A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects with Metastatic or Locally Advanced Urothelial Cancer

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510295-31-00

Acronym

42756493BLC2002

Enrollment

Registered

2024-03-25

Start date

2018-09-24

Completion date

Unknown

Last updated

2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic or Locally Advanced Urothelial Cancer

Brief summary

Phase 1b (Dose Escalation) - Frequency and type of dose-limiting toxicity (DLT)., Phase 2 (Dose Expansion) - Overall response rate (ORR) (partial response [PR] or better) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment - Incidence of AEs.

Interventions

DRUGCISPLATIN

DRUGJNJ-42756493

DRUGCARBOPLATIN

DRUGJNJ-63723283

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 1b (Dose Escalation) - Frequency and type of dose-limiting toxicity (DLT)., Phase 2 (Dose Expansion) - Overall response rate (ORR) (partial response [PR] or better) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment - Incidence of AEs.	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026