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

One-carbon Therapeutics AB

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Drug: TH9619

Study type: Interventional

Funder types: Industry

Identifiers

NCT07151040

2024-519639-40-00 (EU Trial (CTIS) Number)

TH9619-0101

Details and patient eligibility

About

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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

43 participants in 1 patient group

Single arm dose

Experimental group

Description:

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.

Treatment:

Drug: TH9619