deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT06943521

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

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

Sponsor: Tanabe Pharma America, Inc.

Conditions Biliary Tract Cancer Breast Cancer Cervical Cancer Endometrial Cancer Esophageal Cancer Gastric Cancer Head and Neck Squamous Cell Carcinoma (HNSCC) Neuroendocrine Carcinoma (NEC) Neuroendocrine Tumor (NET) Non-small Cell Lung Cancer (NSCLC) Nuclear Protein in Testis (NUT) Carcinoma Ovarian Cancer Pancreatic Ductal Adenocarcinoma (PDAC) Prostate Cancer Soft Tissue Sarcoma Urothelial Carcinoma
Interventions MT-4561
Updated 6 times since 2025 Last updated: Dec 4, 2025 Started: Apr 18, 2025 Primary completion: Aug 31, 2028 Completion: Aug 31, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Biliary Tract Cancer and Breast Cancer and is currently actively recruiting participants. Tanabe Pharma America, Inc. leads this study, which shows 6 recorded versions since 2025 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Aug 2025 · 2 months · monthly snapshotRecruiting~Aug 2025 – ~Oct 2025 · 2 months · monthly snapshotRecruiting~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Jan 2026 · 2 months · monthly snapshotRecruiting~Jan 2026 – present · 5 months · monthly snapshotRecruiting

Change History

6 versions recorded

  1. Jan 2026 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. Nov 2025 — Jan 2026 [monthly]

    Recruiting PHASE1/PHASE2

  3. Oct 2025 — Nov 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Aug 2025 — Oct 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Jun 2025 — Aug 2025 [monthly]

    Recruiting PHASE1/PHASE2

    Status: Not Yet Recruiting → Recruiting

▶ Show 1 earlier version

  1. May 2025 — Jun 2025 [monthly]

    Not Yet Recruiting PHASE1/PHASE2

    First recorded

Apr 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Tanabe Pharma America, Inc.
Data source: Tanabe Pharma America, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations