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TerminatedNCT03936959Updated Jan 15, 2025Results posted

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

A Phase 1 interventional study of LY3434172 in Advanced Cancer, sponsored by Eli Lilly and Company. Terminated at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Why this study was terminated
Study did not achieve its primary objective due to early termination of the study
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Cancer

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Keywords

  • PD-1
  • PD-L1
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 139 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    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.

    Drug: LY3434172

  • Experimental
    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.

    Drug: LY3434172

  • Experimental
    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.

    Drug: LY3434172

Interventions

  • DrugLY3434172

    Administered IV

06

What researchers measure

Primary outcomes

  1. Number of Participants With Dose Limiting Toxicities (DLTs)

    A DLT is defined as adverse event/s of grade 3 or higher that occurs during the DLT observation period, which is Cycle 1 of each dose escalation cohort, and is clinically significant and definitely, probably, or possibly related to LY3434172, in the opinion of the investigator.

    Time frame: Baseline through Cycle 1 (Up to 42 Day Cycle)

Secondary outcomes

  1. Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172

    PK: Cmin of LY3434172

    Time frame: PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; Cycle 1 Day 15 (C1D15): Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion

  2. PK: Maximum Concentration (Cmax) of LY3434172

    PK: Cmax of LY3434172

    Time frame: PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion

  3. PK: Area Under the Curve From Zero to Time to Last Measurable Concentration (AUC0-tlast) of LY3434172

    PK: AUC 0-tlast of LY3434172

    Time frame: PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion

  4. Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)

    ORR: Percentage of participants who have received any amount of study drug, have at least one postbaseline tumor image, and achieved a best overall response (BOR) of confirmed Complete Response (CR) is defined a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Time frame: Baseline through Measured Progressive Disease (Up to 8.4 Months)

  5. Duration of Response (DOR)

    DOR is defined only for responders (participants with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of the first observed radiographically documented progressive disease (PD), or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment.

    Time frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 8.4 Months)

  6. Time to Response (TTR)

    TTR is defined as the time from the date of first study treatment until the first evidence of confirmed CR or PR.

    Time frame: Baseline to Date of CR or PR (Up to 8.4 Months)

  7. Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), CR or PR

    Disease control rate is defined as the number of participants with SD, confirmed PR, or confirmed CR (CR+PR+SD) divided by the number of enrolled participants who have received any quantity of study treatment.

    Time frame: Baseline through Measured Progressive Disease (Up to 8.4 Months)

07

Results

Posted Jan 15, 2025
Limitations and caveats
Study terminated by sponsor.

Participant flow

Participant flow — Overall Study
Milestone3 Milligram (mg) - 10 mg LY343417230 mg LY3434172100 mg LY3434172
Started343
Received at least one dose of study drug343
Completed343
Not completed000

Outcome measures

PrimaryNumber of Participants With Dose Limiting Toxicities (DLTs)

A DLT is defined as adverse event/s of grade 3 or higher that occurs during the DLT observation period, which is Cycle 1 of each dose escalation cohort, and is clinically significant and definitely, probably, or possibly related to LY3434172, in the opinion of the investigator.

Time frame:
Baseline through Cycle 1 (Up to 42 Day Cycle)
Reported as:
Count of participants · Participants
Number of Participants With Dose Limiting Toxicities (DLTs)
Participants3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172
Number of Participants With Dose Limiting Toxicities (DLTs)000
SecondaryPharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172

PK: Cmin of LY3434172

Time frame:
PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; Cycle 1 Day 15 (C1D15): Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion
Reported as:
Geometric mean · nanogram per milliliter (ng/mL)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172
nanogram per milliliter (ng/mL)3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172
Cycle 1 Day 1NA ± NA775 ± 1074150 ± 254
Cycle 1 Day 15NA ± NA1017 ± 635600 ± 85
SecondaryPK: Maximum Concentration (Cmax) of LY3434172

PK: Cmax of LY3434172

Time frame:
PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion
Reported as:
Geometric mean · ng/mL
PK: Maximum Concentration (Cmax) of LY3434172
ng/mL3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172
Cycle 1 Day 1734 ± 19.18250 ± 17.722700 ± 60.8
Cycle 1 Day 15NA ± NA18600 ± 52.943000 ± 58.5
SecondaryPK: Area Under the Curve From Zero to Time to Last Measurable Concentration (AUC0-tlast) of LY3434172

PK: AUC 0-tlast of LY3434172

Time frame:
PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion
Reported as:
Geometric mean · hour*nanogram per milliliter (hr*ng/mL)
PK: Area Under the Curve From Zero to Time to Last Measurable Concentration (AUC0-tlast) of LY3434172
hour*nanogram per milliliter (hr*ng/mL)3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172
C1D17280 ± 51.0584000 ± 31.51900000 ± 121
C1D15NA ± NA559000 ± 2393010000 ± 19.9
SecondaryObjective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)

