FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Bladder Cancer
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
LOXO-FG3-22001 (primary)
NCI-2023-00367
022-502755-59-00
2022-502755-59-00
J4G-OX-JZVA
Summary
The main purpose of this study is to learn more about the safety, side effects, and
effectiveness of Vepugratinib by itself or when it is combined with other medicines that
treat cancer. Vepugratinib 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). Study participation could last up to approximately 6 years, depending on
which part of the study you join.
Objectives
This is an open-label, multi-center, phase 1 study in participants with FGFR3-altered
advanced solid tumor malignancy including metastatic urothelial cancer (UC),
muscle-invasive bladder cancer (MIBC), and low grade intermediate risk
non-muscle-invasive bladder cancer (LG IR NMIBC). The study will be conducted in 2
phases. Phase 1a will assess safety, tolerability, and pharmacokinetics of Vepugratinib
to determine the optimal dose for further expansion. Phase 1b will include dose expansion
cohorts to evaluate the efficacy and safety of Vepugratinib as monotherapy or in
combinations with other medicines that treat cancer.
Eligibility
- Cohort A1, C1, D1, and D2: Locally advanced or metastatic solid tumor malignancy with a qualifying FGFR3 alteration.
- Cohort A2, B2, B5 and B7: Urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration.
- Cohorts B1 and B4: Urothelial cancer that is locally advanced or metastatic and have received prior erdafitinib.
- Cohort B6: Muscle Invasive Bladder Cancer with a qualifying FGFR3 alteration.
- Cohort B7: Urothelial cancer that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration and expression of human epidermal growth factor receptor 2 (HER2).
- Cohort B8: Low Grade Intermediate Risk Non-Muscle Invasive Bladder cancer and a qualifying FGFR3 genetic alteration.
- Measurability of disease:
- Cohort A1, D1, and D2: 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, B7, and C1: Measurable disease required as defined by RECIST v1.1.
- Cohort B8: Baseline disease which includes at least 1 lesion.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of:
- 0 or 1 for Cohorts A1, A2, B5, B6, B7, and B8.
- Less than or equal to 2 for Cohorts B1, B2, B4, C1, DI and D2.
- Cohort B6: Must be eligible for radical cystectomy plus pelvic lymph node dissection and agree to undergo curative intent standard radical cystectomy plus pelvic lymph node dissection.
Treatment Sites in Georgia
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