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

NCT ID: NCT03894150

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2024-03-12

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.

Conditions

Refractory or Recurrent CD30+ Hematologic Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

F0002-ADC

Group Type: EXPERIMENTAL

F0002-ADC

Intervention Type: DRUG

Every 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg

Interventions

F0002-ADC

Every 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

F0002-01

Identifier Type: -

Identifier Source: org_study_id