A Multicenter, Multi-Part, Phase I/II 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
Study Identifier:
EIK1005-002
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in treating patients with advanced cancer.
Main objective (English)
1. 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). 2. To evaluate the safety and tolerability of EIK1005 for dose optimization (Part 2).
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Gastric
Solid Tumor
Endometrial
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- 1. is ≥ 18 years of age at the time of signing the informed consent. 2. has a life expectancy of at least 3 months. 3. has histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor. Part 1A: recommend that participants have archival tissue not more than 3 years old. Part 1B and Part 2: participant has locally confirmed Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (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. 4. 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 checkpoint inhibitor (CPI) therapy and (2) participants with microsatellite stable cells (MSS) cancers that have progressed following at least one regimen of platinum, alkylating or topoisomerase containing chemotherapy. 5. has measurable disease at baseline according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the PI. 6. has an Eastern Cooperative Oncology Group (ECOG) score of 0 to 1. 7. has an adequate organ and marrow function. Key
- as per CTIS:
- Participants are eligible to be included in the study only if all of the following criteria apply, and the participant: 1. is ≥ 18 years of age at the time of signing the informed consent.
- 2. has a life expectancy of at least 3 months.
- 3. 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.
- 4. 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.
- 5. has measurable disease at baseline according to RECIST 1.1 as determined by the PI
- 6. has an ECOG score of 0 to 1.
- 7. has an adequate organ and marrow function.
Exclusion criteria
- 1. has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy-induced adverse events (AEs). 2. has received prior treatment with Werner (WRN) inhibitor. 3. 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. 4. In Parts 1B and Part 2 Rescue: 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. 5. has known additional malignancy that is progressing or has required active treatment within the past 3 years. 6. has known active central nervous system (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. 7. has mean resting QTcF > 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs). 8. 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). 9. has history of (non-infectious) pneumonitis/pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease. 10. has active tuberculosis. 11. has any active infections requiring systemic therapy.
- As per CTIS:
- A participant is excluded from the study if any of the following criteria apply: 1. has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy induced AEs.
- 2. has received prior treatment with WRN inhibitor.
- 3. 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.
- 4. 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.
- 5. has known additional malignancy that is progressing or has required active treatment within the past 3 years.
- 6. 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
- 7. has mean resting QTcF > 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs).
- 8. 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).
- 9. has history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
- 10. has active tuberculosis.
- 11. has any active infections requiring systemic therapy
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Henry Xiong
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Gastric
Solid Tumor
Endometrial
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Will Be Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Gastric
Solid Tumor
Endometrial