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A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer

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Status and phase

Completed
Phase 1

Conditions

Advanced Cancer

Treatments

Drug: LY3475070
Drug: Pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04148937
17504
Keynote A57 (Other Identifier)
2019-003270-64 (EudraCT Number)
J2I-MC-JZMA (Other Identifier)

Details and patient eligibility

About

The reason for this study is to see if the CD73 inhibitor LY3475070 alone or in combination with pembrolizumab is safe and effective in participants with advanced cancer.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must have certain types of cancer such as breast cancer, pancreatic cancer, lung cancer, kidney cancer, skin cancer (melanoma), prostate cancer, and ovarian cancer
  • Participants must have stopped other forms of treatment for the cancer
  • In the expansion cohorts participants must be able and willing to provide a sample of the tumor before beginning treatment and a sample during the treatment. For certain tumor types, the result of a test on the tumor sample may exclude the participant from the study
  • Participants must not be pregnant, and must agree to use birth control
  • Participants must have progressed through or be intolerant to therapies with known clinical benefit

Exclusion criteria

  • Participants must not have a current untreated tuberculosis, lung disease, heart disease, uncontrolled HIV, autoimmune disease, active hepatitis B or C virus infection or using corticosteroids
  • Participant must not have cancer that has spread to the brain
  • Participant must not have received a vaccine within the last 30 days
  • Participant must not have had bowel obstruction within the last 6 months, or intestinal surgery
  • Participant must not have an infection that is currently being treated

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 7 patient groups

Phase 1a Cohort A LY3475070 (dose escalation)
Experimental group
Description:
Participants received 150 milligram (mg) once daily or 300 mg once daily or 300mg twice daily or 600mg once daily oral LY3475070 on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
Treatment:
Drug: LY3475070
Phase 1a Cohort B LY3475070 + Pembrolizumab (dose escalation)
Experimental group
Description:
Participants received 150 mg once daily or 150 mg twice daily or 300 mg once daily or 300mg twice daily oral LY3475070 on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
Treatment:
Drug: LY3475070
Drug: Pembrolizumab
Phase 1b Cohort C1 LY3475070 + Pembrolizumab (dose expansion)
Experimental group
Description:
LY3475070 administered orally and pembrolizumab administered IV. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.
Treatment:
Drug: LY3475070
Drug: Pembrolizumab
Phase 1b Cohort C2 LY3475070 (dose expansion)
Experimental group
Description:
LY3475070 administered orally. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.
Treatment:
Drug: LY3475070
Phase 1b Cohort D1 LY3475070 + Pembrolizumab (dose expansion)
Experimental group
Description:
LY3475070 administered orally and pembrolizumab administered IV. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.
Treatment:
Drug: LY3475070
Drug: Pembrolizumab
Phase 1b Cohort D2 LY3475070 (dose expansion)
Experimental group
Description:
LY3475070 administered orally. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.
Treatment:
Drug: LY3475070
Phase 1b Cohort E LY3475070 + Pembrolizumab (dose expansion)
Experimental group
Description:
LY3475070 administered orally and pembrolizumab administered IV. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.
Treatment:
Drug: LY3475070
Drug: Pembrolizumab

Trial documents
2

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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