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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Refractory or Recurrent CD30+ Hematologic Malignancies
• Intervention / Treatment: Drug: F0002-ADC

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: JUN ZHU, MD; Phone Number: +86 10 88121122; Email: zhujun@csco.org.cn
• Study Contact Backup: Name: YUQIN SONG, MD; Phone Number: +86 10 88121122; Email: songyuqin622@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: LIANSHUN ZHOU, BA; Phone Number: +86 10 88196391; Email: zhoushunlian@163.com
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Not yet recruiting
      • Henan Cancer Hospital
      • Contact: Baoxia He, ph.D; Email: baoxia_he@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: F0002-ADC	Drug: F0002-ADC; Every 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTD	the maximum tolerable dose	Within 21 days after a single dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate	Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years
DOR	Duration of Response	Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years
PFS	Progress Free Survival	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]	pharmacokinetic parameter	1 months after last dose
Area Under the Curve [AUC]	pharmacokinetic parameter	1 months after last dose
Tmax	pharmacokinetic parameter	1 months after last dose
Half-life Time [T1/2]	pharmacokinetic parameter	1 months after last dose
Clearance [CL]	pharmacokinetic parameter	1 months after last dose
Apparent Volume of Distribution [Vd]	pharmacokinetic parameter	1 months after last dose
Immunogenicity	Anti-F0002-ADC Antibodies	1 months after last dose
Incidence of adverse events		Till 1 month after last dose
Incidence of laboratory abnormalities		Till 1 month after last dose

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2019
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (ACTUAL): March 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Disease Attributes; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Recurrence
• Other Study ID Numbers: F0002-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No