NCT07612137尚未招募1 期
A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBI3005 Combination Therapy in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 282
- 试验地点
- 1
研究概览
简要总结
To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy in participants with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Has signed a written informed consent form (ICF) and is able to comply with the scheduled study visits and related procedures.
- •Age ≥ 18 years, irrespective of gender.
- •Confirmed diagnosis of locally advanced unresectable or metastatic solid tumor.
- •Expected survival ≥ 12 weeks.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or
- •Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to the first study drug administration.
- •Adequate bone marrow and organ function.
- •Additional Inclusion Criteria for Cohort 1:
- •Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.
- •Tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology specimens.
- •In the safety run-in phase, NSCLC participants who have received prior standard therapy.
- •In the cohort expansion phase, participants without driver gene mutations who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease.
- •Additional Inclusion Criteria for Cohort 2:
- •Histologically or cytologically confirmed unresectable locally advanced or metastatic non-squamous NSCLC.
- •In the safety run-in phase, participants should have received prior standard therapy.
- •In the cohort expansion phase:
- •Cohort 2A: NSCLC participants without driver gene mutations (including at least EGFR, ALK, and ROS1, with written documentation) who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease. Participants who received neoadjuvant/adjuvant therapy are eligible if disease recurrence or progression occurred >6 months after the last neoadjuvant/adjuvant therapy.
- •Cohort 2B: NSCLC participants with tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology specimens, who have experienced disease progression after prior EGFR-TKI therapy.
- •Additional Inclusion Criteria for Cohort 3
- •Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.
- •Tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology specimens.
- •In the safety run-in phase, participants should have experienced disease progression after prior EGFR-TKI therapy.
- •In the cohort expansion phase, NSCLC participants who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease. Participants who received neoadjuvant/adjuvant therapy are eligible if disease recurrence or progression occurred >6 months after the last neoadjuvant/adjuvant therapy.
排除标准
- •Participation in any other interventional clinical study, except for observational (non-interventional) studies or the follow-up period after the end of study treatment in an interventional study.
- •Prior treatment with antibody-drug conjugate (ADC) drugs bearing a camptothecin or its derivative (topoisomerase I inhibitor) small-molecule payload.
- •Prior to the first dose of study drug: a) Within 4 weeks: Received intravenous chemotherapy, macromolecular targeted therapy, antibody-drug conjugates, immunotherapy, endocrine therapy, cell therapy, intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy. b) Within 2 weeks or 5 half-lives (whichever is shorter): Received oral chemotherapy, small-molecule targeted therapy, or traditional Chinese herbal medicines indicated for anti-tumor treatment. c) Within 4 weeks: Received radical radiotherapy; within 2 weeks: Received palliative radiotherapy. d) Within 2 weeks or 5 half-lives (whichever is shorter): Received strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4). e) Within 4 weeks: Underwent major surgery (craniotomy, thoracotomy, laparotomy, or other surgeries deemed ""major"" by the investigator, excluding puncture biopsy), or has severe unhealed wounds, trauma, or ulcers; within 2 weeks: Underwent laparoscopic exploratory surgery. f) Within 4 weeks: Received live vaccine (mRNA and non-replicating adenovirus vaccines are not considered live vaccines).
- •Presence of adverse events from prior anti-tumor therapy that have not resolved to Grade 0 or 1 per NCI-CTCAE v5.0 [excluding Grade 2 alopecia, fatigue, pigmentation, insomnia, peripheral neuropathy, hypomagnesemia, and toxicities stably controlled by medication (e.g., hypothyroidism stably controlled by replacement therapy, hypertension with blood pressure stably controlled below 160/100 mmHg by antihypertensive medication)].
- •Additional Exclusion Criteria for Cohort 1:
- •History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.
- •History of significant toxicity associated with immune checkpoint inhibitor administration that required permanent discontinuation of such therapy.
- •Additional Exclusion Criteria for Cohort 2:
- •History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.
- •History of significant toxicity associated with immune checkpoint inhibitor administration that required permanent discontinuation of such therapy.
- •History of hemoptysis within 3 months prior to the first dose (blood volume >2.5 mL per cough or cumulative daily hemoptysis >10 mL), or current active bleeding.
- •Continuous use of aspirin (>325 mg/day) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function within 2 weeks prior to the first dose."
研究者
研究点 (1)
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