NL-OMON56048招募中不适用
A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Participants with Advanced or Metastatic Solid Tumors - D9570C00001 (study with AZD7789)
Astra Zeneca0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
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
- •General Inclusion Criteria for all cohorts:
- •Must be >= 18 years of age
- •Part A, B1, B2 and B3: Histologically or cytologically documented Stage IIIB
- •to IV non-small cell lung carcinoma (NSCLC) not amenable to curative surgery or
- •Part B4: Histologically or cytologically documented advanced or metastatic
- •gastric and GEJC not amendable to curative surgery
- •Must have at least one measurable lesion according to Response Evaluation
- •Criteria in Solid Tumors (RECIST) v1.1
- •Provision of fresh tumor tissue sample and consent to undergo mandatory
- •on-treatment biopsy for participants enrolled in Part A Dose-escalation
- •participants
- •Provision of archival tumor tissue sample or fresh tissue sample for Part B
- •Dose-expansion participants
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •Non-pregnant women and willingness of female participants to avoid pregnancy
- •or male participants willing to avoid fathering children through highly
- •effective methods of contraception
- •Adequate organ and bone marrow function measured within 28*days prior to
- •first dose.
- •Part A Dose Escalation Additional Inclusion Criteria:
- •May have squamous or non-squamous NSCLC
- •Must have received at least one prior line of systemic therapy, of which at
- •least one prior line of therapy contained approved anti-PD-1/PD-L1
- •Must have had immune-oncology (IO) acquired resistance
- •PD-L1 <1% of >1% documented
- •Part B Dose Expansion Cohort B1 and B3 Additional Inclusion Criteria:
- •May have squamous or non-squamous NSCLC
- •Must have received at least one prior line of systemic therapy, of which only
- •one prior line of therapy contained approved anti-PD-1/PD-L1
- •Must have had IO acquired resistance
- •PD- L1 expression >= 1% as determined by IHC
- •Part B Dose Expansion Cohort B2 Additional Inclusion Criteria:
- •May have squamous or non-squamous NSCLC
- •Must not have received prior systemic therapy including IO therapy in the
- •first-line setting
- •PD-L1 expression >= 50% as determined by IHC
- •Part B Dose Expansion Cohort B4 Additional Inclusion Criteria:
- •Must not have received at least one but no more than two prior lines of
- •systemic therapy in the advanced/metastatic setting, of which only one prior
- •line of therapy contained an approved anti-PD-1/PD-L1 therapy
- •Must have had IO acquired resistance
- •There are no PD-L1 status requirements for this cohort
排除标准
- •Patients with sensitizing epidermal growth factor receptor (EGFR) mutations
- •or anaplastic lymphoma kinase (ALK) fusions
- •Documented test result for any other known genomic alteration for which a
- •targeted first line therapy is approved per local standard of care (SoC)
- •Part B dose-expansion Cohort B4: documented HER2 amplification (unless an SoC
- •including an anti-HER2 therapy has been received)
- •Unresolved toxicities of >= Grade 2 from prior therapy
- •Any prior >= Grade 3 immune-mediated adverse event (imAE) while receiving
- •immunotherapy or any unresolved imAE >= Grade 2
- •Must not have experienced a toxicity that led to permanent discontinuation of
- •prior immunotherapy
- •Symptomatic central nervous system (CNS) metastasis or leptomeningeal disease
- •History of symptomatic and objectively confirmed arterial (including
- •myocardial infarction) or venous thromboembolic event within 6 months prior to
- •study drug dosing, unless participant is on treatment with adequate
- •antithrombotic medication and is considered to be stable by the investigator.
- •History of organ transplant or allogenic hematopoietic stem cell transplant.
- •Infectious disease exclusions: Active infection including TB, HIV, hepatitis
- •A, chronic or active hepatitis B, chronic or active hepatitis C, active
- •COVID-19 infection
- •History of clinically significant arrhythmia as judged by the Investigator.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or
- •active infection, cardiomyopathy of any etiology, symptomatic congestive heart
- •failure, uncontrolled hypertension, uncontrolled diabetes mellitus, unstable
- •angina pectoris, history of myocardial infarction within the past 6 months,
- •serious chronic gastrointestinal conditions associated with diarrhea, active
- •non infectious skin disease. For Part B Dose-expansion Cohort B4,
- •medication-resistant ascites requiring drainage in the last 28 days prior the
- •start of AZD7789 and/or the occurrence of active gastro-intestinal bleeding, as
- •judged by the Investigator.
- •Active or prior documented autoimmune or inflammatory disorders, including
- •inflammatory bowel disease (eg, colitis or Crohn's disease), diverticulitis
- •(with the exception of diverticulosis), systemic lupus erythematosus,
- •Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis),
- •Graves' disease, rheumatoid arthritis, Hypophysitis, uveitis, etc.. Some
- •exceptions have been specified in the protocol.
- •Past medical history of interstitial lung disease (ILD), drug-induced ILD,
- •radiation pneumonitis requiring steroid treatment, or any evidence of
- •clinically active ILD
- •Major surgical procedure within 28 days prior to the first dose of study
- •intervention or still recovering from prior surgery
- •Other invasive malignancy within 2 years prior to screening
- •Congenital long QT syndrome or history of QT prolongation associated with
- •other medications that cannot be changed or discontinued based on a
- •cardiologist assessment
- •Any previous treatment with anti-TIM-3 therapy in any setting is not
- •permitted. For Part A, B1 and B3: treatment with investigational therapy prior
- •to initiation of study treatment except where the most recent line of therapy
- •was investigational agents added to approved anti-PD-1/PD-L1 as part of
- •standard of care. Investigational agents
研究者
相似试验
招募中
1 期
A study to assess the safety and efficacy of AZD7789 in participants with advanced or metastatic solid cancerCTIS2022-502774-17-00AstraZeneca AB192
进行中（未招募）
1 期
A study to assess the safety and efficacy of AZD7789 in participants with advanced or metastatic solid cancerAdvanced or Metastatic Non-small Cell Lung CarcinomaSolid TumorsEUCTR2021-000036-57-NLAstraZeneca AB81
进行中（未招募）
1 期
study to evaluate the safety of the study drug, GSK2857916, at different doses and how well it works to treat people with multiple myeloma when taken together with Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B).Relapsed / Refractory Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2017-004689-93-GBGlaxoSmithKline Research & Development Ltd152
进行中（未招募）
1 期
study to evaluate the safety of the study drug, GSK2857916, at different doses and how well it works to treat people with multiple myeloma when taken together with Lenalidomide Plus Dexamethasone (Treatment Arm A), or Bortezomib Plus Dexamethasone (Treatment Arm B).EUCTR2017-004689-93-ESGlaxoSmithKline Research & Development Ltd90
进行中（未招募）
1 期
A Phase I/II Study of AZD5863 in Adult Participants with Advanced or Metastatic Solid TumorsCTIS2023-504139-42-00AstraZeneca AB200