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EIK1001 · 3 trials · 4 indications
Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by BICR, or death due to any cause, whichever occurs first
OS defined as the time from the first dose of study medication to death due to any cause
Objective response (OR) is defined as participants who demonstrate complete response (CR) or partial response (PR) by RECIST 1.1 as assessed by the Investigator, adverse events (AEs), and discontinuation of study intervention due to an AE (Dose Optimization Only).
Progression-free survival (PFS) is defined as the time from the date of randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Objective Response (OR; defined as participants who demonstrate confirmed complete response \[CR\] or partial response \[PR\] by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1 as assessed by the Investigator) (Dose Optimization Only).
Adverse events (AEs), and discontinuation of study treatment due to an AE (Dose Optimization Only). An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity.
| Arm | Type | Description |
|---|---|---|
| Arm 1 (Placebo in Combination with SOC) | PLACEBO_COMPARATOR | Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC). |
| Arm 2 (EIK1001 in Combination with SOC) | EXPERIMENTAL | Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC). |
| Arm 3 (EIK1001 in Combination with SOC) | EXPERIMENTAL | Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC). |
| Arm 1 | ACTIVE_COMPARATOR | Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab). |
| Arm 2 | EXPERIMENTAL | Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab). |
| Arm 3 | EXPERIMENTAL | Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab). |
| Cohort A - Participants with non-squamous NSCLC | EXPERIMENTAL | Participants in this arm will receive EIK1001 + Standard of Care (SOC). |
| Cohort B - Participants with squamous NSCLC | EXPERIMENTAL | Participants in this arm will receive EIK1001 + Standard of Care (SOC). |
| Name | Type | Description |
|---|---|---|
| EIK1001 | DRUG | EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist |
| Pembrolizumab (KEYTRUDA®) | DRUG | PD-1 inhibitor |
| Placebo | DRUG | Placebo control |
| Paclitaxel + Carboplatin | DRUG | SOC Chemotherapy for squamous NSCLC |
| Nab-paclitaxel + Carboplatin | DRUG | SOC Chemotherapy for squamous NSCLC |
| Pemetrexed + Cisplatin /Carboplatin | DRUG | SOC Chemotherapy for non-squamous NSCLC |
| Pembrolizumab (KEYTRUDA® ) | DRUG | Pembrolizumab is a PD-1 inhibitor. |
| Pembrolizumab | DRUG | PD-1 inhibitor |
| Paclitaxel | DRUG | Chemotherapy |
| Pemetrexed | DRUG | Chemotherapy |
| Carboplatin | DRUG | Chemotherapy |
Key Inclusion Criteria: 1. Participant must be ≥ 18 years old at the time of signing the informed consent. 2. Participant has a life expectancy of at least 3 months. 3. Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered ...
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EIK1001 is an investigational small molecule oncology drug developed by Eikon Therapeutics, Inc. It is being studied in Phase 2 clinical trials as a combination therapy for advanced melanoma and stage 4 non-small cell lung cancer, including both squamous and non-squamous histologies. It is designed to act on Toll-like receptors 7 and 8.
EIK1001 targets TLR7 and TLR8, two Toll-like receptors. TLR7 and TLR8 are pattern recognition receptors involved in innate immune sensing. By acting on these Toll-like receptor targets, EIK1001 is being developed as an immune-modulating agent and is studied in combination with the checkpoint inhibitor pembrolizumab, with or without chemotherapy.
EIK1001 is being developed by Eikon Therapeutics, Inc., which trades under the ticker EIKN. Eikon Therapeutics is the sponsor behind the Phase 2 program testing EIK1001 in advanced melanoma and stage 4 non-small cell lung cancer, including combinations with pembrolizumab and chemotherapy.
EIK1001 is in Phase 2 clinical development. It is investigational and is being evaluated in recruiting and active Phase 2 studies in advanced melanoma and stage 4 non-small cell lung cancer. The melanoma study is randomized, double-blind, and active-controlled, comparing EIK1001 plus pembrolizumab against placebo plus pembrolizumab.
EIK1001 is being studied in three Phase 2 trials. NCT07365319 tests EIK1001 with pembrolizumab and chemotherapy in stage 4 NSCLC and is recruiting across the United States, Europe, Australia, South Korea, and South Africa. NCT06697301 compares EIK1001 plus pembrolizumab with placebo plus pembrolizumab in advanced melanoma. NCT06246110 is an active, not recruiting NSCLC study in the United States.
EIK1001 is being studied as a first-line combination therapy for advanced melanoma. In trial NCT06697301, it is given with pembrolizumab and compared against placebo plus pembrolizumab in a randomized, double-blind design. The study is recruiting adults aged 18 and older across sites in North America, Europe, Israel, Australia, New Zealand, South Africa, and South Korea.