NL-OMON52294招募中不适用
A Phase 1 Open-Label, Dose Escalation and Expansion Trial to Investigate the Safety, pharmacokinetics and Pharmacodynamics of CB307, a Trispecific Humabody® T-cell Enhancer, in Patients with PSMA+ Advanced and/or Metastatic Solid Tumours (POTENTIA) - POTENTIA
Crescendo Biologics Limited0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Capable of understanding the written informed consent, provides signed and
- •witnessed written informed consent and agrees to comply with protocol
- •requirements.
- •2. Aged at least 18 years at the time of signing informed consent.
- •3. Has documented histologically confirmed diagnosis of advanced or metastatic
- •solid tumours.
- •4.Meets at least one of the following PSMA-based eligibility criteria:
- •For patients with non-prostate cancer:
- •At least one of the following:
- •a. PSMA positivity by IHC in an FFPE sample obtained prior to the initiation of
- •study enrolment (defined as availability of a representative archived
- •pre-treatment tumour specimen for submission to central reader). Brushing, cell
- •pellet from ascites or pleural effusion or lavage samples are not acceptable.
- •Samples of bone lesion or samples that require a decalcification procedure are
- •acceptable.
- •b. PSMA positivity by IHC in a fresh tumour biopsy sample set in formalin
- •including decalcification of bone metastases (brushing, cell pellet from
- •pleural effusion or lavage samples are not acceptable) obtained prior to
- •initiation of study treatment for submission to central reader.
- •-Provision of fresh tumour samples is a preferable option even if FFPE is
- •available and site can submit both FFPE and fresh samples.
- •For patients with prostate cancer:
- •At least one of the following:
- •a.Documented PSMA+ lesion determined by local PSMA-PET scan obtained between
- •the last anti-cancer treatment and prior to commencing CB307 study treatment.
- •-Note that while a positive PSMA test result by IHC is not required for
- •eligibility if PSMAPET positive status is confirmed locally, provision of a
- •fresh tissue sample or archival tumour sample is still requested form
- •retrospective PSMA-IHC analysis on-study.
- •b.PSMA positivity by IHC in an FFPE newly obtained biopsy or archival sample
- •prior to the initiation of study enrolment. Brushing, cell pellet from ascites
- •or pleural effusion or lavage samples are not acceptable.
- •Samples of bone lesion or samples that require a decalcification procedure are
- •acceptable.
- •-Provision of fresh tumour samples is a preferable option even if FFPE is
- •available; sites may submit both FFPE and fresh samples.
- •5. Has an Eastern Cooperative Oncology Group Performance Status 0 or1.
- •6. Has adequate organ function.
- •For further information, please refer to the clinical protocol.
排除标准
- •- Has evidence of autoimmune or significant, uncontrolled concomitant diseases
- •that could affect compliance with the protocol or interpretation of results.
- •- Has discontinued from anti-cytotoxic lymphocyte-associated protein 4,
- •anti-PD1 or anti-PD-L1 antibody because of intolerable toxicity according to
- •the investigator*s assessment.
- •- Has brain metastasis including leptomeningeal metastasis or primary brain
- •- Has encephalitis, meningitis, or uncontrolled seizures in the year prior to
- •informed consent.
- •- Has current or history of CNS disease, such as stroke, epilepsy, CNS
- •vasculitis or a neurodegenerative disease.
- •- Has uncontrolled pleural effusion, pericardial effusion or ascites that
- •require regular recurrent drainage procedures.
- •- Is currently receiving bisphosphonate therapy for symptomatic hypercalcaemia.
- •- Has active second malignancy.
- •-Has significant cardiovascular/cerebrovascular vascular disease within 6
- •months prior to the first dose of CB307, including any of the following:
- •hypertensive
- •crisis/encephalopathy, uncontrolled hypertension (systolic >150 mm Hg and/or
- •diastolic >100 mm Hg), unstable angina, transient ischaemic attack/stroke,
- •congestive heart failure (NYHA III or greater), serious cardiac arrhythmia
- •requiring treatment (exceptions are atrial fibrillation, paroxysmal
- •supraventricular tachycardia), history of thromboembolic events (such as
- •myocardial infarction, stroke or pulmonary embolism).
- •- Has known HIV-1, HBV or HCV infection.
- •- Has known active or uncontrolled bacterial, viral, fungal, mycobacterial,
- •parasitic or other infection (excluding fungal infections of nail beds) or any
- •major episode of infection requiring treatment with IV antibiotics or
- •hospitalisation (relating to the completion of the course of antibiotics,
- •except if for tumour fever) within 28 days prior to the first dose of CB307.
- •- Has a history of chronic liver disease or evidence of hepatic cirrhosis.
- •- Has any other diseases, metabolic dysfunction, physical examination finding
- •or clinical laboratory finding that give reasonable suspicion of a disease or
- •condition that would contraindicate the use of an investigational drug or that
- •may affect the interpretation of the results or render the patient at high risk
- •from treatment complications, in the opinion of the investigator.
- •- Has had major surgery or significant traumatic injury within 28 days prior to
- •the first dose of CB307 (excluding biopsies) or anticipation of the need for
- •major surgery during study treatment or 3 months after the last dose.
- •- Administered a live attenuated vaccine within 28 days prior to the first dose
- •of CB307 or anticipation that such a live attenuated vaccine will be required
- •during the study or 3 months after the last dose.
- •- Has dementia or altered mental status that would prohibit informed consent.
- •- Has a known hypersensitivity to any of the components of CB307 or history of
- •severe hypersensitivity reactions to antibodies (NCI CTCAE v5.0 grade >=3).
- •- Adverse events (grade 1 or baseline) not recovered from previous anticancer
- •- Last dose with any of the following agents: etanercept, infliximab,
- •tacrolimus, cyclosporine, mycophenolic acid, alefacept, efalizumab or similar
- •systemic immune modulator within 28 days or 5 half-lives, whichever is longer,
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