients with MF, skin nodules can be measured by caliper to meet the criteria as measurable lesions, positive FDG uptake for cHL and ALCL.
•Patients must have the following required baseline laboratory data: Hb≥80g/L, NEUT≥1.5×109/L, PLT≥75×109/L, TBIL≤1.5 times ULN, ALT/AST≤2.5 times ULN, Cr≤1.25 times ULN or Ccr≥45 ml/min, INR≤1.5 times ULN, APTT≤1.5 times ULN.
•Patients must be at least 8 weeks apart from the previous autologous stem cell infusion therapy prior to the first dose.
•Patients must be at least 4 weeks apart from previous radiotherapy, chemotherapy, biologics, immunotherapy, and/or other research-based anticancer therapy prior to the first dose (with nitrogen mustard, melphalan, and nitrosourea for at least 6 weeks).
•Patients must have a life expectancy \> 3 months.
•Voluntary consent form

Exclusion Criteria

•Patients who have received an allogeneic stem cell transplant.
•Patients who have had previous treatment with any anti-CD30 antibody.
•Patients received antibody therapy 6 weeks or 5 plasma half-life before the first dose.
•Patients who are receiving other anti-tumor treatments.
•The toxicity of previous anti-tumor treatment has not recovered to grade 1 or below, except for grade 2 peripheral neurotoxicity and any level of alopecia.
•Other primary malignant tumors have been seen in the past 3 years (except for cervical cancer in situ or non-melanoma skin cancer or prostate cancer with specific prostate specific antigen).
•Participants with cardiovascular conditions specified in protocols.
•NYHA classification grading of cardiac function III/IV.
•Participants with brain or meningeal disease conditions specified in protocols.
•Patients with poor diabetes control,

Arms & Interventions

F0002-ADC

Intervention: F0002-ADC

Outcomes

Primary Outcomes

MTD

Time Frame: Within 21 days after a single dose

the maximum tolerable dose

Secondary Outcomes

Incidence of adverse events(Till 1 month after last dose)
Incidence of laboratory abnormalities(Till 1 month after last dose)
Maximum Plasma Concentration [Cmax](1 months after last dose)
Tmax(1 months after last dose)
ORR(Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years)
PFS(Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years)
Area Under the Curve [AUC](1 months after last dose)
Half-life Time [T1/2](1 months after last dose)
Clearance [CL](1 months after last dose)
Apparent Volume of Distribution [Vd](1 months after last dose)
Immunogenicity(1 months after last dose)
DOR(Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years)