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Clinical Trials in the UK / NCT07151040
Recruiting Phase 1/2

Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors

NCT07151040 · tracked via the Priya Life Science UK tracker
Sponsor
One-carbon Therapeutics AB
Phase
Phase 1/2
Started
2025-08-22
Last updated
2026-01-28

Condition(s) studied

Solid TumorColorectal Cancer (CRC)Squamous Cell Carcinoma of Head and NeckNon-Small Cell Lung Cancer (NSCLC)Gastrooesophageal Junction CancerGastric Cancer

Investigational drug(s) / intervention(s)

TH9619

TH9619: Phase 1a - DOSE ESCALATION Description: Single arm dose escalation of TH9619 as monotherapy. Phase 1b - DOSE EXPANSION Description: Single arm dose expansion of TH9619 as monotherapy in selected tumor types. The objectives and endpoints for the expansion cohort(s) will be defined in a protocol amendment, once data from Phase 1a are available.

Study summary

This is a first in human, multi-center, open-label, dosage escalation study to determine the recommended dose range of TH9619 in subjects with advanced cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Must have given written informed consent * Histopathologically confirmed advanced cancer (colorectal cancer, head and neck squamous cell cancer, non-small cell lung cancer and gastric cancer (including gastroesophageal junction cancer)) * Prior treatment with at least one line of cytotoxic systemic therapy for metastatic/unresectable cancer * Adult patients (≥18 years of age) * Must be willing to comply with study procedures Exclusion Criteria: • History or presence of any clinically significant disorders as judged by the Investigator.

Primary outcome measure(s)

  • Frequency of treatment-emergent adverse events (TEAEs) — From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
  • Incidence of severe treatment-emergent adverse events (TEAEs) per Common Terminology for Adverse Events (CTCAE) V5.0 grading — From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
  • Incidence of treatment-emergent adverse events (TEAEs) related to treatment, as assessed by the Investigator — From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
  • Frequency of serious adverse events (SAEs) — From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
  • Incidence of serious adverse events (SAEs) per the seriousness criteria defined in the protocol. — From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
  • Incidence of serious adverse events (SAEs) related to treatment, as assessed by the Investigator — From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
  • Incidence of out of range clinical laboratory tests (as defined by the clinic) assessed as clinically significant by the Investigator — From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
  • Incidence of findings on vital signs parameters assessed as clinically significant by the Investigator — From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
  • Incidence of findings on ECHO/ECG assessed as clinically significant by the Investigator — From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
  • Incidence of findings during physical examinations assessed as clinically significant by the Investigator — From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
  • Incidence of treatment emergent adverse events (TEAEs) leading to dose interruptions/reductions and/or discontinuation of treatment — From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.

Trial sites (4)

FacilityCityRegionStatus
Institut Gustave Roussy Villejuif France Recruiting
Vall D Hebron Institute Of Oncology Barcelona Spain Recruiting
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain Recruiting
Newcastle University Newcastle upon Tyne United Kingdom Recruiting

Other trials for the same condition

A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer Recruiting
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors Recruiting
A Study of Sigvotatug Vedotin in Advanced Solid Tumors Recruiting
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Recruiting
Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07151040 on ClinicalTrials.gov ↗ ← All trials in the UK