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

Not Applicable

Recruiting

• 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

• Registration Number: NCT07151040
• Lead Sponsor: One-carbon Therapeutics AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-13
• Status Verified: 2025-08
• Study Start: 2025-08-22
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-02
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm dose	TH9619	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.

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (4)

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Vall D Hebron Institute Of Oncology; 🇪🇸 Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Newcastle University; 🇬🇧 Newcastle upon Tyne, United Kingdom