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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06400472




Registration number
NCT06400472
Ethics application status
Date submitted
30/04/2024
Date registered
6/05/2024

Titles & IDs
Public title
A Study of LY4170156 in Participants With Selected Advanced Solid Tumors
Scientific title
A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor a-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
Secondary ID [1] 0 0
2024-511238-11-00
Secondary ID [2] 0 0
LOXO-FRA-24001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasms 0 0
Endometrial Neoplasms 0 0
Uterine Cervical Neoplasms 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Triple Negative Breast Neoplasms 0 0
Pancreatic Neoplasm 0 0
Colorectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY4170156

Experimental: LY4170156 (Dose-escalation, Cohort A1) - Escalating doses of LY4170156 administered intravenously (IV).

Experimental: LY4170156 (Dose-optimization, Cohort A2) - Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV.

Experimental: LY4170156 (Dose-expansion, Cohort B1, B2, C1, C2) - LY4170156 administered IV.


Treatment: Drugs: LY4170156
Intravenous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156
Timepoint [1] 0 0
First 4 Cycles (21 days)
Primary outcome [2] 0 0
Phase 1a: To determine the RP2D or optimal dose of LY4170156
Timepoint [2] 0 0
First 4 Cycles (21 days)
Primary outcome [3] 0 0
Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)
Timepoint [3] 0 0
Up to Approximately 48 Months or 4 Years
Secondary outcome [1] 0 0
To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin)
Timepoint [1] 0 0
First 4 Cycles (21 days)
Secondary outcome [2] 0 0
To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC)
Timepoint [2] 0 0
First 4 Cycles (21 days)
Secondary outcome [3] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR)
Timepoint [3] 0 0
Up to Approximately 48 Months or 4 Years
Secondary outcome [4] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR)
Timepoint [4] 0 0
Up to Approximately 48 Months or 4 Years
Secondary outcome [5] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR)
Timepoint [5] 0 0
Up to Approximately 48 Months or 4 Years
Secondary outcome [6] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS)
Timepoint [6] 0 0
Up to Approximately 48 Months or 4 Years
Secondary outcome [7] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR)
Timepoint [7] 0 0
Up to Approximately 48 Months or 4 Years

Eligibility
Key inclusion criteria
* Have one of the following solid tumor cancers:

* Cohort A1: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), pancreatic, and colorectal cancer (CRC)
* Cohort A2/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer
* Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or pancreatic cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Individual with known or suspected uncontrolled central nervous system (CNS) metastases
* Individual with history of carcinomatous meningitis
* Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
* Individual with evidence of corneal keratopathy or history of corneal transplant
* Any serious unresolved toxicities from prior therapy
* Significant cardiovascular disease
* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) = 470 milliseconds (ms)
* History of pneumonitis/interstitial lung disease
* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Cancer Research SA - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
France
State/province [6] 0 0
Rhône
Country [7] 0 0
Japan
State/province [7] 0 0
Shizuoka
Country [8] 0 0
Japan
State/province [8] 0 0
Tokyo
Country [9] 0 0
Spain
State/province [9] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Loxo Oncology, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Emin Avsar
Address 0 0
Loxo Oncology, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
13176154559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
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/NCT06400472