Solid TumorPhase 1/2ODINNCT07151040
Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors
A Phase 1/2 study testing TH9619 in people with Solid Tumor and Colorectal Cancer (CRC), run by One-carbon Therapeutics AB at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Colorectal Cancer (CRC), Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- TH9619
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 22 Aug 2025to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History or presence of any clinically significant disorders as judged by the Investigator.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Spain2 sites, 2 recruiting
- Recruiting
Vall D Hebron Institute Of Oncology
Barcelona
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid
United Kingdom1 site, 1 recruiting
- Recruiting
Newcastle University
Newcastle upon Tyne
About this study
Official title: A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of TH9619 in Subjects With Advanced Solid Tumors
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
- Being tested
- TH9619
- Medical subject headings
- Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TH9619Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TH9619 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of treatment-emergent adverse events (TEAEs)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start22 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- One-carbon Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151040
- Sponsor's protocol ID
- TH9619-0101
- Other IDs
- 2024-519639-40-00
- Acronym
- ODIN
- Status last verified
- Jan 2026
- First submitted
- 13 Jun 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of TH9619 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07151040
- Acronym / sponsor ID
- ODIN / TH9619-0101
- Conditions
- Solid Tumor, Colorectal Cancer (CRC), Squamous Cell Carcinoma of Head and Neck, Non-Small Cell Lung Cancer (NSCLC), Gastrooesophageal Junction Cancer, Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- One-carbon Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm dose | Experimental | Drug: TH9619Phase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- History or presence of any clinically significant disorders as judged by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TH9619Phase 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. | Drug | Single arm dose |
Primary outcome
Frequency of treatment-emergent adverse events (TEAEs)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TH9619 in people with Solid Tumor and Colorectal Cancer (CRC), run by One-carbon Therapeutics AB at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Moody (+46708555182, victoria.moody@one-carbon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment-emergent adverse events (TEAEs) (time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.