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

NCT03894150 | Completed Phase 1

• 1 other identifier: F0002-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• MTD

  the maximum tolerable dose

  Within 21 days after a single dose

Secondary Outcomes (12)

• ORR

  Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years

• DOR

  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

• Maximum Plasma Concentration [Cmax]

  1 months after last dose

• Area Under the Curve [AUC]

  1 months after last dose

Study Arms (1)

F0002-ADC

EXPERIMENTAL

Drug: F0002-ADC

Interventions

F0002-ADC DRUG

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

F0002-ADC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: April 11, 2019
• Primary Completion: July 1, 2020
• Study Completion: March 12, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CN (2)