NCT04362748已完成1 期
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 256 in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 34
- 试验地点
- 11
- 主要终点
- Number of Participants with Dose Limiting Toxicities (DLTs)
研究概览
简要总结
To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- •Age ≥ 18 years at the time of signing informed consent.
- •Life expectancy of > 3 months, in the opinion of the investigator.
- •Participant must have histologically or cytologically proven metastatic or locally advanced solid tumors not amenable to curative treatment with surgery or radiation for which:
- •No standard therapy exists, or
- •Standard therapy has failed, not available, or
- •In the investigator's opinion, standard therapy does not result in meaningful clinical benefit.
- •At least 1 measurable lesion ≥ 10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study.
排除标准
- •Primary brain tumor, untreated or symptomatic brain metastases and leptomeningeal disease.
- •History of other malignancy within the past 2 years, with the following Exceptions:
- •Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- •Adequately treated cervical carcinoma in situ without evidence of disease.
- •Adequately treated breast ductal carcinoma in situ without evidence of disease.
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- •Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
- •History of solid organ transplantation.
- •Major surgery within 28 days of study day
- •Live vaccine therapy within 4 weeks prior to study day
- •Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- •Active infection requiring oral or intravenous therapy.
- •Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or cardiac arrhythmia requiring medication.
- •History of severe allergic reactions or severe acute hypersensitivity reaction.
- •Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of AMG
- •Female participants of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 3 months after the last dose of AMG
- •Female participants of childbearing potential with a positive pregnancy test assessed within 48 hours prior to day 1 of treatment by a serum pregnancy test.
- •Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 5 months after the last dose of AMG
- •Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 5 months after the last dose of AMG
- •Male participants unwilling to abstain from donating sperm during treatment and for an additional 5 months after the last dose of AMG
- •Participant has known sensitivity to any of the products or components to be administered during dosing.
- •Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
- •History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participants safety or interfere with the study evaluation, procedures or completion.
研究组 & 干预措施
Dose Escalation Phase
Experimental
Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose RP2D of AMG 256.
干预措施: AMG 256 (Drug)
Dose Expansion Phase: Group 1
Experimental
Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.
干预措施: AMG 256 (Drug)
Dose Expansion Phase: Group 2
Experimental
Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.
干预措施: AMG 256 (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicities (DLTs)
时间窗: 28 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 2.5 Years
Maximum Tolerated Dose (MTD) of AMG 256
时间窗: 28 days
Number of Participants with Treatment-Related Adverse Events
时间窗: Up to 2.5 Years
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement
时间窗: Up to 2 Years
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
时间窗: Up to 2 Years
Recommended Phase 2 Dose (RP2D) of AMG 256
时间窗: 28 days
次要结局
- Duration of Stable Disease(Up to 2.5 Years)
- Overall Survival (OS)(Up to 2 Years)
- Objective Response (OR)(Up to 2.5 Years)
- Progression-Free Survival (PFS)(Up to 1 Year)
- Disease Control Rate (DCR)(Up to 2.5 Years)
- Maximum Observed Plasma Concentration (Cmax) of AMG 256(Up to 2.5 Years)
- Area Under the Plasma Concentration-time Curve (AUC) of AMG 256(Up to 2.5 Years)
- Time to Achieve Cmax (Tmax) of AMG 256(Up to 2.5 Years)
- Duration of Response (DOR)(Up to 2.5 Years)
- Number of Participants with anti-AMG 256 Antibodies(Up to 2.5 Years)
研究者
研究点 (11)
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