A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 596
- 主要终点
- Dose-Limiting Toxicity (DLT) (Phase Ib)
研究概览
简要总结
This is an open-label, multi-cohort, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of SYS6090 injection in combination with chemotherapy or chemotherapy and bevacizumab or SYS6010 (an EGFR ADC) in participants with advanced lung cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed written informed consent.
- •Age 18 to 75 years at the time of informed consent, with no restriction on sex.
- •Histologically or cytologically confirmed unresectable locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) according to the AJCC/UICC Cancer Staging System, 8th edition, or extensive-stage small cell lung cancer (SCLC), not amenable to curative surgical resection or definitive chemoradiotherapy.
- •At least one measurable lesion according to RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Estimated life expectancy of at least 3 months.
- •Has protocol-defined adequate organ and bone marrow function.
排除标准
- •Use of systemic corticosteroids or other immunosuppressive therapies within 14 days prior to the first dose of study treatment, except for physiologic replacement doses or permitted local, inhaled, or prophylactic use.
- •Unresolved > Grade 1 toxicities related to prior anticancer therapy (except for toxicities judged by the investigator to pose no safety risk).
- •For Cohorts 5A and 5B: prior permanent discontinuation of EGFR-targeted therapy due to dermatologic toxicity, or presence of dermatologic diseases requiring systemic treatment.
- •Known active central nervous system metastases or leptomeningeal metastases, except for stable and adequately treated brain metastases without the need for ongoing corticosteroids or antiepileptic therapy.
- •History of interstitial lung disease or non-infectious pneumonitis requiring corticosteroid treatment; current ILD or non-infectious pneumonitis; or inability to exclude these conditions at screening.
- •History of severe cardiovascular or cerebrovascular disease.
- •Active or recurrent autoimmune disease requiring systemic treatment, except for clinically stable or well-controlled conditions as specified in the protocol.
- •Prior immunotherapy associated with severe immune-related adverse events (≥ Grade 3) or immune-related myocarditis (≥ Grade 2), excluding stable immune-related endocrine disorders.
- •Clinically significant bleeding events (≥ Grade 2 according to NCI-CTCAE v6.0) within 4 weeks prior to the first dose of study treatment.
- •Arterial or venous thromboembolic events within 6 months prior to the first dose of study treatment, unless judged by the investigator to be clinically stable and low risk.
- •Presence of ascites or pleural effusion requiring drainage within 14 days prior to the first dose.
- •Known hypersensitivity to any component of the study treatment, history of severe hypersensitivity or infusion-related reactions to protein-based therapies, or poorly controlled asthma.
- •Untreated spinal cord compression.
- •History of other malignancies within 2 years prior to enrollment or concurrent active malignancy, except for cured localized tumors. -
研究组 & 干预措施
SYS6090 + Pemetrexed + Platinum
SYS6090 combined with pemetrexed and platinum-based chemotherapy in participants with driver gene-negative non-squamous non-small cell lung cancer (nsqNSCLC).
干预措施: SYS6090 + pemetrexed + platinum-based chemotherapy (Drug)
SYS6090 + Paclitaxel + Platinum
SYS6090 combined with paclitaxel and platinum-based chemotherapy in participants with driver gene-negative squamous non-small cell lung cancer (sqNSCLC).
干预措施: SYS6090 + paclitaxel + platinum-based chemotherapy (Drug)
SYS6090 + Docetaxel
SYS6090 combined with docetaxel in participants with driver gene-negative non-small cell lung cancer (NSCLC).
干预措施: SYS6090 + docetaxel (Drug)
SYS6090 + Pemetrexed + Bevacizumab + Platinum
SYS6090 combined with pemetrexed, bevacizumab, and platinum-based chemotherapy in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC).
干预措施: SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy (Drug)
SYS6090 + SYS6010 (nsqNSCLC)
SYS6090 combined with SYS6010 in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC).
干预措施: SYS6090 + SYS6010 (Drug)
SYS6090 + SYS6010 (NSCLC)
SYS6090 combined with SYS6010 in participants with driver gene-negative non-small cell lung cancer (NSCLC).
干预措施: SYS6090 + SYS6010 (Drug)
SYS6090 + Etoposide + Platinum
SYS6090 combined with etoposide and platinum-based chemotherapy in participants with small cell lung cancer (SCLC).
干预措施: SYS6090 + etoposide + platinum-based chemotherapy (Drug)
SYS6090 + Chemo/Other Anticancer Therapy
SYS6090 combined with chemotherapy or other novel anticancer therapies in participants with lung cancer.
干预措施: SYS6090 + chemotherapy or other anticancer therapy (Drug)
结局指标
主要结局
Dose-Limiting Toxicity (DLT) (Phase Ib)
时间窗: Approximately 21 days.
To evaluate the safety of SYS6090 in participants.
Adverse Events (AEs) (Phase Ib)
时间窗: Up to 90 days after the last administration
To evaluate the safety of SYS6090 combination therapy in participants.
Objective response rate (ORR) (Phase II)
时间窗: Through out the study (up to 2 years)
ORR is defined as the proportion of participants in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is observed as best overall response.
次要结局
- Cmax of SYS6090 (and SYS6010 if applicable)(Through out the study (up to 2 years))
- AUC0-t of SYS6090 (and SYS6010 if applicable)(Through out the study (up to 2 years))
- Clearance (CL) of SYS6090 (and SYS6010 if applicable)(Through out the study (up to 2 years))
- Other Efficacy Endpoints Assessed by RECIST v1.1 (DoR, DCR, TTR, PFS, and OS)(Through out the study (up to 2 years))
- Adverse Events (AEs) (Phase II)(Through out the study (up to 2 years))
- Correlation between Biomarker Levels and Preliminary Efficacy(Through out the study (up to 2 years))