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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

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.