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

Advanced Cancer Clinical Trial

Official title:

A Phase 1 Study of LY3434172, a Bispecific Antibody Monotherapy in Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03936959
• Other study ID #: 17101
• Secondary ID: J1E-MC-JZEA2018-
• Status: Completed
• Phase: Phase 1
• Start date: May 24, 2019
• Est. completion date: April 29, 2021

Study information

• Verified date: June 15, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 29, 2021
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• LY3434172
Administered IV

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Sydney	New South Wales
Belgium	Universitair Ziekenhuis Gent	Gent
France	Institut Claudius Regaud - IUCT Oncopole	Toulouse cedex 9
Korea, Republic of	Asan Medical Center	Songpa-gu	Seoul
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Korea, Republic of, 

Outcome

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

External Links

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