Active not recruiting

A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors

I9A-MC-JLDA - ClinicalTrials.gov - NCT03099109

The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.
How long will I be in the trial?
Your participation could last up to 12 months depending on how you and your tumor respond
Email
Active not recruiting

A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors

I9A-MC-JLDA - ClinicalTrials.gov - NCT03099109

The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.
How long will I be in the trial?
Your participation could last up to 12 months depending on how you and your tumor respond
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participant must have an advanced solid tumor confirmed by histology or cytology - Phase 1a participant must submit an archived tumor tissue sample (if available) - Phase 1b participant must be willing to provide a new or recently obtained biopsy

Participant must have an estimated life expectancy of 12 weeks

Participants must NOT

Participant must not have symptoms of uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease that requires treatment occurring at the same time as the study treatment

Participant must not have received a live vaccine within 30 days before the first dose of study treatment - Female participant must not be pregnant, breastfeeding, or planning to become pregnant

Participant must not have active or chronic HIV, active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment

Participant must not have a bowel obstruction

Trial Summary

Conditions the trial is for

Solid Tumor

What the trial is testing?

LY3321367, LY3300054

Could I receive a Placebo?

no

Enrollment Goal

275

Trial Dates

April 2017 - December 2021

Trial Phase

1

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participant must have an advanced solid tumor confirmed by histology or cytology - Phase 1a participant must submit an archived tumor tissue sample (if available) - Phase 1b participant must be willing to provide a new or recently obtained biopsy

Participant must have an estimated life expectancy of 12 weeks

Participants must NOT

Participant must not have symptoms of uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease that requires treatment occurring at the same time as the study treatment

Participant must not have received a live vaccine within 30 days before the first dose of study treatment - Female participant must not be pregnant, breastfeeding, or planning to become pregnant

Participant must not have active or chronic HIV, active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment

Participant must not have a bowel obstruction

Trial Summary

Conditions the trial is for

Solid Tumor

What the trial is testing?

LY3321367, LY3300054

Could I receive a Placebo?

no

Enrollment Goal

275

Trial Dates

April 2017 - December 2021

Trial Phase

1

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Trial Locations

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Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?