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

NCT07151040 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-01-28

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • One-carbon Therapeutics AB

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-22
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07151040 on ClinicalTrials.gov