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

Conditions

• Neoplasm Metastasis
• Ureteral Neoplasms
• Urinary Bladder Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vepugratinib — DRUG
  Oral
• Pembrolizumab — DRUG
  IV
• enfortumab vedotin — DRUG
  IV
• Trastuzumab Deruxtecan — DRUG
  IV
• Midazolam — DRUG
  Oral
• Digoxin — DRUG
  Oral
• Rosuvastatin — DRUG
  Oral

Study Details

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.

Key Dates

First listed

Nov 14, 2022

Start date

Jan 12, 2023

Status verified

Aug 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

677 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1a: Cohort A1 Vepugratinib Monotherapy Dose Escalation
  Vepugratinib administered orally
• Experimental: Phase 1a: Cohort A2 Vepugratinib Monotherapy Dose Optimization
  Vepugratinib administered orally
• Experimental: Phase 1b: Cohort B1, B2, B4, C1, and D1 Vepugratinib Monotherapy Dose Expansion
  Vepugratinib administered orally
• Experimental: Phase 1b: Cohort B5 Vepugratinib Plus Pembrolizumab Plus Enfortumab Vedotin
  Vepugratinib administered orally in combination with pembrolizumab administered IV and enfortumab vedotin administered IV
• Experimental: Phase 1b: MIBC Cohort B6 Vepugratinib Plus Pembrolizumab Plus Enfortumab Vedotin
  Vepugratinib administered orally in combination with pembrolizumab administered IV and enfortumab vedotin administered IV
• Experimental: Experimental: Phase 1b: Cohort B7 Vepugratinib Plus Trastuzumab Deruxtecan
  Vepugratinib administered orally in combination with trastuzumab deruxtecan administered IV
• Experimental: Phase 1b: NMIBC Cohort B8 Vepugratinib Monotherapy Dose Expansion
  Vepugratinib administered orally
• Experimental: Phase 1b: Cohort D2 (Drug to Drug Interaction)
  Vepugratinib Plus Midazolam Plus Digoxin Plus Rosuvastatin (Lead-In Only) followed by Vepugratinib Monotherapy Vepugratinib administered orally Midazolam with digoxin with rosuvastatin administered orally once per cycle for 2 cycles.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to Approximately 30 Months or 2.5 Years ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (41)

Find similar trials in Tucson, AZ

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