Register a trial

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
18863
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
Treatment: Drugs - Bevacizumab
Treatment: Drugs - carboplatin

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.

Experimental: LY4170156 (Enrichment Cohort A3) - Monotherapy administered IV

Experimental: LY4170156 (Combination Cohort A4) - Combination with bevacizumab administered IV

Experimental: LY4170156 (Combination Cohort A5) - Combination with carboplatin administered IV


Treatment: Drugs: LY4170156
Intravenous

Treatment: Drugs: Bevacizumab
IV

Treatment: Drugs: carboplatin
IV
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
1 Cycle (21 days)
Primary outcome [2] 0 0
Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab
Timepoint [2] 0 0
1 Cycle (21 days)
Primary outcome [3] 0 0
Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin
Timepoint [3] 0 0
1 Cycle (21 days)
Primary outcome [4] 0 0
Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)
Timepoint [4] 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 (84 days)
Secondary outcome [2] 0 0
To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin) with vevacizumab or carboplatin
Timepoint [2] 0 0
First 4 Cycles (84 days)
Secondary outcome [3] 0 0
To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC)
Timepoint [3] 0 0
First 4 Cycles (84 days)
Secondary outcome [4] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR)
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: Overall response rate (ORR) with bevacizumab or carboplatin
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: Duration of response (DOR)
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: Duration of response (DOR) with bevacizumab or carboplatin
Timepoint [7] 0 0
Up to Approximately 48 Months or 4 Years]
Secondary outcome [8] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR)
Timepoint [8] 0 0
Up to Approximately 48 Months or 4 Years
Secondary outcome [9] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) with bevacizumab or carboplatin
Timepoint [9] 0 0
Up to Approximately 48 Months or 4 Years]
Secondary outcome [10] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS)
Timepoint [10] 0 0
Up to Approximately 48 Months or 4 Years
Secondary outcome [11] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) with bevacizumab or carboplatin
Timepoint [11] 0 0
Up to Approximately 48 Months or 4 Years]
Secondary outcome [12] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR)
Timepoint [12] 0 0
Up to Approximately 48 Months or 4 Years
Secondary outcome [13] 0 0
To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR) with bevacizumab or carboplatin
Timepoint [13] 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/A3/A4/A5/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
20/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Icon Cancer Centre South Brisbane Loc. 10 - South Brisbane
Recruitment hospital [2] 0 0
Cancer Research SA - Adelaide
Recruitment postcode(s) [1] 0 0
4066 - South Brisbane
Recruitment postcode(s) [2] 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
Korea, Republic of
State/province [9] 0 0
Gyeonggi-do
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
Valencia

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
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
[email protected]
Contact person for scientific queries

Data sharing statement


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