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NCT Number: NCT07151040

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

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.

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Key information

Conditions

Solid Tumor Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Colonic Diseases Colorectal Cancer (CRC) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrooesophageal Junction Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer (NSCLC) Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institut Gustave Roussy, Villejuif, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TH9619

Drug

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.

Primary outcomes

  1. Frequency of treatment-emergent adverse events (TEAEs)

    Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.

  2. Incidence of severe treatment-emergent adverse events (TEAEs) per Common Terminology for Adverse Events (CTCAE) V5.0 grading

    Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.

  3. Incidence of treatment-emergent adverse events (TEAEs) related to treatment, as assessed by the Investigator

    Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.

  4. Frequency of serious adverse events (SAEs)

    Time frame: 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.

  5. Incidence of serious adverse events (SAEs) per the seriousness criteria defined in the protocol.

    Time frame: 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.

  6. Incidence of serious adverse events (SAEs) related to treatment, as assessed by the Investigator

    Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.

  7. Incidence of out of range clinical laboratory tests (as defined by the clinic) assessed as clinically significant by the Investigator

    Time frame: 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.

  8. Incidence of findings on vital signs parameters assessed as clinically significant by the Investigator

    Time frame: 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.

  9. Incidence of findings on ECHO/ECG assessed as clinically significant by the Investigator

    Time frame: 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.

  10. Incidence of findings during physical examinations assessed as clinically significant by the Investigator

    Time frame: 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.

  11. Incidence of treatment emergent adverse events (TEAEs) leading to dose interruptions/reductions and/or discontinuation of treatment

    Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria Moody

CONTACT

[email protected]

+46708555182

Sponsors and collaborators

Lead sponsor

One-carbon Therapeutics AB

Industry

Registry information

Official study title

A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of TH9619 in Subjects With Advanced Solid Tumors

Acronym: ODIN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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