Phase I study of AMY109 in patients with advanced solid tumors

Phase I study of AMY109 in combination with antineoplastic drugs in patients with advanced solid tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225101

Enrollment

120

Registered

2020-02-28

Start date

2020-03-16

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

advanced/recurrent solid tumors

Interventions

investigational material(s) Generic name etc : AMY109 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Aged >20 years at time of informed consent - Eastern Cooperative Oncology Group(ECOG) Performance Status (PS) of 0 or 1 - Life expectancy >12 weeks from date of enrollment - Histologically or cytologically documented solid tumor - Advanced or recurrent cancer for which standard therapy is ineffective or inappropriate, or for which no standard therapy exists

Exclusion criteria

Exclusion criteria: - Concurrent or prior autoimmune disease - Uncontrolled diabetes mellitus - Concurrent New York Heart Association (NYHA) Class >II congestive heart failure, myocardial infarction, arrhythmia, or unstable angina, or a history thereof within 6 months before enrollment - Concurrent symptomatic cerebrovascular disorder or a history thereof within 6 months before enrollment

Design outcomes

Primary

Measure	Time frame
safety pharmacokinetics NCI CTCAE	—

Secondary

Measure	Time frame
efficacy RECIST	—

Countries

Japan

Outcome results

None listed

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