2026-525248-13-00招募中2 期
A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Checkpoint Inhibitor Naïve Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 81
- 试验地点
- 74
- 主要终点
- 1. DLTs & AEs
研究概览
简要总结
-
To evaluate the safety and tolerability of EIK1005 as monotherapy or in combination with pembrolizumab to determine the MTD (or MAD) of EIK1005 (Part 1).
-
To evaluate the safety and tolerability of EIK1005 for dose optimization (Part 2).
研究设计
- 分配方式
- Randomized
- 主要目的
- Part 2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply, and the participant:
- •is ≥ 18 years of age at the time of signing the informed consent.
- •has a life expectancy of at least 3 months.
- •has histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor. a. Part 1A: recommend that participants have archival tissue not more than 3 years old. b. Part 1B and Part 2: participant has locally confirmed MSI-H or dMMR tumor. Participant must have archival tumor tissue (not more than 3 years old) for retrospective confirmation of MSI-H or dMMR tumor by a central laboratory.
- •In Part 1A, has received and then progressed after or is intolerant to at least 1 standard treatment regimen in the advanced setting. The participant does not have alternative therapeutic options per PI’s medical judgement. Preference should be given to: (1) participants with MSI-H or dMMR cancers that have progressed after CPI therapy and (2) participants with MSS cancers that have progressed following at least one regimen of platinum, alkylating or topoisomerase containing chemotherapy.
- •has measurable disease at baseline according to RECIST 1.1 as determined by the PI
- •has an ECOG score of 0 to
- •has an adequate organ and marrow function.
排除标准
- •A participant is excluded from the study if any of the following criteria apply:
- •has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy induced AEs.
- •has active tuberculosis.
- •has any active infections requiring systemic therapy
- •has received prior treatment with WRN inhibitor.
- •has a history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients, history of serious allergic reactions leading to hospitalization, or any other allergic reaction in general.
- •In Parts 1B: diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- •has known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study treatment
- •has mean resting QTcF > 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs).
- •has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Participants may enroll with the following conditions: Type 1 diabetes, hypothyroidism requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia not requiring systemic treatment).
- •has history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
研究组 & 干预措施
PEMBROLIZUMAB
Test
干预措施: PEMBROLIZUMAB (Drug)
EIK1005 10mg Tablets, EIK1005 50mg Tablets, EIK1005 200mg Tablets
Test
干预措施: EIK1005 50mg Tablets (Drug)
EIK1005 10mg Tablets, EIK1005 50mg Tablets, EIK1005 200mg Tablets
Test
干预措施: EIK1005 10mg Tablets (Drug)
EIK1005 10mg Tablets, EIK1005 50mg Tablets, EIK1005 200mg Tablets
Test
干预措施: EIK1005 200mg Tablets (Drug)
PEMBROLIZUMAB
Test
干预措施: PEMBROLIZUMAB (Drug)
结局指标
主要结局
1. DLTs & AEs
1. DLTs & AEs
2. AEs
2. AEs
次要结局
- 1. OR (defined as participants who have a CR or PR) by RECIST 1.1 as assessed by the Investigator.
- 2. DOR (defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR) by RECIST 1.1 as assessed by the Investigator.
- 3. DC (defined as participants with a BOR of CR, PR, or SD) by RECIST 1.1 as assessed by the Investigator.
- 4. OR
- 5. DOR
- 6. DC
- 7. PFS (defined as the time from randomization to the first documented disease progression by RECIST 1.1 as assessed by the Investigator or death due to any cause, whichever occurs first).
- 8. PK parameters derived from plasma concentrations of EIK1005, following multiple doses, including but not limited to: • AUC0-24, AUCtau,ss, Cmax, t1/2, tmax, Rac-Cmax, RacAUC
研究者
Nilou Mobashery
Scientific
Eikon Therapeutics Inc.
研究点 (74)
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