NCT06549816已完成1 期
An Open-label, Phase 1 Study to Investigate the Safety and Pharmacokinetics of SGN-B6A in Chinese Subjects 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
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Number of participants with laboratory abnormalities
研究概览
简要总结
This trial will look at a drug called sigvotatug vedotin (SGN-B6A) to find out whether it is safe for Chinese participants who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how do Chinese participants' body interact with sigvotatug vedotin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subjects must have histologically or cytologically confirmed metastatic or unresectable locally advanced solid malignancy within one of the tumor types listed below.
- •GEJ adenocarcinoma
- •Subjects must have disease that is relapsed or refractory, or be intolerant to systemic standard-of-care therapies, and in the judgement of the investigator, should have no appropriate standard-of-care therapeutic option. If a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented.
- •Adequate organ function as defined by the baseline laboratory criteria obtained within 7 days prior to SGN-B6A initiation (Cycle 1 Day 1)
- •Measurable or non-measurable disease per RECIST v1.1 at baseline.
- •An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
排除标准
- •History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- •Participants with any of the following respiratory conditions:
- •Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that:
- •* Was previous diagnosed and required systemic steroids, or
- •* Is currently diagnosed and managed, or
- •* Is suspected on radiologic imaging at screening
- •Known diffusing capacity of the lung for carbon monoxide (DLCO) < 50%
- •Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated to underlying malignancy
- •Prior radiation therapy to the lung that is >30 gray (Gy) within 6 months of the first dose of sigvotatug vedotin.
- •Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
- •Uncontrolled diabetes mellitus
- •Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:
- •are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
- •have no new or enlarging brain metastases, and
- •are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.
- •Known history or current diagnosis of carcinomatous meningitis
- •Previous treatment with an MMAE-containing agent or an agent targeting integrin beta-6
- •Prior anticancer therapies:
- •Chemotherapy within 21 days prior to first administration of sigvotatug vedotin
- •Targeted small molecule agents within 14 days or 5 half-lives (whichever is longer) prior to first administration of sigvotatug vedotin
- •Antibody-based anticancer or other investigational antitumor therapy within 28 days prior to first administration of sigvotatug vedotin
- •Focal radiotherapy or major surgery that is not completed 14 days prior to the first dose of sigvotatug vedotin
- •Traditional or herbal medicines:
- •Anti-cancer traditional or herbal medicines within 28 days prior to first administration of sigvotatug vedotin
- •Traditional or herbal medicines for other purposes (such as supportive care) within 7 days prior to first administration of sigvotatug vedotin
研究组 & 干预措施
sigvotatug vedotin
Experimental
sigvotatug vedotin monotherapy 1.8 mg/kg adjusted ideal body weight intravenous administration on Days 1 and 15 of a 28-day cycle.
干预措施: sigvotatug vedotin (Drug)
结局指标
主要结局
Number of participants with laboratory abnormalities
时间窗: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with adverse events (AEs)
时间窗: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants with dose-limiting toxicities (DLTs)
时间窗: Up to 28 days
次要结局
- PK of ac-MMAE in plasma: time to maximum concentration (Tmax) after a single dose and multiple doses of SGN-B6A(Single dose: Cycle 1 Day 1 (predose, End of Infusion (EOI), and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days))
- Pharmacokinetics (PK) of antibody-conjugated monomethyl auristatin E (ac-MMAE) in plasma: Area under the curve (AUC) after a single dose and multiple doses of SGN-B6A(Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days))
- PK of ac-MMAE in plasma: maximum concentration (Cmax) after a single dose and multiple doses of SGN-B6A(Single dose: Cycle 1 Day 1 (predose, end of infusion [EOI], and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days))
- PK of ac-MMAE in plasma: apparent half-life (t1/2) after a single dose and multiple doses of SGN-B6A(Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days))
- PK of ac-MMAE in plasma: trough concentration (Ctrough) after a single dose and multiple doses of SGN-B6A(Single dose: Cycle 1 Day 15 predose; Multiple dose: Cycle 2 Day 15 predose (Each Cycle is 28 days))
- PK of monomethyl auristatin E (MMAE) in plasma - AUC after a single dose and multiple doses of SGN-B6A(Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days))
- PK of MMAE in plasma: maximum concentration (Cmax) after a single dose and multiple doses of SGN-B6A(Single dose: Cycle 1 Day 1 (predose, end of infusion [EOI], and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days))
- PK of MMAE in plasma: time to maximum concentration (Tmax) after a single dose and multiple doses of SGN-B6A(Single dose: Cycle 1 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days))
- PK of MMAE in plasma: apparent half-life (t1/2) after a single dose and multiple doses of SGN-B6A(Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days))
- PK of MMAE in plasma: trough concentration (Ctrough) after a single dose and multiple doses of SGN-B6A(Single dose: Cycle 1 Day 15 predose; Multiple dose: Cycle 2 Day 15 predose (Each Cycle is 28 days))
- Number of participants with antidrug antibodies(From first dose through up to 37 days following last dose of sigvotatug vedotin)
研究者
研究点 (3)
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