EUCTR2021-001789-39-NL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, alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer
AVA Therapeutics N.V.0 个研究点目标入组 82 人开始时间: 2021年6月15日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 82
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
- •Inclusion criteria (for patients treated with LAVA-1207 +/- LDSC IL-2):
- •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 (except for alopecia or peripheral neuropathy).
- •7. Patients has evidence of progressive disease, defined as 1 or more of the following 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 androgendeprivation 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. Evaluable (measurable or non-measurable) disease for prostate cancer.
- •11. Predicted life-expectancy of = 6 months.
- •Inclusion criteria for LAVA-1207 plus pembrolizumab arm:
- •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 metastases are allowed as long as the patient's symptoms are well controlled, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- •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 anti-androgen therapy may have occurred in the non-mCRPC setting.
- •5. Patient is unlikely to tolerate or derive clinically meaningful benefit from other available therapy.
- •6. Patient for which any drug-related toxicity adverse effects of any prior cancer therapy should have resolved to Grade 1 or less according CTCAE version 5.0 or to baseline severity level (except alopecia or peripheral neuropathy).
- •7. Patient has evidence of progressive disease, defined as 1 or more of the following c
排除标准
- •Exclusion Criteria (for patients treated with LAVA-1207 +/- LDSC IL-2):
- •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 within 2 weeks prior to initial IMP for radiotherapy and androgen receptor targeted therapy/androgen biosynthesis inhibitor, and within 4 weeks for systemic chemotherapy or targeted immunotherapy.
- •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 administration.
- •12. Major surgery within 4 weeks prior to initial IMP administration.
- •13. Hypersensitivity to any of the excipients present in LAVA-1207 or IL-2 (if applicable).
- •Exclusion Criteria for LAVA-1207 plus pembrolizumab arm:
- •1. Other malignancies within the last 2 years except adequately treated carcinoma in situ, basal or squamous cell skin carcinoma.
- •2. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV). Patients who are HbsAg negative and HBV viral DNA negative are eligible. Patients who had HBV but have received an antiviral treatment and show non-detectable viral DNA for 6 months are eligible.
- •Patients who are seropositive because of HBV vaccine are eligible.
- •3. Seropositive for and with active viral infection with hepatitis C virus (HCV). Patients who had HCV but have received an antiviral treatment and show no detectable HCV viral DNA for 6 months are eligible.
- •4. History of allogenic tissue or solid organ transplant.
- •5. Positive serological testing for HIV.
- •6. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
- •7. Hypersensitivity to any of the excipients present in LAVA-1207.
- •8. Active infection requiring systemic therapy.
- •9. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •10. Has a diagnosis of immunodeficiency or is receiving chronic systemi
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