A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer

NCT ID: NCT03936959

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2021-04-29

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1/PD-L1 bispecific antibody, in participants with advanced solid tumors.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3 Milligram (mg) - 10 mg LY3434172

3 mg LY3434172 administered intravenously (IV) on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle.

Participants continued to receive study treatment until they met a criterion for discontinuation.

Group Type: EXPERIMENTAL

LY3434172

Intervention Type: DRUG

Administered IV

30 mg LY3434172

30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.

Group Type: EXPERIMENTAL

LY3434172

Intervention Type: DRUG

Administered IV

100 mg LY3434172

100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.

Group Type: EXPERIMENTAL

LY3434172

Intervention Type: DRUG

Administered IV

Interventions

LY3434172

Administered IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must have histological or cytological evidence of a diagnosis of cancer that is not amenable/resistant to approved standard-of-care therapy for the following solid tumors: Melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial cancer, gastric cancer, colorectal cancer, biliary tract cancer, anal cancer, nasopharyngeal cancer, esophageal cancer, SCLC, ovarian cancer, mesothelioma, pan-tumor MSIhi solid tumors, hepatocellular carcinoma, merkel cell cancer, cutaneous squamous cell carcinoma, endometrial cancer, breast cancer, cervical cancer, thyroid cancer, salivary cancer, and prostate cancer who have received at least one line of standard systemic therapy for their respective tumor type in the metastatic setting with progressive locally advanced or metastatic disease. Prior anti-programmed death 1 (PD-1) and anti-programmed death ligand 1 (PD-L1) allowed if they received another therapy immediately prior to this study or there has been a lapse of approximately ≥90 days from prior therapy.
• Must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies.
• Have at least one measurable lesion assessable as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Have adequate organ function.
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Have an estimated life expectancy of 12 weeks, in the judgment of the investigator.

Exclusion Criteria

• Have symptomatic central nervous system (CNS) malignancy or metastasis not requiring concurrent treatment, including but not limited to surgery, radiation, corticosteroids and/or anticonvulsants to treat CNS metastases, and their disease is asymptomatic and radiographically stable for at least 30 days.
• Have moderate or severe cardiovascular disease.
• Have active or suspected autoimmune disease (eg. autoimmune vasculitis, autoimmune myocarditis, among others).
• Have serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including known infection with human immunodeficiency virus (HIV) unless they are well controlled on highly active antiretroviral therapy (HAART) therapy with no evidence of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections within the last 2 years, and CD4 T-cells count > 350 cells/µl , active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment.

• Use of escalating or chronic supraphysiologic doses of corticosteroids or immunosuppressive agents (such as, exceeding 10 milligrams/day of prednisone or equivalent). Use of topical, ophthalmic, inhaled, and intranasal corticosteroids permitted.
• Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.
• Evidence of interstitial lung disease or noninfectious pneumonitis (active or treated by corticosteroid therapy).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

St Vincent's Hospital

Sydney, New South Wales, Australia

Universitair Ziekenhuis Gent

Ghent, , Belgium

Institut Claudius Regaud - IUCT Oncopole

Toulouse, , France

Asan Medical Center

Songpa-gu, Seoul, South Korea

Countries

United States; Australia; Belgium; France; South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/1aYuXmPG4pbGQPqjXu8y8C

A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer

Other Identifiers

J1E-MC-JZEA

Identifier Type: OTHER

Identifier Source: secondary_id

2018-003871-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17101

Identifier Type: -

Identifier Source: org_study_id