NCT04408599终止1 期
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
研究概览
简要总结
This research study is studying a new drug, NC410, as a possible treatment for advanced or metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 or older.
- •Willingness to provide written informed consent for the study.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- •Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. Note: There is no limit to the number of prior treatment regimens.
- •Presence of measurable disease based on RECIST v1.
- •Tumor lesions situated in a previously irradiated area, or in an area subjected to other locoregional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
- •After dose escalation, subject must be willing to undergo pretreatment and on-treatment tumor biopsies (core or excisional). Note: A baseline biopsy obtained for other purposes (i.e., not an NC410-01 study procedure) before signing consent may be utilized if the subject has not had any intervening systemic therapy from the time of the biopsy to the start of treatment with the medical monitor's approval.
- •Female subjects of childbearing potential (defined as women who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy and are not postmenopausal, defined as ≥ 12 months of amenorrhea) must have a negative serum pregnancy test at screening. All female and male subjects of childbearing potential must agree to take appropriate precautions to avoid pregnancy or fathering children (with at least 99% certainty) from screening through 60 days after the last dose of study drug.
排除标准
- •Inability to comprehend or unwilling to sign the Informed Consent Form.
- •Screening laboratory values of:
- •Absolute neutrophil count < 1.5 × 10^9/L
- •Platelets < 100 × 10^9/L
- •Hemoglobin < 9 g/dL or < 5.6 mmol/L
- •Serum creatinine > 1.5 × institutional upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 × ULN
- •Total bilirubin ≥ 1.5 × ULN unless conjugated bilirubin ≤ ULN (conjugated bilirubin only needs to be tested if total bilirubin exceeds ULN). If there is no institutional ULN, then direct bilirubin must be < 40% of total bilirubin.
- •International normalized ratio (INR) or prothrombin time (PT) > 1.5 × ULN
- •Activated partial thromboplastin time (aPTT) > 1.5 × ULN
- •Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before the first administration of study drug.
- •Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
- •≤ 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy. Subjects must also not require chronic use of corticosteroids and must not have had radiation pneumonitis because of a treatment. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease with medical monitor approval. Note: Bisphosphonates and denosumab are permitted medications.
- •≤ 28 days for prior immunotherapy or persistence of active cellular therapy (e.g., chimeric antigen receptor T cell therapy; other cellular therapies must be discussed with the medical monitor to determine eligibility).
- •≤ 28 days for a prior monoclonal antibody used for anticancer therapy except for denosumab.
- •≤ 7 days for immune-suppressive-based treatment for any reason. Note: Use of inhaled or topical steroids or corticosteroid use for radiographic procedures is permitted. Note: The use of physiologic corticosteroid replacement therapy may be approved after consultation with the medical monitor.
- •≤ 28 days or 5 half-lives (whichever is longer) before the first dose for all other investigational study drugs or devices. For investigational agents with long half-lives (e.g., > 5 days), enrollment before the fifth half-life requires medical monitor approval.
- •Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy. Note: Subjects with stable chronic conditions (≤ Grade 2) not expected to resolve (such as neuropathy and alopecia) are exceptions and may enroll. Note: Subjects with a history of any grade immune-related ocular AE (e.g., episcleritis, scleritis, uveitis) will be excluded.
- •Receipt of a live vaccine within 30 days of planned start of study therapy. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- •Active autoimmune disease that required systemic treatment in the past (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Subjects who have not required systemic treatment in the past 2 years may be eligible with approval of the medical monitor. Note: Subjects with hyper/ hypothyroidism are eligible to participate. Note: Replacement and symptomatic therapies (e.g., levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered a form of systemic immune suppressive therapy and are allowed.
- •Known active CNS metastases and/or carcinomatous meningitis. Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 28 days before the first dose of study drug and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases or CNS edema, and have not required steroids for at least 7 days before the first dose of study drug.
- •Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry apart from cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the subject has been disease-free for > 1 year, after treatment with curative intent.
- •Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- •History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
- •Active infection requiring systemic therapy.
- •Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation. HBV-DNA and HCV-RNA must be undetectable. Subjects cannot be positive for HBV-DNA, HCV-RNA, hepatitis B surface antigen, or anti-hepatitis B core antibody. Note: Subjects with no prior history of hepatitis B infection who have been vaccinated against hepatitis B and who have a positive antibody against hepatitis B surface antigen test as the only evidence of prior exposure may participate in the study.
- •Known history of HIV (HIV 1 or HIV 2 antibodies).
- •Known allergy or reaction to any component of study drug or formulation components.
- •Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 60 days after the last dose of study treatment.
研究组 & 干预措施
NC410 3mg
Experimental
3mg of NC410 for IV infusion administered in 14 day dosing cycles
干预措施: NC410 (Drug)
NC410 6mg
Experimental
6mg of NC410 for IV infusion administered in 14 day dosing cycles
干预措施: NC410 (Drug)
NC410 15mg
Experimental
15mg of NC410 for IV infusion administered in 14 day dosing cycles
干预措施: NC410 (Drug)
NC410 30mg
Experimental
30mg of NC410 for IV infusion administered in 14 day dosing cycles
干预措施: NC410 (Drug)
NC410 60mg
Experimental
60mg of NC410 for IV infusion administered in 14 day dosing cycles
干预措施: NC410 (Drug)
NC410 100mg
Experimental
100mg of NC410 for IV infusion administered in 14 day dosing cycles
干预措施: NC410 (Drug)
NC410 200mg
Experimental
200mg of NC410 for IV infusion administered in 14 day dosing cycles
干预措施: NC410 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
时间窗: From enrollment through up to 90 days after end of treatment, an average of 1 year
Number of Participants With Treatment-emergent Adverse Events
次要结局
- Area Under the Curve (AUC) of NC410(Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.)
- Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Approximately 1 year)
- Disease Control Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Approximately 1 year)
- Duration of Response Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors(Approximately 1 year)
- Half-life (t1/2) of NC410(Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.)
- Maximum Plasma Concentration (Cmax) of NC410(Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.)
- Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors(Approximately 1 year)
- Overall Survival (OS) as Assessed by Time of Death(Approximately 1 year)
研究者
研究点 (5)
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