NCT07807345尚未招募1 期
A Phase 1 Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO 006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 285
- 试验地点
- 7
- 主要终点
- Part 1B: Objective Response Rate (ORR)
研究概览
简要总结
This study is a first-in-human (FIH) Phase 1 open-label, multicenter study including three parts:
- Part 1A is a dose escalation of STRO-006 monotherapy in selected tumor types reported to commonly express ITGB6. Part 1A will determine the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of STRO-006.
- Part 1B is a dose expansion in one or more indications, as determined by the Sponsor, to further evaluate a STRO-006 monotherapy dose, examine anti-tumor activity, and determine the recommended Phase 2 dose (RP2D) of STRO-006 monotherapy.
- Part 1C is a combination dose escalation to determine safety, tolerability, PK, and preliminary anti-tumor activity of STRO-006 combined with pembrolizumab.
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
- •Histologically or cytologically documented refractory solid tumors that are recurrent or metastatic including: HNSCC (excluding EBV-positive nasopharyngeal carcinoma), NSCLC, esophageal/gastric cancer, colorectal cancer, endometrial carcinoma, urothelial carcinoma, and breast cancer (HR-positive [HER2-positive or HER2-negative] and TNBC subtype)
- •Age ≥ 18 years
- •Life expectancy of at least 3 months
- •Willingness and ability to comply with the study protocol and long
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1-term follow-up (LTFU) assessments
- •Has received standard systemic therapies with known clinical benefit, or is considered inappropriate for such therapies, in the opinion of the investigator. In the dose escalation Phases (Parts 1A and 1C), there is no limit on the number of prior therapies
- •Expansion Phase (Part 1B) only: Up to two prior therapies are allowed. For participants with AGA-driven adenocarcinoma NSCLC up to four prior therapies are allowed
- •Measurable disease per RECIST v1.
- •Adequate hematologic and organ function
排除标准
- •Prior anticancer treatment with an ADC with a TOP1 inhibitor payload. (Prior therapy with an ITGB6-targeted ADC is otherwise allowed.)
- •Prior anticancer therapy (prior to first dose of study treatment): chemotherapy within ≤ 2 weeks, ICI ≤ 3 weeks, ADCs ≤ 3 weeks, palliative radiation therapy ≤ 2 weeks, and major surgery ≤ 4 weeks of C1D
- •If not specified, ≥ 5 half-lives or 2 weeks, whichever is longer, since administration of prior therapy must have elapsed
- •Residual Common Terminology Criteria for Adverse Events (CTCAE) v5 ≥ Grade 2 toxicity from prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 peripheral neuropathy, which is controlled, and endocrinopathies secondary to prior ICI controlled by hormonal treatment. For Part 1C only: discontinued prior immunotherapy due to treatment-related toxicity
- •Untreated or active brain metastases and/or leptomeningeal disease
- •Participants with active ILD or active, non-infectious pneumonitis or a history of active pneumonitis ≤ 6 months from the first dose of study treatment
- •Significant, concurrent renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease that could impact participation in this clinical trial
- •Previous solid organ or bone marrow transplantation
- •Concurrent participation in another therapeutic treatment trial
研究组 & 干预措施
Part 1A STRO-006 monotherapy
Experimental
干预措施: STRO-006 (Drug)
Part 1B STRO-006 monotherapy
Experimental
干预措施: STRO-006 (Drug)
Part 1C STRO-006 in combination with pembrolizumab
Experimental
干预措施: STRO-006 (Drug)
Part 1C STRO-006 in combination with pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Part 1B: Objective Response Rate (ORR)
时间窗: 2.5 years
Part 1B: Disease control rate (DCR)
时间窗: 2.5 years
Part 1B: Duration of Response (DOR)
时间窗: 2.5 years
Part 1B: Progression-Free Survival (PFS)
时间窗: 2.5 years
Part 1A, 1C: Incidence and severity of Dost-limiting Toxicities (DLTs)
时间窗: 21 days
Part 1A, 1C: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
时间窗: 21 days
Part 1B: Rate of OS12
时间窗: 12 months
Part 1B: Incidence and severity of treatment emergent adverse events and serious adverse events
时间窗: 21 days
次要结局
- Part 1A, Part 1B, Part 1C: Standard PK parameters for the ADC, total antibody, and exatecan payload following single- and repeat-dose administration.(2.5 years)
- Part 1A, Part 1B, Part 1C: Incidence of circulating ADA over time(2.5 years)
- Part 1A, 1C: Objective Response rate (ORR)(2.5 years)
- Part 1A, Part 1C: Disease control rate (DCR)(2.5 years)
- Part 1A, Part 1C: Duration of Response (DOR)(2.5 years)
- Part 1A, Part 1C: Progression-Free Survival (PFS)(2.5 years)
- Part 1A, Part 1C: Rate of OS12(1 year)
研究者
研究点 (7)
Loading locations...
相似试验
招募中
1 期
A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative NeoplasmsNCT07469891Prelude Therapeutics Incorporated100
招募中
1 期
A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid TumorsTriple Negative Breast Cancer (TNBC)HR+ Breast CancerHepatecellular CarcinomaNSCLC (Advanced Non-small Cell Lung Cancer)Pancreatic Carcinoma MetastaticHormone Refractory Prostate CancerSoft Tissue SarcomasGastric CancerColon CancerMesotheliomaNCT07705334SHY Therapeutics30
尚未招募
1 期
XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid TumorsMetastatic NSCLC - Non-Small Cell Lung CancerAdvanced Solid TumorNCT07688577Xilio Development, Inc.140
尚未招募
1 期
Phase I Study of SM2275 Injection in Patients With Advanced Solid TumorsAdvanced Solid TumorsMetastatic Solid TumorsNCT07750132Beijing StarMab Biomed Technology Ltd72
招募中
1 期
A Phase I First-in-Human Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of SWA1211 Tablets in Subjects With Advanced Solid TumorsNCT07363967Beijing StoneWise Technology Co., Ltd60