NCT05359445进行中（未招募）1 期
A Phase Ia/Ib First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-Tumor Activity of IMA401, a Bispecific T Cell Engaging Receptor Molecule (TCER®), as Monotherapy or in Combination With Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 95
- 试验地点
- 44
- 主要终点
- Number of patients with dose limiting toxicities
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors.
Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed.
Primary objective:
- To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab
Secondary objectives:
- To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab
- To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab
- To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab
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
- •Patients must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures
- •Patients ≥ 18 years old
- •Patients must have pathologically confirmed and documented advanced and/or metastatic NSCLC or HNSCC, other solid tumor may be considered
- •Confirmed HLA status and IMA401 tumor target MAGE-A4 and/or MAGE-A8 expression
- •Life expectancy > 2 months
- •ECOG Performance Status of 0 to 1
- •Measurable disease according to RECIST 1.1
- •Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status
- •Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments
- •The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the IMA401 therapy
排除标准
- •Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)
- •History of hypersensitivity to components of IMA401, CPI treatment or rescue medications, contraindication for pembrolizumab
- •Patients with prior allogeneic stem cell transplantation or organ transplantation
- •Patients with autoimmune diseases needing disease-directed treatment
- •Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results
- •Positive for HIV or with active hepatitis B or C infection.
- •Patients with active infection
- •Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting trial treatment
- •Patients with active central nervous system metastases and leptomeningeal metastases
研究组 & 干预措施
Dose-Finding IMA401 TCER® Monotherapy (Phase Ia)
Experimental
Dose-Finding Escalation/De-escalation with IMA401 TCER® (Phase Ia)
干预措施: IMA401 (Phase Ia) (Biological)
Dose-Finding Combination Therapy with IMA401 TCER® and Pembrolizumab (Phase Ia)
Experimental
Dose-Finding Escalation/De-escalation of combination therapy with IMA401 TCER and pembrolizumab (Phase Ia)
干预措施: IMA401 (Phase Ia) (Biological)
Dose-Finding Combination Therapy with IMA401 TCER® and Pembrolizumab (Phase Ia)
Experimental
Dose-Finding Escalation/De-escalation of combination therapy with IMA401 TCER and pembrolizumab (Phase Ia)
干预措施: Pembrolizumab (Phase Ia) (Biological)
Extension IMA401 TCER® Monotherapy (Phase Ib)
Experimental
IMA401 monotherapy extension cohort following the determination of the recommended dose for extension (RDE) (Phase Ib)
干预措施: IMA 401 (Phase Ib) (Biological)
结局指标
主要结局
Number of patients with dose limiting toxicities
时间窗: 44 months
次要结局
- Number of patients with treatment-emergent adverse events (TEAEs)(93 months)
- Number of patients with serious TEAEs(93 months)
- Number of patients with treatment emergent adverse events of special interest (AESIs)(93 months)
- Frequency of dose interruptions and reductions(93 months)
- Duration of dose interruptions and reductions(93 months)
- Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using RECIST v1.1 and iRECIST(93 months)
- Disease control rate (DCR) of CR, PR or stable disease (SD) lasting 6 or more weeks following the initiation of IMA401(93 months)
- Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST(93 months)
- Progression-free survival (PFS) based on RECIST v1.1 and iRECIST(93 months)
- Overall survival (OS)(93 months)
- Determination of IMA 401 PK parameter: time at Cmax (Tmax)(44 months)
- Determination of IMA 401 PK parameter: maximal serum concentration (Cmax)(44 months)
- Determination of IMA 401 PK parameter: minimal serum concentration (Cmin)(44 months)
- Determination of IMA 401 PK parameter: area under the serum concentration-time curve (AUC)(44 months)
- Determination of IMA 401 PK parameter: clearance (Cl)(44 months)
- Determination of IMA 401 PK parameter: half-life (t1/2)(44 months)
- Determination of IMA 401 PK parameter: volume of distribution (Vss)(44 months)
- Determination of IMA 401 PK parameter: assessment of dose-proportionality(44 months)
- Determination of IMA 401 PK parameter: steady-state attainment(44 months)
研究者
研究点 (44)
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