ORR: Percentage of participants who have received any amount of study drug, have at least one postbaseline tumor image, and achieved a best overall response (BOR) of confirmed Complete Response (CR) is defined a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame:
Baseline through Measured Progressive Disease (Up to 8.4 Months)
Reported as:
Number · Percentage of participants
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Percentage of participants3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172
Complete Response000
Partial Response0033.3
SecondaryDuration of Response (DOR)

DOR is defined only for responders (participants with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of the first observed radiographically documented progressive disease (PD), or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment.

Time frame:
Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 8.4 Months)
Reported as:
Median · Months
Duration of Response (DOR)
Months3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172
Duration of Response (DOR)——NA (NA to NA)
SecondaryTime to Response (TTR)

TTR is defined as the time from the date of first study treatment until the first evidence of confirmed CR or PR.

Time frame:
Baseline to Date of CR or PR (Up to 8.4 Months)
Reported as:
Median · Months
Time to Response (TTR)
Months3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172
Time to Response (TTR)——NA (NA to NA)
SecondaryDisease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), CR or PR

Disease control rate is defined as the number of participants with SD, confirmed PR, or confirmed CR (CR+PR+SD) divided by the number of enrolled participants who have received any quantity of study treatment.

Time frame:
Baseline through Measured Progressive Disease (Up to 8.4 Months)
Reported as:
Number · percentage of participants
Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), CR or PR
percentage of participants3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172
Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), CR or PR66.725.066.7

Adverse events

Collected over Baseline Up to 16.7 Months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
3 mg -10 mg LY34341720/3 (0%)1/3 (33.3%)3/3 (100%)
30 mg LY34341721/4 (25%)1/4 (25%)4/4 (100%)
100 mg LY34341722/3 (66.7%)1/3 (33.3%)3/3 (100%)
Most frequent serious events
Most frequent serious events
Event3 mg -10 mg LY343417230 mg LY3434172100 mg LY3434172
Acute respiratory failureRespiratory, thoracic and mediastinal disorders1/30/40/3
DyspnoeaRespiratory, thoracic and mediastinal disorders1/30/40/3
PneumothoraxRespiratory, thoracic and mediastinal disorders0/30/41/3
Small intestinal obstructionGastrointestinal disorders0/31/40/3
Most frequent other events
Showing 10 of 33
Most frequent other events
Event3 mg -10 mg LY343417230 mg LY3434172100 mg LY3434172
NauseaGastrointestinal disorders0/33/41/3
FatigueGeneral disorders0/32/42/3
Oedema peripheralGeneral disorders2/32/40/3
ConstipationGastrointestinal disorders0/32/40/3
VomitingGastrointestinal disorders0/32/40/3
PalpitationsCardiac disorders0/30/41/3
Abdominal painGastrointestinal disorders1/31/40/3
DiarrhoeaGastrointestinal disorders0/30/41/3
PyrexiaGeneral disorders0/31/41/3
CellulitisInfections and infestations1/30/40/3

Baseline characteristics

All participants who received any quantity of LY3434172, regardless of their eligibility for the study.

Age, Categorical
Age, Categorical(Participants)3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172Total
<=18 years0000
Between 18 and 65 years1315
>=65 years2125
Sex: Female, Male
Sex: Female, Male(Participants)3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172Total
Female2316
Male1124
Race (NIH/OMB)
Race (NIH/OMB)(Participants)3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172Total
American Indian or Alaska Native0000
Asian0022
Native Hawaiian or Other Pacific Islander0000
Black or African American0101
White2316
More than one race0000
Unknown or Not Reported1001
Region of Enrollment
Region of Enrollment(Participants)3 mg - 10 mg LY343417230 mg LY3434172100 mg LY3434172Total
South Korea0011
Belgium1113
United States2305
Australia0011
08

Study locations

5 sites
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • St Vincent's Hospital
    Sydney, New South Wales 2010, Australia
  • Universitair Ziekenhuis Gent
    Gent, 9000, Belgium
  • Institut Claudius Regaud - IUCT Oncopole
    Toulouse cedex 9, 31059, France
  • Asan Medical Center
    Songpa-gu, Seoul 05505, Korea, Republic of
09

References and documents

Study documents

  • Study protocol · Dec 2, 2019
  • Statistical analysis plan · Apr 29, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03936959
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
May 3, 2019
Start date
May 24, 2019
Primary completion
Mar 30, 2020
Completion
Apr 29, 2021
Results posted
Jan 15, 2025
Last update
Jan 15, 2025

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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