NCT07559929招募中1 期
A Phase Ib/II Study to Evaluate the Safety and Efficacy of DXC006 for Injection Combined With Immune Checkpoint Inhibitors or Platinum-Based Agents in Patients With Small Cell Lung Cancer.
Hangzhou DAC Biotechnology Co., Ltd.2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年8月19日最近更新:
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
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Measurement of objective response rate (ORR) per RECIST 1.1
研究概览
简要总结
This is a Phase Ib/II, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in patients with small cell lung cancer (SCLC).
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 informed consent and willingness to comply with the protocol requirements.
- •Male or female.
- •Age ≥18 years and ≤75 years.
- •Life expectancy ≥3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Histologically or cytologically confirmed small cell lung cancer (SCLC).
- •Toxicity from prior anti-tumor therapy has resolved to ≤ Grade 1 as defined by NCI-CTCAE version 6.0 (except alopecia); peripheral neuropathy must have completely resolved.
- •Adequate hepatic, renal, coagulation, and cardiac function.
- •The participant and their spouse agree to use effective barrier or pharmacologic contraception (excluding rhythm method) from the time of signing the informed consent until 6 months after the last dose of study treatment.
排除标准
- •Histologically or cytologically confirmed combined SCLC, NSCLC, sarcomatoid carcinoma, or large cell neuroendocrine carcinoma.
- •Within 14 days prior to the first dose: underwent plasmapheresis; received systemic corticosteroid therapy at a daily dose >10 mg prednisone or equivalent (or equivalent anti-inflammatory activity) for more than 3 consecutive days (short-term use for prevention of contrast media allergy is permitted).
- •Prior allogeneic hematopoietic stem cell transplantation (HSCT) or history of solid organ transplantation.
- •Prior treatment with CD56-targeted therapy.
- •Symptomatic brain metastases or leptomeningeal metastases.
- •History of severe or life-threatening immune-related adverse events or infusion-related reactions (including permanent discontinuation of immuno-oncology therapy due to intolerance).
- •Active autoimmune disease or immunodeficiency, or a history of such conditions.
- •Evidence of significant cardiovascular risk.
- •Dyspnea or current requirement for continuous supplemental oxygen therapy, or current active pneumonitis or interstitial lung disease (except mild cases as determined by the investigator).
- •History of other primary malignancies, with the exception of malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
- •Severe non-healing wound, ulcer, or bone fracture; or major surgery within 28 days prior to dosing, or anticipated major surgery during the study period.
- •History of hypersensitivity to any component or excipient of DXC006, immune checkpoint inhibitors, or platinum-based chemotherapy.
- •Active hepatitis B (HBV-DNA above the upper limit of normal at the central laboratory or >1000 copies/mL); hepatitis C infection (positive hepatitis C antibody or positive HCV RNA PCR result).
- •Known positive serology for human immunodeficiency virus (HIV); active syphilis (patients with positive syphilis antibody only are eligible); potential active pulmonary tuberculosis (chest imaging within 3 months prior to the first dose suggestive of active tuberculosis infection).
- •Active bleeding within 30 days prior to screening, or risk of major gastrointestinal bleeding or hemoptysis as determined by the investigator; or hereditary bleeding tendency, coagulopathy, or bleeding symptoms requiring other medical intervention.
- •Severe arterial or venous thromboembolic events within 6 months prior to study drug administration, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.
- •Positive serum pregnancy test or currently breastfeeding female participants.
- •Active infection requiring medical therapy (CTCAE Grade ≥2); uncontrollable pleural effusion, ascites, or pericardial effusion requiring repeated drainage.
- •Administration of live attenuated vaccines within 28 days prior to the first dose.
- •Other conditions that, in the judgment of the investigator, may affect the patient's participation in the study.
- •Poor general condition, such as requirement for mechanical ventilation and/or intravenous catecholamine infusion, and/or severe neurological impairment, coma, and/or quadriplegia with complete loss of communication ability (deafness, blindness, aphasia); uncontrolled seizures; other psychiatric disorders that may affect study participation.
研究组 & 干预措施
DXC006 + ICI
Experimental
干预措施: Toripalimab (Drug)
DXC006 + Platinum(Cisplatin )
Experimental
干预措施: Cisplatin (Drug)
DXC006 + ICI
Experimental
干预措施: DXC006 (Drug)
DXC006 + Platinum(Carboplatin )
Experimental
干预措施: DXC006 (Drug)
DXC006 + Platinum(Carboplatin )
Experimental
干预措施: Carboplatin (Drug)
DXC006 + Platinum(Cisplatin )
Experimental
干预措施: DXC006 (Drug)
结局指标
主要结局
Measurement of objective response rate (ORR) per RECIST 1.1
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Progression Free Survival (PFS)
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
6-month progression-free survival rate
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Recommended Phase 2 Dose (RP2D)
时间窗: Final RP2D confirmation upon completion of the Phase Ib (up to 12 months).
Measurement of disease control rate (DCR)
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Incidence of Adverse Events (AEs)
时间窗: After first infusion of study drug, through study completion an average of 2 year.
次要结局
- Maximum observed serum or plasma concentration (Cmax)(Through study completion an average of 1 year.)
- Maximum serum drug time（Tmax）(Through study completion an average of 1 year.)
- Apparent volume of distribution(Vd)(Through study completion an average of 1 year.)
- Volume of distribution at steady state (Vss)(Through study completion an average of 1 year.)
- Terminal phase elimination half life (t½)(Through study completion an average of 1 year.)
- Area under the serum or plasma concentration time curve from 0 to the last measurable point (AUC0-t).(Through study completion an average of 1 year.)
- Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)(Through study completion an average of 1 year.)
- Clearance (CL)(Through study completion an average of 1 year.)
- Ctrough(Through study completion an average of 1 year.)
- Anti-drug antibodies (ADA)(Through study completion an average of 1 year.)
- Overall Survival (OS)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.)
- Duration of response (DOR)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.)
研究者
研究点 (2)
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