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

S

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase

Enrolling
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

23 estimated 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

F0002-ADC
Experimental group
Treatment:
Drug: F0002-ADC

Trial contacts and locations

0

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Central trial contact

JUN ZHU, MD; YUQIN SONG, MD

Data sourced from clinicaltrials.gov

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