NL-OMON52007招募中不适用
An open label, multicentre, positron emission tomography (PET) imaging study using Zirconium-89 to investigate the biodistribution and tumor uptake of a PD-L1x4-1BB bispecific antibody (S095012) in patients with advanced solid tumors - Immuno-PET study of 89Zr-S095012 in subject with advanced solid tumors.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 33
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. Men and women of >= 18 years of age on the day the consent is signed.
- •2. Participants with histologically confirmed diagnosis of unresectable,
- •locally advanced or metastatic solid tumor for which standard treatment options
- •are not available, no longer effective, or not tolerated. Participant should
- •have a documented disease progression on prior therapy before entry into this
- •3. Participants must have at least one measurable target lesion as per RECIST
- •4. ECOG performance status of 0 or 1
- •5. For participants in part B/C (optional for part A): Participant with no
- •available archived material must have one or more tumor lesions amenable to
- •biopsy. Baseline biopsies are not mandatory if archived tumor biopsy specimens
- •collected no later than 9 months before screening, are available. If no
- •archived material is available, a fresh biopsy must be collected at baseline.
- •6. Adequate organ function as assessed by laboratory tests within 72 hours
- •prior to the first IMP administration:
- •- Absolute neutrophil count (ANC) >= 1500/µL.
- •- Platelet count >= 75 000/µL (this criterion must be met without transfusion
- •and thrombopoietin for at least two weeks prior to IMP administration).
- •- Haemoglobin >= 8 g/dL (this criterion must not be met with the use of
- •transfusion and erythropoietin for at least two weeks prior to IMP
- •administration).
- •- Glomerular filtration rate (GFR) or measured or calculated creatinine
- •clearance (CrCl) >= 30 mL/min using the Cockcroft and Gault formula.
- •Alternatively, the GFR can be estimated using the Modification of Diet in Renal
- •Disease (MDRD) formula. However, the estimation of CrCl must be done using the
- •same methodology for a given participant (see Appendix 5).
- •- Total bilirubin <= 1.5×upper limit of reference range (ULN) (or total serum
- •bilirubin <3×ULN for participants with Gilbert*s disease).
- •- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5×ULN.
- •- Serum albumin >= 3 g/dL
- •7. Woman must use a highly effective method of birth control during study
- •treatment and until 120 days after last dose of IMP
- •In case of use of oral contraception, women should have been stable on the same
- •contraceptive drug (same active principle) for at least 6 months prior to the
- •first IMP administration.
- •8. A male participant with childbearing potential partners must use a condom
- •during the study and until at least 120 days after the last dose of IMP.
- •Participants that are sterile or vasectomised must use a condom during sexual
- •intercourse with a childbearing potential partner in order to avid exposure of
- •an existing embryo/foetus. In addition, contraception should be considered for
- •their female partner. Contraceptive measures do not apply if the participant is
- •sterile, vasectomized or sexual abstinent. Sperm donation will not be allowed
- •during the study and for 120 days after the last dose of IMP.
- •9. Human immunodeficiency virus (HIV)-infected participants must have
- •well-controlled HIV or be on adequate antiretroviral therapy defined as:
- • CD4 lymphocyte count > 350 cells/µL at time of screening.
- • Achieving and maintaining virologic suppression defined as confirmed HIV
- •ribonucleic acid (RNA) level below 50 or lower limit of detection by the local
- •available assay at time of screening and for at least 12 weeks prior to
排除标准
- •11. Pregnant and lactating women.
- •12. Unlikely to cooperate in the study.
- •13. Participation in another interventional study at the same time;
- •participation in non-interventional registries or epidemiological studies is
- •14. Participant already included in the study (informed consent signed).
- •15. Participants with previously treated brain metastases may participate
- •provided they are radiologically stable, clinically asymptomatic and are off
- •immunosuppressive therapies for at least 4 weeks. Low dose of steroid < 10
- •mg/day prednisone or equivalent is allowed.
- •16. Participants with primary central nervous system malignancies.
- •17. Participants with Child-Pugh Class B8 or higher or C liver cirrhosis.
- •18. Participants who have received prior:
- •a. chemotherapy, Small molecule inhibitors, and/or other similar
- •investigational agent: <= 2 weeks or 5 half-lives, whichever is shorter.
- •b. monoclonal antibodies, antibody-drug conjugates, or other similar
- •experimental therapies: <= 3 weeks or 5 half-lives, whichever is shorter.
- •c. Radioimmunoconjugates or other similar experimental therapies <= 6 weeks or 5
- •half-lives, whichever is shorter.
- •19. Participants must have recovered from any AE (from previous anti-cancer
- •therapy) to Grade 1 or lower by Common Terminology Criteria for Adverse Events
- •(CTCAE) v5.0. Grade 2 neuropathy is acceptable. Participants receiving
- •replacement hormone therapy due to previous AEs will not be excluded from
- •participation in this study if the associated AE has recovered to Grade 1 with
- •replacement therapy prior to the first IMP administration.
- •20. Participants who have received 4-1BB agonists in the past.
- •21. Participants who had a major surgery within 4 weeks prior to first
- •administration of IMP.
- •22. Participants with an active autoimmune disease that is currently requiring
- •systemic anti inflammatory treatment such as disease-modifying anti-rheumatic
- •drugs, steroids, or immunosuppressants), except vitiligo, alopecia areata,
- •asthma/atopy and psoriasis treated and controlled by topical therapies.
- •Participants with auto-immune endocrinopathies that are well treated by
- •replacement hormones therapies (e.g. thyroxine, insulin, physiological steroids
- •for adrenal or pituitary deficits) are eligible.
- •23. Participants with a history of immune related AEs from a previous line of
- •treatment must have recovered Grade <= 1 and have stopped any
- •immunosuppressive/steroid therapy. Participants with prior history of Grade >= 3
- •immune-related pneumonitis, colitis, hepatitis, myocarditis.
- •24. Participants receiving systemic steroids at a dose of more than 10 mg per
- •day equivalent of prednisone. Ocular, inhaled, intranasal, topical steroids are
- •allowed. Local steroid injections (intra-articular and/or epidural) are
- •allowed as a palliative therapeutic option only.
- •25. Participants who have received an allogenic solid organ or bone marrow
- •transplant.
- •26. Participants with a history of interstitial lung disease, pneumonitis
- •requiring systemic steroids for treatment, or current pneumonitis.
- •27. Participants with a clinically significant cardiovascular disease or
- •condition, including:
- •a. New York Heart Association classification III or IV, known symptomatic
- •coronary artery disease, or symptoms of coronary artery disease on systems
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