A Study of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.
Phase 1
Completed
- Conditions
- Refractory or Recurrent CD30+ Hematologic Malignancies
- Interventions
- Registration Number
- NCT03894150
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description F0002-ADC F0002-ADC -
- Primary Outcome Measures
Name Time Method MTD Within 21 days after a single dose the maximum tolerable dose
- Secondary Outcome Measures
Name Time Method Incidence of adverse events Till 1 month after last dose Incidence of laboratory abnormalities Till 1 month after last dose Maximum Plasma Concentration [Cmax] 1 months after last dose pharmacokinetic parameter
Tmax 1 months after last dose pharmacokinetic parameter
ORR 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
PFS 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
Area Under the Curve [AUC] 1 months after last dose pharmacokinetic parameter
Half-life Time [T1/2] 1 months after last dose pharmacokinetic parameter
Clearance [CL] 1 months after last dose pharmacokinetic parameter
Apparent Volume of Distribution [Vd] 1 months after last dose pharmacokinetic parameter
Immunogenicity 1 months after last dose Anti-F0002-ADC Antibodies
DOR 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
Trial Locations
- Locations (2)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China