NCT07115043招募中1 期
A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select 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
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 120
- 试验地点
- 14
- 主要终点
- Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion)
研究概览
简要总结
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
详细描述
A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants with Select Advanced or Metastatic Solid Tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Participant ≥ 18 year
- •ECOG PS of 0 to 1
- •Provision of 'archival' tumor specimen
- •At least one measurable lesion according to RECIST v1.1,
- •Minimum life expectancy of 12 weeks
- •Adequate and stable cardiac function
- •Adequate bone marrow, liver and kidney function
- •Body weight ≥ 35 kg
- •Capable of giving signed informed consent
- •Module 1 specific inclusion criteria:
- •Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer/gastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC
- •Module 2 specific inclusion criteria:
- •Participants with Stage IV NSCLC Dose Escalation/Backfills
- •Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR
- •Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
- •Dose Expansion
- •Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
排除标准
- •Any evidence of:
- •Severe or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions
- •History or planned organ or allogeneic stem cell transplantation.
- •Active or prior documented autoimmune or inflammatory disorders, within the past 3 years
- •Any prior toxicities that led to permanent discontinuation of prior immunotherapy
- •Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy
- •Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids
- •Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.
- •Active uncontrolled or chronic infection of hepatitis B, hepatitis C
- •Prior history of Grade ≥ 3 non-infectious pneumonitis.
- •Participant requires chronic immunosuppressive therapy (including steroids > 10 mg prednisone/day or equivalent).
- •Receipt of live attenuated vaccine within 30 days.
- •Module 2 specific exclusion criteria:
- •Previous treatment with anti-TIGIT therapy
- •1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC
研究组 & 干预措施
Module 1
Experimental
AZD6750 administered intravenously (IV) as a single agent
干预措施: AZD6750 (Drug)
Module 2
Experimental
AZD6750 given in combination with rilvegostomig (IV)
干预措施: AZD6750 (Drug)
Module 2
Experimental
AZD6750 given in combination with rilvegostomig (IV)
干预措施: rilvegostomig (Drug)
结局指标
主要结局
Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion)
时间窗: Measured from the informed consent until Day 90 post-last dose.
To assess the safety and tolerability, characterize the DLTs, and determine the MTD and RP2D(s) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module
Efficacy- Part 2B only (dose expansion)
时间窗: Measured every 6 weeks for 48 weeks and every 12 weeks thereafter from first dose until disease progression or death in the absence of disease progression(approximately 2 years)
To assess the preliminary anti-tumor activity of AZD6750 in combination with other anti-cancer agents.
次要结局
- Pharmacodynamic- Part 1A & Part 2A (dose escalation) and Part B (dose expansion)(Measured with baseline and On-treatment biopsy. On-treatment biopsy is planned during Cycle 2 during Cycle 2 (each cycle is 28 days or 21 days depending on Module/dosing schedule))
- Immunogenicity- Part 1A & 2A (dose escalation) and Part 2B (dose expansion)(Measured from pre-infusion on Cycle 1 up to Day 28 post last dose. Each cycle is 28 days or 21 days depending on Module/dosing schedule).)
- Efficacy (Part 1A and 2A)(Measured every 6 weeks for 48 weeks and every 12 weeks thereafter thereafter from first dose until disease progression or death in the absence of disease progression (approximately 2 years))
- PK Maximum plasma concentration (Cmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)(Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals)
- PK Area Under Curve (AUC)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)(Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals)
- PK Time to maximum plasma concentration (tmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)(Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals)
- PK Clearance- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)(Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals)
- PK Half-life- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)(Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals)
- PK Minimum observed concentration (Cmin)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)(Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals)
研究者
研究点 (14)
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