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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

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

Clinicaltrials.gov identifier NCT03936959

Recruitment Status Active, not recruiting

First Posted May 3, 2019

Last update posted August 19, 2020

Study Description

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.

  • Condition or Disease:Advanced Cancer
  • Intervention/Treatment: Drug: LY3434172
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 1 Study of LY3434172, a Bispecific Antibody Monotherapy in Advanced Solid Tumors
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: March 2020
  • Actual Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
Experimental: LY3434172
LY3434172 administered IV
Drug: LY3434172
Administered IV
Outcome Measures
  • Primary Outcome Measures: 1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 2 (Up to 42 Day Cycles) ]
    Number of participants with DLTs
  • Secondary Outcome Measures: 1. Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172 [ Time Frame: Predose Cycle 1 Day 1 through Cycle 4 Day 1 (Up to 42 Day Cycle) ]
    PK: Cmin of LY3434172
  • 2. Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months) ]
    ORR: Percentage of participants with a CR or PR
  • 3. Duration of Response (DOR) [ Time Frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) ]
    DOR
  • 4. Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 12 Months) ]
    TTR
  • 5. Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months) ]
    DCR: Percentage of participants who exhibit SD, CR or PR
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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).

Contacts and Locations
Contacts
Locations

United States, Texas
University of Texas MD Anderson Cancer Center
Houston

Australia, New South Wales
St Vincent's Hospital
Sydney

Belgium
Universitair Ziekenhuis Gent
Gent

France
Institut Claudius Regaud - IUCT Oncopole
Toulouse cedex 9

Korea, Republic of, Seoul
Asan Medical Center
Songpa-gu

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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) Eli Lilly and Company

More Information
  • Responsible Party: Eli Lilly and Company
  • ClinicalTrials.gov Identifier: NCT03936959 History of Changes
  • Other Study ID Numbers: 17101, J1E-MC-JZEA, 2018-003871-37
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: August 19, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Eli Lilly and Company: PD-1 PD-L1
  • Additional relevant MeSH terms: Neoplasms