Clinical trial NCT03894150: A Study of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Refractory or Recurrent CD30+ Hematologic Malignancies
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* 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,
* High-risk participants with a history of \> grade 2 peripheral neuropathy or any active neurologic disease.
* Patients have psychiatric history.
* Patients with a history of liver fibrosis or cirrhosis and clinical signs and symptoms suggesting liver fibrosis or cirrhosis.
* Patients with previous interstitial pneumonia.
* Patients have active systemic viral, bacterial or fungal infection 4 weeks prior to the first dose
* HIV antibody positive / HBsAg positive / HCVAb positive.
* Patients who are allergic to recombinant proteins, murine proteins or to the drug excipients.
* Patients who are receiving a dose ≥ 20 mg/day of prednisone or glucocorticoid therapy.
* Female patients who are breastfeeding or pregnant.
* Patients with fertility who refuses to use contraception during the trial period and within 6 months after the end of the last dose.
* Other reasons that researchers believe are inappropriate to participate in this study.

Primary outcomes:
measure: MTD
timeFrame: Within 21 days after a single dose
Secondary outcomes:
measure: ORR
timeFrame: Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years
measure: DOR
timeFrame: Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years
measure: PFS
timeFrame: Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years
measure: Maximum Plasma Concentration [Cmax]
timeFrame: 1 months after last dose
measure: Area Under the Curve [AUC]
timeFrame: 1 months after last dose
measure: Tmax
timeFrame: 1 months after last dose
measure: Half-life Time [T1/2]
timeFrame: 1 months after last dose
measure: Clearance [CL]
timeFrame: 1 months after last dose
measure: Apparent Volume of Distribution [Vd]
timeFrame: 1 months after last dose
measure: Immunogenicity
timeFrame: 1 months after last dose
measure: Incidence of adverse events
timeFrame: Till 1 month after last dose
measure: Incidence of laboratory abnormalities
timeFrame: Till 1 month after last dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
References: