FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

ID#: NCT05614739

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: January 19, 2023

End Date: June 01, 2025

Contact Information:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
13176154559
Summary: The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.
Eligibility:

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

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
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