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CompletedNCT03894150Updated May 14, 2024

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

A Phase 1 interventional study of F0002-ADC in Refractory or Recurrent CD30+ Hematologic Malignancies, sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Refractory or Recurrent CD30+ Hematologic Malignancies
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 45 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. is the lead sponsor of 24 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    F0002-ADC

    Drug: F0002-ADC

Interventions

  • DrugF0002-ADC

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

06

What researchers measure

Primary outcomes

  1. MTD

    the maximum tolerable dose

    Time frame: Within 21 days after a single dose

Secondary outcomes

  1. ORR

    Objective response rate

    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

  2. DOR

    Duration of Response

    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

  3. PFS

    Progress Free Survival

    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

  4. Maximum Plasma Concentration [Cmax]

    pharmacokinetic parameter

    Time frame: 1 months after last dose

  5. Area Under the Curve [AUC]

    pharmacokinetic parameter

    Time frame: 1 months after last dose

  6. Tmax

    pharmacokinetic parameter

    Time frame: 1 months after last dose

  7. Half-life Time [T1/2]

    pharmacokinetic parameter

    Time frame: 1 months after last dose

  8. Clearance [CL]

    pharmacokinetic parameter

    Time frame: 1 months after last dose

  9. Apparent Volume of Distribution [Vd]

    pharmacokinetic parameter

    Time frame: 1 months after last dose

  10. Immunogenicity

    Anti-F0002-ADC Antibodies

    Time frame: 1 months after last dose

  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

07

Study locations

2 sites
  • Beijing Cancer Hospital
    Beijing, Beijing 100142, China
  • Henan Cancer Hospital
    Zhengzhou, Henan 450008, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03894150
Lead sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 28, 2019
Start date
Apr 11, 2019
Primary completion
Jul 1, 2020
Completion
Mar 12, 2024
Last update
May 14, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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