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Official 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

Phase
Phase 1
Sponsor
Eli Lilly and Company
Enrollment
535
Timeline
Jan 2023 → Jun 2027
About This Study

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 Criteria

Inclusion Criteria

  • 1Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable
  • 2Cohort A1: Presence of an alteration in FGFR3 or its ligands
  • 3Cohort A2, B2, B3, and B5: Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
  • 4Cohorts B1 and B4: Histological diagnosis of urothelial cancer that is locally advanced or metastatic
  • 5Cohort C1: Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
  • 6Measurability of disease:
  • 7Cohort A1 and B3: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)
  • 8Cohorts A2, B1, B2, B4, B5, and C1: Measurable disease required as defined by RECIST v1.1
  • 9Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review
  • 10Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Cohorts A1, A2, B3, and B5
  • 11Less than or equal to 2 for Cohorts B1, B2, B4, and C1
  • 12Prior Systemic Therapy Criteria:
  • 13Cohort 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.
  • 14Cohort 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
  • 15There is no restriction on number of prior therapies
  • 16Cohort B5: Participants have not received prior systemic therapy for locally advanced or metastatic UC
  • 17FGFR inhibitor specific requirements:
  • 18Cohort A1/A2/B3: Prior FGFR inhibitor treatment is permitted but not required
  • 19Cohort B1/B4: Participants must have been previously treated with erdafitinib
  • 20Cohort B2, B5, and C1: Participants must be FGFR inhibitor naïve

Exclusion Criteria

  • 1Participants with primary central nervous system (CNS) malignancy
  • 2Untreated or uncontrolled CNS metastases
  • 3Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible
  • 4Any serious unresolved toxicities from prior therapy
  • 5Significant cardiovascular disease
  • 6Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)
  • 7Active uncontrolled systemic infection or other clinically significant medical conditions
  • 8Participants 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

Locations

84 sites participating in this study

Emory University Hospital

Atlanta, Georgia 30322

Recruiting

University of Arizona - Cancer Center

Tucson, Arizona 85719

Recruiting

City of Hope

Duarte, California 91010

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →