Status: Recruiting

A Study of MT-4561 in Patients With Various Advanced Solid Tumors

This is a First In Human (FIH), multicenter, open-label, Phase I/II study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors. This study will be conducted in 3 parts. Part 1 is aimed at evaluating safety, tolerability, PK and pharmacodynamics of MT-4561 and determining the Maximum Tolerated Dose (MTD) using the Bayesian Optimal Interval (BOIN) design. The study details and doses of Part 2 (dose-optimization) and Part 3 (Drug-Drug Interaction) will be available after review of applicable Part 1 results.

Participants needed: 27

Trial details

Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Tanabe Pharma America, Inc.Updated: Dec 11, 2025Locations: 6

Eligibility criteria

Male or female patient aged 18 years or older at the time of signing the informe... [+7]

Patients with active brain or leptomeningeal metastases [+5]

Status: Recruiting

Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

To evaluate the long-term safety and tolerability of oral dersimelagon.

Participants needed: 301

Trial details

Phase: Phase 3Age: 12-75Biological sex: AllType: InterventionalSponsor: Tanabe Pharma America, Inc.Updated: Dec 11, 2025Locations: 51

Eligibility criteria

1. Subjects provided written informed consent to participate. For adolescent sub... [+5]

1. History or presence of photodermatoses other than EPP or XLP. [+18]

Clinical trials

A Study of MT-4561 in Patients With Various Advanced Solid Tumors

Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)