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

Conditions

Advanced Solid Tumors

Brief summary

1. DLTs & AEs, 2. AEs

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGEIK1005 10mg Tablets

DRUGEIK1005 50mg Tablets

DRUGPEMBROLIZUMAB

DRUGEIK1005 200mg Tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. DLTs & AEs, 2. AEs	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Outcome results

None listed