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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03894150
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Refractory or Recurrent CD30+ Hematologic Malignancies Drug: F0002-ADC Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : March 1, 2024

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




Primary Outcome Measures :
  1. MTD [ Time Frame: Within 21 days after a single dose ]
    the maximum tolerable dose


Secondary Outcome Measures :
  1. ORR [ Time Frame: Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years ]
    Objective response rate

  2. DOR [ Time Frame: Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years ]
    Duration of Response

  3. PFS [ Time Frame: Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years ]
    Progress Free Survival

  4. Maximum Plasma Concentration [Cmax] [ Time Frame: 1 months after last dose ]
    pharmacokinetic parameter

  5. Area Under the Curve [AUC] [ Time Frame: 1 months after last dose ]
    pharmacokinetic parameter

  6. Tmax [ Time Frame: 1 months after last dose ]
    pharmacokinetic parameter

  7. Half-life Time [T1/2] [ Time Frame: 1 months after last dose ]
    pharmacokinetic parameter

  8. Clearance [CL] [ Time Frame: 1 months after last dose ]
    pharmacokinetic parameter

  9. Apparent Volume of Distribution [Vd] [ Time Frame: 1 months after last dose ]
    pharmacokinetic parameter

  10. Immunogenicity [ Time Frame: 1 months after last dose ]
    Anti-F0002-ADC Antibodies

  11. Incidence of adverse events [ Time Frame: Till 1 month after last dose ]
  12. Incidence of laboratory abnormalities [ Time Frame: Till 1 month after last dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894150


Contacts
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Contact: JUN ZHU, MD +86 10 88121122 zhujun@csco.org.cn
Contact: YUQIN SONG, MD +86 10 88121122 songyuqin622@163.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: LIANSHUN ZHOU, BA    +86 10 88196391    zhoushunlian@163.com   
Sponsors and Collaborators
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
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Responsible Party: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03894150    
Other Study ID Numbers: F0002-01
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases