A Study of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Refractory or Recurrent CD30+ Hematologic Malignancies

Treatments

Drug: F0002-ADC

Study type

Interventional

Funder types

Industry

Identifiers

NCT03894150

F0002-01

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.