Clinical Trials /

A Study of LY3435151 in Participants With Solid Tumors

NCT04099277

Description:

The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3435151 in Participants With Solid Tumors
  • Official Title: A Phase 1a/1b Study of LY3435151 Administered to Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 17364
  • SECONDARY ID: J1Q-MC-JZIA
  • NCT ID: NCT04099277

Conditions

  • Solid Tumor
  • Triple-negative Breast Cancer
  • Gastric Adenocarcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Cervical Carcinoma
  • High Grade Serous Ovarian Carcinoma
  • Hepatocellular Carcinoma
  • Undifferentiated Pleomorphic Sarcoma
  • Leiomyosarcoma

Interventions

DrugSynonymsArms
LY3435151LY3435151 Dose Escalation
PembrolizumabLY3435151 + Pembrolizumab Dose Escalation

Purpose

The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
LY3435151 Dose EscalationExperimentalLY3435151 administered intravenously (IV).
  • LY3435151
LY3435151 + Pembrolizumab Dose EscalationExperimentalLY3435151 and Pembrolizumab administered IV.
  • LY3435151
  • Pembrolizumab
LY3435151 Dose ExpansionExperimentalLY3435151 administered IV.
  • LY3435151
LY3435151 + Pembrolizumab Dose ExpansionExperimentalLY3435151 and Pembrolizumab administered IV.
  • LY3435151
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Participant must have certain types of cancer, which your study doctor will discuss
             with you

          -  Participant must have stopped other forms of treatment for cancer, which your study
             doctor will discuss with you

          -  Participant must be able and willing to provide a sample of your tumor before
             beginning treatment and once while on treatment. For certain tumor types, the outcome
             of the biopsy may exclude you from the study treatment (for Phase 1b)

          -  Participant must agree to use birth control

          -  Participant must have progressed through or are intolerant to therapies with known
             clinical benefit, which your study doctor will discuss with you

        Exclusion Criteria:

          -  Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled
             hepatitis B or C virus infection

          -  Participant must not have an autoimmune disease, which your study doctor will discuss
             with you

          -  Participant must not use corticosteroids, which your study doctor will discuss with
             you

          -  Participant must not have heart disease, Crohn's disease or brain cancer

          -  Participant must not be pregnant or breastfeeding
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with LY3435151 Dose-Limiting Toxicities (DLTs)
Time Frame:Baseline through Cycle 2 (21 Day Cycles)
Safety Issue:
Description:Number of Participants with LY3435151 DLTs

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles)
Safety Issue:
Description:PK: Cmax of LY3435151
Measure:PK: Cmax of LY3435151 in Combination with Pembrolizumab
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles)
Safety Issue:
Description:PK: Cmax of LY3435151 in Combination with Pembrolizumab
Measure:Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Time Frame:Baseline through Disease Progression or Death (Estimated up to 12 Months)
Safety Issue:
Description:ORR: Percentage of Participants with CR or PR
Measure:Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease
Time Frame:Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Safety Issue:
Description:DCR: Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease
Measure:Duration of Response (DoR)
Time Frame:Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 12 Months)
Safety Issue:
Description:DoR
Measure:Time to Response (TTR)
Time Frame:Baseline to Date of CR or PR (Estimated up to 12 Months)
Safety Issue:
Description:TTR
Measure:Progression Free Survival (PFS)
Time Frame:Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Safety Issue:
Description:PFS

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • immunotherapy
  • CD226 agonist

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