EUCTR2021-001789-39-ES进行中（未招募）1 期
A Phase 1 and 2a open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of LAVA-1207, a PSMA-targeting bispecific ?d-T cell engager, in patients with therapy refractory metastatic castration resistant prostate cancer
AVA Therapeutics N.V.0 个研究点目标入组 66 人开始时间: 2022年3月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Patients are eligible to be included in the trial only if all of the following criteria apply:
- •1. Patient must be 18 years of age inclusive or above, at the time of signing the informed consent.
- •2. Male patient with mCRPC as defined by PCWG3 criteria (histologically confirmed adenocarcinoma; adenocarcinoma with =10% small-cell or neuroendocrine features is allowed). Brain metastasis are allowed as long as the patient’s symptoms are well controlled.
- •3. Patient should have failed at least 1 line of taxane-based chemotherapy or is deemed medically unsuitable to be treated with a taxane regimen.
- •4. Patient should have received a 2nd generation or later androgen receptor targeted therapy/ androgen biosynthesis inhibitor (e.g. abiraterone, enzalutamide, and/or apalutamide). Progression on novel antiandrogen therapy may have occurred in the non-metastatic CRPC setting.
- •5. Patients will be unlikely to tolerate or derive clinically meaningful benefit from other available therapy.
- •6. Patients for which any drug related toxicity adverse effects of any prior cancer therapy should have resolved to Grade 1 or less according CTCAE v5.0 or to baseline severity level.
- •7. Patients with evidence of progressive disease, defined as 1 or more criteria:
- •a. PSA level =1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
- •b. Computed tomography (CT) or magnetic resonance imaging (MRI) scan: nodal or visceral
- •progression as defined by RECIST 1.1.
- •c. Bone scintigraphy: appearance of 2 or more new metastatic lesions.
- •8. Patient should have undergone bilateral orchiectomy or should be on continuous androgen-deprivation therapy (ADT) with a gonadotropin-releasing hormone agonist or antagonist (surgical or medical castration).
- •9. Total serum testosterone = 50 ng/dL or 1.73 nmol/L.
- •10. Measurable or evaluable disease:
- •Part 1-Dose escalation: Either measurable or evaluable disease for prostate cancer.
- •Part 2-Expansion cohort: At least one measurable lesion as per RECIST v1.1.
- •11. Predicted life-expectancy of = 6 months.
- •12. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •13. Adequate renal (estimated glomerular filtration rate [eGFR] per local laboratory> 40 mL/min/1.73m2), hepatic (bilirubine 1 x109/L,
- •platelet count > 75x109/L).
- •14. Males who are:
- •a. Surgically sterile (bilateral orchiectomy, vasectomy)
- •b. Compliant with an effective contraceptive regimen (i.e. use of male condom with female partner and assuring use of an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant following from signing of the informed consent form [ICF] through 90 days after the last IMP administration) from signing of the ICF through 90 days after the last IMP administration). Abstinence is not considered an adequate contraceptive regimen.
- •c. Refraining from donating sperm following from signing of the ICF through 90 days after the last IMP administration.
- •15. Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures that are not considered Standard of Care which includes compliance with the requir
排除标准
- •Patients are excluded from the trial if any of the following criteria apply:
- •1. Other malignancies within the last 2 years except adequately treated carcinoma in situ, basal or squamous cell skin carcinoma.
- •2. Uncontrolled or severe intercurrent medical condition.
- •3. Positive serological testing for human immunodeficiency virus (HIV) antibody.
- •4. Positive serological hepatitis B surface antigen [HBsAg] and hepatitis B core antibody (anti-HBc) negative, and hepatitis C virus antibody. Patients who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative polymerase chain reaction (PCR) within 6 weeks prior to initial IMP administration. Those who are PCR positive will be excluded.
- •5. Patient has any active-, uncontrolled-, or suspected infection.
- •6. Known clinically relevant immunodeficiency disorders.
- •7. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect participation in this trial.
- •8. Unstable cardiovascular function defined as: (a) symptomatic ischemia, or (b) uncontrolled clinically significant conduction abnormalities (i.e. ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block is not excluded), or (c) congestive heart failure New York Heart Association Class = 3, or (d) myocardial infarction within 3 months.
- •9. Previous treatment with antitumor therapies 2 weeks prior to initial IMP for radiotherapy and 4 weeks for systemic chemotherapy or poly (ADP-ribose) polymerase (PARP) inhibitor.
- •10. Previous treatment with live or live attenuated vaccines within 2 weeks prior to initial IMP administration. New types of vaccines need to be evaluated as to their mode of action.
- •11. Treatment with other investigational agents in the 4 weeks prior to initial IMP.
- •12. Major surgery within 4 weeks prior to dosing.
- •13. Hypersensitivity to any of the excipients present in the IMP.
- •14. Previous treatment with any systemic immunosuppressant within 4 weeks prior to initial IMP administration, with the exception of systemic corticosteroid use up to oral dose of 10 mg prednisone daily (or equivalent for other steroids).
- •15. Previous treatment with an aminobisphosphonate IV (e.g. ibandronate, pamidronate, zoledronate etc) within 4 weeks prior to initial IMP.
- •16. Part 2 only: previous treatment with (and progression on) a PSMA targeting agents.
- •17. Known ongoing drug and alcohol abuse in the opinion of the investigator.
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