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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05614739




Registration number
NCT05614739
Ethics application status
Date submitted
7/11/2022
Date registered
14/11/2022

Titles & IDs
Public title
FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
Scientific title
FORAGER-1: A Phase 1, Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer With FGFR3 Alterations
Secondary ID [1] 0 0
J4G-OX-JZVA
Secondary ID [2] 0 0
18594
Universal Trial Number (UTN)
Trial acronym
FORAGER-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Neoplasms 0 0
Neoplasm Metastasis 0 0
Ureteral Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LOXO-435
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - enfortumab vedotin

Experimental: Phase 1a: Cohort A1 LOXO-435 Monotherapy Dose Escalation - LOXO-435 administered orally

Experimental: Phase 1a: Cohort A2 LOXO-435 Monotherapy Dose Optimization - LOXO-435 administered orally

Experimental: Phase 1b: Cohort B1, B2, B4, and C1 LOXO-435 Monotherapy Dose Expansion - LOXO-435 administered orally

Experimental: Phase 1b: Cohort B3 LOXO-435 Plus Pembrolizumab - LOXO-435 administered orally in combination with pembrolizumab administered intravenously (IV)

Experimental: Phase 1b: Cohort B5 LOXO-435 Plus Pembrolizumab Plus Enfortumab Vedotin - LOXO-435 administered orally in combination with pembrolizumab administered IV and enfortumab vedotin administered IV


Treatment: Drugs: LOXO-435
Oral

Treatment: Drugs: Pembrolizumab
IV

Treatment: Drugs: enfortumab vedotin
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 dose of LOXO-435: Safety, number of participants with dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
Minimum of the first 21-day cycle of LOXO-435 treatment
Primary outcome [2] 0 0
Phase 1b: To evaluate the preliminary antitumor activity of LOXO-435: Overall response rate (ORR)
Timepoint [2] 0 0
Up to approximately 30 months or 2.5 years
Primary outcome [3] 0 0
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Timepoint [3] 0 0
Up to approximately 30 months or 2.5 years
Secondary outcome [1] 0 0
To assess the pharmacokinetics (PK) of LOXO-435: Area under the concentration versus time curve (AUC)
Timepoint [1] 0 0
Up to 2 months
Secondary outcome [2] 0 0
To assess the PK of LOXO-435: Minimum plasma concentration (Cmin)
Timepoint [2] 0 0
Up to 2 months
Secondary outcome [3] 0 0
To evaluate the preliminary antitumor activity of LOXO-435: Objective response rate (ORR)
Timepoint [3] 0 0
Up to approximately 30 months or 2.5 years]
Secondary outcome [4] 0 0
To evaluate the preliminary antitumor activity of LOXO-435: Duration of response (DoR)
Timepoint [4] 0 0
Up to approximately 30 months or 2.5 years
Secondary outcome [5] 0 0
To evaluate the preliminary antitumor activity of LOXO-435: Time to response (TTR)
Timepoint [5] 0 0
Up to approximately 30 months or 2.5 years
Secondary outcome [6] 0 0
To evaluate the preliminary antitumor activity of LOXO-435: Progression-free survival (PFS)
Timepoint [6] 0 0
Up to approximately 30 months or 2.5 years
Secondary outcome [7] 0 0
To evaluate the preliminary antitumor activity of LOXO-435: Disease control rate (DCR)
Timepoint [7] 0 0
Up to approximately 30 months or 2.5 years
Secondary outcome [8] 0 0
To evaluate the preliminary antitumor activity of LOXO-435: Overall survival (OS)
Timepoint [8] 0 0
Up to approximately 30 months or 2.5 years
Secondary outcome [9] 0 0
Change from baseline in bladder-related symptoms, measured by Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) subscale (BlCS)
Timepoint [9] 0 0
Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 3 Day 1 (28 day cycles)
Secondary outcome [10] 0 0
Change from baseline in physical function, measured by FACT- Physical Well-being Scale (PWB) subscale
Timepoint [10] 0 0
Up to approximately 30 months or 2.5 years

Eligibility
Key inclusion criteria
* Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable

* Cohort A1: Presence of an alteration in FGFR3 or its ligands
* Cohort A2, B2, B3, and B5: Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
* Cohorts B1 and B4: Histological diagnosis of urothelial cancer that is locally advanced or metastatic
* Cohort C1: Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
* Measurability of disease:

* Cohort A1 and B3: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)
* Cohorts A2, B1, B2, B4, B5, and C1: Measurable disease required as defined by RECIST v1.1
* Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Cohorts A1, A2, B3, and B5

* Less than or equal to 2 for Cohorts B1, B2, B4, and C1
* Prior Systemic Therapy Criteria:

* Cohort A1/C1: Participant has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating Investigator; OR the participant is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies.
* Cohort A2, B2, B3 participants must have received at least one prior regimen, and cohorts B1 and B4 participants at least 2 prior regimens, in the locally advanced or metastatic setting
* There is no restriction on number of prior therapies
* Cohort B5: Participants have not received prior systemic therapy for locally advanced or metastatic UC
* FGFR inhibitor specific requirements:

* Cohort A1/A2/B3: Prior FGFR inhibitor treatment is permitted but not required
* Cohort B1/B4: Participants must have been previously treated with erdafitinib
* Cohort B2, B5, and C1: Participants must be FGFR inhibitor naïve
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with primary central nervous system (CNS) malignancy
* Untreated or uncontrolled CNS metastases
* Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible
* Any serious unresolved toxicities from prior therapy
* Significant cardiovascular disease
* Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)
* Active uncontrolled systemic infection or other clinically significant medical conditions
* Participants who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment. Participants who have stopped breastfeeding may be enrolled

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
Other
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
12/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
535
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Vermont
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
China
State/province [25] 0 0
Beijing
Country [26] 0 0
China
State/province [26] 0 0
Guangdong
Country [27] 0 0
China
State/province [27] 0 0
Shaanxi
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Zhejiang
Country [30] 0 0
China
State/province [30] 0 0
Tianjin
Country [31] 0 0
France
State/province [31] 0 0
Rhône-Alpes
Country [32] 0 0
France
State/province [32] 0 0
Bordeaux
Country [33] 0 0
France
State/province [33] 0 0
Villejuif Cedex
Country [34] 0 0
Germany
State/province [34] 0 0
Württemberg
Country [35] 0 0
Germany
State/province [35] 0 0
München
Country [36] 0 0
Israel
State/province [36] 0 0
Ramat Gan
Country [37] 0 0
Israel
State/province [37] 0 0
Petah Tiqva
Country [38] 0 0
Italy
State/province [38] 0 0
Milan
Country [39] 0 0
Italy
State/province [39] 0 0
Roma
Country [40] 0 0
Japan
State/province [40] 0 0
Aichi
Country [41] 0 0
Japan
State/province [41] 0 0
Chiba
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Netherlands
State/province [44] 0 0
Zuid-Holland
Country [45] 0 0
Norway
State/province [45] 0 0
Bergen
Country [46] 0 0
Norway
State/province [46] 0 0
Oslo
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Santander
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Manchester
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Sheffield

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/NCT05614739