Phase I Study of TAS-120 in Patients with Advanced Solid Tumors

A PHASE I, OPEN-LABEL, NON-RANDOMIZED, DOSE-ESCALATING, SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC AND EFFICACY STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS,

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222501

Enrollment

142

Registered

2014-05-28

Start date

2014-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Patients with advanced solid tumors

Interventions

investigational material(s) Generic name etc : TAS-120 Covalent FGFR (fibroblast growth factor receptor) inhibitor INN of investigational material : - Therapeutic category code : 429 Other antitumor a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provided written informed consent for treatment. 2. 20 years of age or older at enrollment. 3. Histologically or cytologically confirmed advanced or metastatic solid tumor(s) without standard treatment remains. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on time of patient's allocation.

Exclusion criteria

Exclusion criteria: 1. A serious illness or medical conditions. 2. Known hypersensitivity to any drugs similar to TAS-120 in structure or class. 3. Pregnant or lactating female or women of child-bearing potential who have a positive pregnancy test (urine or serum) within 7 days prior to starting the study drug.

Design outcomes

Primary

Measure	Time frame
safety Safety CTCAE (ver.4.03)	—

Secondary

Measure	Time frame
efficacy pharmacokinetics Pharmacokinetics, Efficacy RECIST (ver.1.1)	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026