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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06465069




Registration number
NCT06465069
Ethics application status
Date submitted
13/06/2024
Date registered
18/06/2024

Titles & IDs
Public title
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Scientific title
A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors
Secondary ID [1] 0 0
J5I-OX-JZYA
Secondary ID [2] 0 0
LOXO-LNC-24001
Universal Trial Number (UTN)
Trial acronym
NEXUS-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Solid Tumor 0 0
Recurrent Solid Tumor 0 0
Advanced Solid Tumor 0 0
Urinary Bladder Neoplasm 0 0
Triple Negative Breast Cancer 0 0
Non-small Cell Lung Cancer 0 0
Esophageal Cancer 0 0
Pancreatic Cancer 0 0
Ovarian Cancer 0 0
Cervical Cancer 0 0
Head and Neck Squamous Cell Carcinoma 0 0
Prostate Cancer 0 0
Renal Pelvis Cancer 0 0
Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bladder - transitional cell cancer
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY4052031

Experimental: LY4052031 (Dose-escalation, Cohort A1) - Escalating doses of LY4052031 administered intravenously (IV).

Experimental: LY4052031 (Dose-optimization, Cohort A2) - Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.

Experimental: LY4052031 (Dose-expansion, Cohort B1, B2, C1) - LY4052031 administered IV.


Treatment: Drugs: LY4052031
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) or optimal dose of LY4052031
Timepoint [1] 0 0
Cycle 1 (21 Days)
Primary outcome [2] 0 0
Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR)
Timepoint [2] 0 0
Up to Approximately 48 Months or 4 Years]
Secondary outcome [1] 0 0
To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)
Timepoint [1] 0 0
Cycle 1 (21 Days)
Secondary outcome [2] 0 0
To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC)
Timepoint [2] 0 0
Cycle 1 (21 Days)
Secondary outcome [3] 0 0
To evaluate the preliminary antitumor activity of LY4052031: 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 LY4052031: 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 LY4052031: 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 LY4052031: 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 LY4052031: Disease control rate (DCR)
Timepoint [7] 0 0
Up to Approximately 48 Months or 4 Years
Secondary outcome [8] 0 0
To evaluate the preliminary antitumor activity of LY4052031: Overall survival (OS)
Timepoint [8] 0 0
Up to Approximately 48 Months or 4 Years

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

* Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
* Cohort A2/B1/B2: urothelial carcinoma
* Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, head and neck squamous cell carcinoma, esophageal cancer, pancreatic cancer, or prostate cancer
* Prior Systemic Therapy Criteria:

* Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
* Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
* Prior enfortumab vedotin specific requirements:

* Cohorts A1/A2/C: prior treatment with enfortumab vedotin is allowed, but not required
* Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
* Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
* Measurability of disease

* Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
* Cohorts A2, B1, B2, C: measurable disease required as defined by RECIST v1.1
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations
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 CNS metastases
* Individual with uncontrolled hypercalcemia
* Individual with uncontrolled diabetes
* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
* Any serious unresolved toxicities from prior therapy
* Significant cardiovascular disease
* Recent thromboembolic event or bleeding disorder
* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) = 470 ms
* History of pneumonitis/interstitial lung disease
* History of Grade =3 skin toxicity when receiving enfortumab vedotin
* 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
Non-randomised 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
1/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
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
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
Japan
State/province [6] 0 0
Tokyo
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul-teukbyeolsi
Country [8] 0 0
Spain
State/province [8] 0 0
Andalucía
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Greater Manchester
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London

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
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/NCT06465069