a study of f0002-adc in chinese patients with refractory or recurrent cd30+ hematologic malignancies.

Conditions: Refractory or Recurrent CD30+ Hematologic Malignancies

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.


Eligibility 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.