Refractory or Recurrent CD30+ Hematologic Malignancies Clinical Trial
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.
| Verified date | May 2024 |
| Source | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | March 12, 2024 |
| Est. primary completion date | July 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Cancer Hospital | Beijing | Beijing |
| China | Henan Cancer Hospital | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MTD | the maximum tolerable dose | Within 21 days after a single dose | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Maximum Plasma Concentration [Cmax] | pharmacokinetic parameter | 1 months after last dose | |
| Secondary | Area Under the Curve [AUC] | pharmacokinetic parameter | 1 months after last dose | |
| Secondary | Tmax | pharmacokinetic parameter | 1 months after last dose | |
| Secondary | Half-life Time [T1/2] | pharmacokinetic parameter | 1 months after last dose | |
| Secondary | Clearance [CL] | pharmacokinetic parameter | 1 months after last dose | |
| Secondary | Apparent Volume of Distribution [Vd] | pharmacokinetic parameter | 1 months after last dose | |
| Secondary | Immunogenicity | Anti-F0002-ADC Antibodies | 1 months after last dose | |
| Secondary | Incidence of adverse events | Till 1 month after last dose | ||
| Secondary | Incidence of laboratory abnormalities | Till 1 month after last dose |