deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 4-arm NCT05784688

Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors

A Phase 1b/2a Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Serine/Threonine Kinase Inhibitor, Administered in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Sponsor: Merck Sharp & Dohme LLC

Conditions Biliary Tract Cancer Colorectal Cancer Head and Neck Squamous Cell Carcinoma Solid Tumor
Interventions TU2218 + KEYTRUDA® (Pembrolizumab)
Updated 8 times since 2023 Last updated: Mar 25, 2025 Started: Mar 10, 2023 Primary completion: Dec 31, 2026 Completion: Dec 31, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Biliary Tract Cancer and Colorectal Cancer, this trial is actively recruiting participants. The trial is conducted by Merck Sharp & Dohme LLC and has accumulated 8 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Apr 2023 – ~Jun 2023 · 2 months · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshotRecruiting~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshotRecruiting~Sep 2025 – present · 10 months · monthly snapshotRecruiting

Change History

8 versions recorded

  1. Sep 2025 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. Apr 2025 — Sep 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Mar 2025 — Apr 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Sep 2024 — Mar 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

▶ Show 3 earlier versions

  1. Jul 2023 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  2. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE1_PHASE2

  3. Apr 2023 — Jun 2023 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Mar 2023

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck Sharp & Dohme LLC
  • TiumBio Co., Ltd.
Data source: TiumBio Co., Ltd.

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

Study Locations