NL-OMON53721招募中2 期
A Phase I/II, multi-center, open label study of DYP688 in patients with MUM and other GNAQ/11 mutant melanomas (study CDYP688A12101) - CDYP688A12101
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 7
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
- •Patients in the dose escalation part must be >=18 years of age at the time of
- •informed consent (ICF) signature. In the phase Il part, patients >=12 years of
- •age at the time of informed consent may be eligible for enrollment (for
- •Netherlands only >=18 years of age are eligible). Patients must have a minimum
- •weight of 40 kg.
- •ECOG performance status <=1 for patients >=18 years of age; Karnofsky
- •performance status >=70
- •Patients must be suitable and willing to undergo study required biopsies
- •according to the treating institution's own guidelines and requirements.
- •For all patients in Dose Escalation:
- •MUM: uveal melanoma with histologically or cytologically confirmed metastatic
- •disease. Patient must be either treatment naive or have received any number of
- •prior lines and progressed on most recent therapy.
- •Non-MUM: advanced cutaneous or mucosal melanoma with histologically or
- •cytologically confirmed metastatic disease that has progressed following all
- •therapies or that has no satisfactory alternative therapies and has evidence of
- •GNAQ/11 mutation based on local data.
- •For patients in Phase Il:
- •Tebentafusp naïve group: Diagnosis of uveal melanoma with histologically or
- •cytologically confirmed metastatic disease that has progressed following
- •standard therapies or that has no satisfactory alternative therapies.
- •Tebentafusp pre-treated group: Diagnosis of uveal melanoma with
- •histologically or cytologically confirmed metastatic disease. Patients must be
- •previously treated with tebentafusp and have progressed.
- •Non-MUM: patients with diagnosis of cutaneous or mucosal melanomas harboring
- •GNAQ/11 mutations based on local data, with histologically or cytologically
- •confirmed metastatic disease that has progressed following all standard
- •therapies or that has no satisfactory alternative therapies.
排除标准
- •Malignant disease, other than that being treated in this study.
- •Active brain metastases, i.e. symptomatic brain metastases or known
- •leptomeningeal disease.
- •Evidence of active bleeding or bleeding diathesis or significant coagulopathy
- •(including familial) or a medical condition requiring long term systemic
- •anticoagulation that would interfere with biopsies.
- •History of anaphylactic or other severe hypersensitivity / infusion reactions
- •to antibody-drug conjugate or monoclonal antibodies, which in the opinion of
- •the investigator may pose an increased risk of serious infusion reaction.
- •Treatment with any of the following anti-cancer therapies prior to the first
- •dose of study treatment within the stated timeframes:
- •<=2 weeks tor fluoropyrimidine therapy
- •<=4 weeks for radiation therapy or limited field radiation for palliation
- •within <=2 weeks prior to the first dose of study treatment.
- •* <=4 weeks or <=5 half-lives (whichever is shorter) for chemotherapy or
- •biological therapy (including monoclonal antibodies) or continuous or
- •intermittent small molecule therapeutics or any other investigational agent.
- •<=6 weeks for cytotoxic agents with major delayed toxicities, such as
- •nitrosourea compounds and mitomycin C.
- •<=4 weeks for immuno-oncologic therapy, such as CTLA-4, PD-1, or PD-L1
- •antagonists.
- •Clinically significant and / or uncontrolled heart disease such as congestive
- •heart failure requiring treatment (NYHA grade >=2) or clinically significant
- •arrhythmia despite medical treatment.
研究者
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