NCT04099277 · REGISTRY CONDITION SEARCH

A Study of LY3435151 in Participants With Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: TERMINATED
Registry last update: 2021-08-31

The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With LY3435151 Dose-Limiting Toxicities (DLTs)

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outcome · POSTED

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151

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outcome · POSTED

PK: Cmax of LY3435151 in Combination With Pembrolizumab

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outcome · POSTED

Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)

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outcome · POSTED

Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease

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outcome · POSTED

Duration of Response (DoR)

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outcome · POSTED

Time to Response (TTR)

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outcome · POSTED

Progression Free Survival (PFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Participant must have certain types of cancer, which your study doctor will discuss with you * Participant must have stopped other forms of treatment for cancer, which your study doctor will discuss with you * Participant must be able and willing to provide a sample of your tumor before beginning treatment and once while on treatment. For certain tumor types, the outcome of the biopsy may exclude you from the study treatment (for Phase 1b) * Participant must agree to use birth control * Participant must have progressed through or are intolerant to therapies with known clinical benefit, which your study doctor will discuss with you Exclusion Criteria: * Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled hepatitis B or C virus infection * Participant must not have an autoimmune disease, which your study doctor will discuss with you * Participant must not use corticosteroids, which your study doctor will discuss with you * Participant must not have heart disease, Crohn's disease or brain cancer * Participant must not be pregnant or breastfeeding
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants received intravenous (IV) push or IV bolus infusion of 10 mg LY3435151.
intervention Names
Drug: LY3435151
label
Part A: 10 milligrams (mg) LY3435151
type
EXPERIMENTAL
description
Pembrolizumab was not administered as study was terminated before completion of Part A of the dose escalation period.
intervention Names
Drug: LY3435151
Drug: Pembrolizumab
label
Part B: LY3435151 + Pembrolizumab Dose Escalation
type
EXPERIMENTAL
description
Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase.
intervention Names
Drug: LY3435151
label
Part C: LY3435151 Dose Expansion
type
EXPERIMENTAL
description
Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase.
intervention Names
Drug: LY3435151
Drug: Pembrolizumab
label
Part D: LY3435151 + Pembrolizumab Dose Expansion
type
EXPERIMENTAL

interventions

arm Group Labels
Part A: 10 milligrams (mg) LY3435151
Part B: LY3435151 + Pembrolizumab Dose Escalation
Part C: LY3435151 Dose Expansion
Part D: LY3435151 + Pembrolizumab Dose Expansion
description
Administered IV
name
LY3435151
type
DRUG
arm Group Labels
Part B: LY3435151 + Pembrolizumab Dose Escalation
Part D: LY3435151 + Pembrolizumab Dose Expansion
description
Administered IV
name
Pembrolizumab
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 2
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
A DLT is defined as an Adverse Event that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0: 1. Any death not clearly due to the underlying disease or extraneous causes 2. Neutropenic fever 2. Any Grade ≥3 non-hematologic toxicity 3. Grade ≥4 neutropenia or thrombocytopenia \>7 days 4. Grade ≥3 thrombocytopenia with bleeding 5. Grade ≥3 nausea/vomiting or diarrhea\>72 hours with adequate antiemetic and other supportive care 6. Grade ≥3 fatigue ≥1 week 7. Grade ≥3 electrolyte abnormality that lasts\>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT 8. Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.
measure
Number of Participants With LY3435151 Dose-Limiting Toxicities (DLTs)
time Frame
Baseline through Cycle 2 (21 Day Cycles)

secondary Outcomes

description
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151.
measure
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151
time Frame
Cycle 1 Day 1 (C1D1) (Predose, 1, 3 hour (hr), C1D2 (24 hr), C1D4 (72hr), C1D8 (168hr), C1D15 (336hr)
description
PK: Cmax of LY3435151 in Combination with Pembrolizumab.
measure
PK: Cmax of LY3435151 in Combination With Pembrolizumab
time Frame
Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles)
description
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100.
measure
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
time Frame
Baseline through Disease Progression or Death (Up to 4 Months)
description
Disease Control Rate (DCR) is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
measure
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease
time Frame
Baseline through Measured Progressive Disease (Up to 4 Months)
description
DOR is the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
measure
Duration of Response (DoR)
time Frame
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 4 Months)
description
Time to response (TTR) is defined as the time from the date of start of treatment to the date measurement criteria for confirmed CR or PR (whichever is first recorded) are first met. For participants who are not known to have achieved CR or PR as of the data inclusion cut-off date, TTR will be censored at the date of the last objective disease assessment prior the date of any subsequent systematic anticancer therapy.
measure
Time to Response (TTR)
time Frame
Baseline to Date of CR or PR (Up to 4 Months)
description
PFS time was measured from the date of randomization until the first radiographic documentation of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
measure
Progression Free Survival (PFS)
time Frame
Baseline to Objective Progression or Death Due to Any Cause (Up to 4 Months)

Full study description

brief Summary: The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.

Source references