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

NCT07151040 | Recruiting Phase 1

• 2 other identifiers: TH9619-01012024-519639-40-00
• Study Type: interventional
• Target: 43
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Solid Tumor; Colorectal Cancer (CRC); Squamous Cell Carcinoma of Head and Neck; Non-Small Cell Lung Cancer (NSCLC); Gastrooesophageal Junction Cancer; Gastric Cancer

Outcome Measures

Primary Outcomes (11)

• 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.

Study Arms (1)

Single arm dose

EXPERIMENTAL

Phase 1a (escalation) Single arm dose escalation of TH9619 as monotherapy. Phase 1b (expansion) Single arm dose expansion of TH9619 as monotherapy in selected tumor types.

Drug: TH9619

Interventions

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.

Single arm dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History or presence of any clinically significant disorders as judged by the Investigator.

Sponsors & Collaborators

• One-carbon Therapeutics AB: lead

Study Sites (4)

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

MeSH Terms

Conditions

Colorectal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Stomach Diseases

Central Study Contacts

Victoria Moody

CONTACT

+46708555182; victoria.moody@one-carbon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: September 2, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

GB (1); ES (2); FR (1)