At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- TH9619 (drug)
- How long the study runs
- Study runs about 16 months (dates as stated)
- About the drug or intervention
- TH9619 — drug: Phase 1a - DOSE ESCALATION Description: Single arm dose escalation of TH9619 as monotherapy.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 43
- Started
- 2025-08-22
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for solid tumor
- • Phase1/Phase2 - 43 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with solid tumor
Where?
- • Newcastle upon Tyne - Newcastle University
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
Solid TumorColorectal Cancer (CRC)Squamous Cell Carcinoma of Head and NeckNon-Small Cell Lung Cancer (NSCLC)Gastrooesophageal Junction CancerGastric Cancer
How this trial compares with your answers
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What we know so far
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ given written informed consent
- ✓ at least one line of cytotoxic systemic therapy f
What the study is looking for
- ✓Must have given written agreement to take part
- ✓Histopathologically confirmed advanced cancer (colorectal cancer, head and neck squamous cell cancer, non-small cell...
- ✓Prior treatment with at least one line of cytotoxic treatment that goes through your whole body for that has spread/unresectable cancer
- ✓Adult patients (≥18 years of age)
- ✓Must be willing to comply with study procedures
Who cannot take part
- ✗History or presence of any clinically significant disorders as judged by the Investigator.
See the full criteria
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.
Where Is This Study? (1 UK site)
Newcastle University
Newcastle upon Tyne, United Kingdom
How to Get in Touch
Victoria Moody
Sponsor contactCONTACT
+46708555182 victoria.moody@one-carbon.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-01