NCT06120075进行中（未招募）1 期
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
- 试验地点
- 19
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The primary purpose of this study is to assess the safety and tolerability of AB801 in participants with advanced malignancies, and to determine a recommended AB801 dose for expansion.
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
- •Monotherapy-specific criteria for dose escalation cohorts:
- •Participants may have cytologically or pathologically confirmed non-small cell lung carcinoma (NSCLC), colorectal carcinoma (CRC), breast, ovarian, renal cell carcinoma (RCC), head and neck squamous cell carcinoma (HNSCC), or bladder (including urothelial malignancies of the renal pelvis and ureter) carcinoma that has progressed or was non-responsive to available therapies with no standard of care (SOC) options, or for whom standard therapy has proven ineffective, intolerable, or considered inappropriate; or for whom a clinical study of an investigational agent is a recognized SOC.
- •Disease-specific criteria for dose-expansion (NSCLC):
- •Cytologically or pathologically confirmed locally advanced unresectable or metastatic (Stage IIIB-IV per American Joint Committee on Cancer version 8) non-squamous NSCLC negative for actionable mutations in EGFR, ALK, ROS1, NTRK, C-MET, or RET. Mixed SCLC and squamous NSCLC histology is not permitted.
- •Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and PD-(L)-1inhibitor.
- •Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance (Version 1.1) (Section 1.1). The measurable lesion must be outside of a radiation field if the participant received prior radiation unless discussed and approved by the study physician.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
排除标准
- •Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product.
- •Underlying medical conditions or adverse events that, in the physician or sponsor's opinion, will make the administration of investigational products hazardous.
- •Prolonged QT interval defined as mean corrected QT interval (QTc) ≥ 450 milliseconds (ms).
- •Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment.
- •Treatment with systemic immunosuppressive medication (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Dose Escalation Cohort 4 - AB801 capsule Dose Level 4
Experimental
Participants will receive AB801 orally daily
干预措施: AB801 (Drug)
Dose Expansion Cohort - AB801 + Docetaxel
Experimental
Participants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion
干预措施: Docetaxel (Drug)
Dose Escalation Cohort 1 - AB801 capsule Dose Level 1
Experimental
Participants will receive AB801 orally daily
干预措施: AB801 (Drug)
Dose Escalation Cohort 3 - AB801 capsule Dose Level 3
Experimental
Participants will receive AB801 orally daily
干预措施: AB801 (Drug)
Dose Escalation Cohort 2 - AB801 capsule Dose Level 2
Experimental
Participants will receive AB801 orally daily
干预措施: AB801 (Drug)
Dose Escalation Cohort 5 - AB801 tablets Dose Level 5
Experimental
Participants will receive AB801 orally daily
干预措施: AB801 (Drug)
Dose Escalation Cohort 6 - AB801 tablets Dose Level 6
Experimental
Participants will receive AB801 orally daily
干预措施: AB801 (Drug)
Dose Escalation Cohort 7 - AB801 tablets Dose Level 7
Experimental
Participants will receive AB801 orally daily
干预措施: AB801 (Drug)
Dose Expansion Cohort - AB801 + Docetaxel
Experimental
Participants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion
干预措施: AB801 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Up to 2 years
Dose Escalation Cohorts: Number of Participants With Dose-Limiting Toxicities (DLTs)
时间窗: Up to 2 years
次要结局
- Area Under the Plasma Drug Concentration-Time Curve (AUC)(Predose, Up to 8 hours postdose)
- Maximum Concentration (Cmax) in Plasma(Predose, Up to 8 hours postdose)
- Objective response rate (ORR) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Up to 2 years)
- Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1(Up to 2 years)
- Time to Maximum Concentration (Tmax) in Plasma(Predose, Up to 8 hours postdose)
研究者
研究点 (19)
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