NL-OMON54125招募中不适用
An open-label, multi-center, Phase I study of oral IAG933 in adult patients with advanced Mesothelioma and other solid tumors - CIAG933A12101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 10
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.Signed informed consent must be obtained prior to participation in the study.
- •2. Male or female patients must be >= 18 years of age
- •3. (dose escalation) Patients with histologically or cytologically confirmed
- •diagnosis of advanced (unresectable or metastatic) mesothelioma or other solid
- •tumors. Patients with solid tumors other than mesothelioma must have local
- •available data for loss-of-function NF2/LATS1/LATS2 genetic alterations
- •(truncating mutation or gene deletion; LATS1/LATS2 mutations will only be
- •included in the dose escalation part), or functional YAP/TAZ fusions (see
- •Appendix 4 for requirements for molecular alterations ). Patients with
- •malignant EHE can be enrolled with only histological confirmation of the
- •disease. Patients must have failed available standard therapies, be intolerant
- •of or ineligible for standard therapy, or for whom no standard therapy exists.
- •4. Dose expansion part: the following patients will be enrolled into 3
- •different treatment groups:
- •Group 1: Advanced (unresectable or metastatic) MPM patients who have failed
- •available standard therapies for advanced/metastatic disease, be intolerant or
- •ineligible to receive such therapy, or for whom no standard therapy exists.
- •Group 2: Advanced (unresectable or metastatic) solid tumor patients with
- •available local data for NF2 truncating mutation or deletions (refer to
- •Appendix 4 for more details). Patient must have failed available standard
- •therapies, be intolerant or ineligible to receive such therapy, or for whom no
- •standard therapy exists.
- •Group 3: Advanced (unresectable or metastatic) solid tumor patients with
- •available local data for functional YAP/TAZ fusions (refer to Appendix 4 for
- •more details). EHE patients can be included with only histological confirmation
- •of the disease. Patient must have failed available standard therapies, be
- •intolerant or ineligible to receive such therapy, or for whom no standard
- •therapy exists.
- •5. Presence of at least one measurable lesion according to mRECIST v1.1 (for
- •mesothelioma patients, refer to Appendix 2), RECIST v1.1 (for patients with
- •other solid tumors, refer to Appendix 1), or RANO (for patients with primary
- •brain tumors, refer to Appendix 3).
- •6. Patient must have a site of disease amenable to biopsy and be a candidate
- •for tumor biopsy according to the treating institution*s guidelines. Patient
- •must be willing to undergo a new tumor biopsy at screening/baseline, and again
- •during therapy on this study. Archival tissue obtained within 3 months and
- •after last systemic treatment may be used at screening. Exceptions may be
- •considered after documented discussion with Novartis.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •1. Treatment with any of the following anti-cancer therapies prior to the first
- •dose of study treatment within the stated timeframes:
- •a. <= 4 weeks for thoracic radiotherapy to lung fields or limited field
- •radiation for palliation within <= 2 weeks prior to the first dose of study
- •treatment. An exception to this exists for patients who have received
- •palliative radiotherapy to bone, who must have recovered from
- •radiotherapy-related toxicities but for whom a 2-week washout period is not
- •b. <= 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.
- •c. <= 6 weeks for cytotoxic agents with risk of major delayed toxicities, such
- •as nitrosoureas and mitomycin C.
- •d. <= 4 weeks for immuno-oncologic therapy, such as CTLA4, PD-1, or PD-L1
- •antagonists
- •e. Prior treatment with TEAD inhibitor at any time
- •2. For mesothelioma patients: use of non-invasive antineoplastic therapy (e.g.,
- •tumor treating fields, brand name Optune LuaTM) within 2 weeks of the tumor
- •assessment at screening.
- •3. Malignant disease, other than that being treated in this study. Exceptions
- •to this exclusion include the following: malignancies that were treated
- •curatively and have not recurred within 2 years prior to study entry;
- •completely resected basal cell and squamous cell skin cancers; any malignancy
- •considered to be indolent and that has never required therapy; and completely
- •resected carcinoma in situ of any type.
- •4. Presence of symptomatic CNS metastases, or CNS tumors or metastases that
- •require local CNS-directed therapy (such as radiotherapy within 3 months of
- •tumor assessment at screening or surgery), or increasing doses of
- •corticosteroids 2 weeks prior to study entry.
- •Patients with treated symptomatic brain tumors should be neurologically stable
- •(for 4 weeks post-treatment and prior to study entry) and at a dose of <= 10 mg
- •per day prednisone or equivalent for at least 2 weeks before administration of
- •any study treatment
- •5. Patients who have undergone major surgery <= 4 weeks prior to first dose of
- •study treatment
- •6. History of allogeneic bone marrow or solid organ transplant.
- •7. Insufficient renal function at Screening:
- •a. Serum creatinine > 1.5 x ULN
- •b. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 (calculated
- •using the Cockcroft-Gault formula, or the CKD-EPI Creatinine-Cystatin C formula
- •as listed in Appendix 7).
- •c. Urine protein-creatinine ratio > 0.5 g/g (56.5 mg/mmol)
- •8. Clinically significant cardiac disease or risk factors at screening,
- •including any of the following:
- •a. Clinically significant and/or uncontrolled heart disease, including coronary
- •artery disease, uncontrolled hypertension, clinically significant arrhythmia,
- •and congestive heart failure (NYHA grade >= 2).
- •b. Acute myocardial infarction or unstable angina pectoris within 6 months
- •prior to study entry.
- •c. Left ventricular ejection fraction (LVEF) < 50% as determined by
- •Cardiovascular magnetic resonance imaging (cardiac magnetic resonance imaging
- 另有 3 项未显示
研究者
相似试验
招募中
1 期
Phase I study of IAG933 in patients with advanced Mesothelioma and other solid tumorspatients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ fusionJPRN-jRCT2031210340Yamauchi Kyosuke10
进行中（未招募）
1 期
A Phase 2 clinical trial of orally taken investigational product (called MLN9708) in adult patients with returning and/or not responding Follicular LymphomaMedDRA version: 14.1Level: LLTClassification code 10029478Term: Nodular lymphomaSystem Organ Class: 100000004864Follicular LymphomaEUCTR2013-002302-32-ITMillennium Pharmaceuticals, Inc.58
进行中（未招募）
1 期
A Phase 2 clinical trial of orally taken investigational product (called MLN9708) in adult patients with returning and/or not responding Follicular LymphomaFollicular LymphomaMedDRA version: 17.0 Level: LLT Classification code 10029478 Term: Nodular lymphoma System Organ Class: 100000004864EUCTR2013-002302-32-GBMillennium Pharmaceuticals, Inc.29
进行中（未招募）
1 期
A Phase 2 clinical trial of orally taken investigational product (called MLN9708) in adult patients with returning and/or not responding Follicular LymphomaFollicular LymphomaMedDRA version: 19.0Level: LLTClassification code 10029478Term: Nodular lymphomaSystem Organ Class: 100000004864EUCTR2013-002302-32-ESMillennium Pharmaceuticals, Inc.58
进行中（未招募）
1 期
A Phase 2 clinical trial of orally taken investigational product (called MLN9708) in adult patients with returning and/or not responding Follicular LymphomaFollicular LymphomaEUCTR2013-002302-32-BEMillennium Pharmaceuticals, Inc.58