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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03936959




Registration number
NCT03936959
Ethics application status
Date submitted
26/04/2019
Date registered
3/05/2019

Titles & IDs
Public title
A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer
Scientific title
A Phase 1 Study of LY3434172, a Bispecific Antibody Monotherapy in Advanced Solid Tumors
Secondary ID [1] 0 0
J1E-MC-JZEA
Secondary ID [2] 0 0
17101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3434172

Experimental: LY3434172 - LY3434172 administered IV


Treatment: Drugs: LY3434172
Administered IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Baseline through Cycle 2 (Up to 42 Day Cycles)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172
Timepoint [1] 0 0
Predose Cycle 1 Day 1 through Cycle 4 Day 1 (Up to 42 Day Cycle)
Secondary outcome [2] 0 0
Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
Timepoint [2] 0 0
Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Secondary outcome [4] 0 0
Time to Response (TTR)
Timepoint [4] 0 0
Baseline to Date of CR or PR (Estimated up to 12 Months)
Secondary outcome [5] 0 0
Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
Timepoint [5] 0 0
Baseline through Measured Progressive Disease (Estimated up to 12 Months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/04/2021
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
France
State/province [3] 0 0
Toulouse cedex 9
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03936959