Solid TumorPhase 1/2NCT07873450
SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
A Phase 1/2 study testing [225Ac]Ac-FL-261 in people with Solid Tumor and NSCLC, run by Full-Life Technologies UK Limited at 1 site in Australia.
Trial summary
This is a first-in-human, multicenter, open-label Phase 1/2 study designed to evaluate the safety, efficacy, and tolerability of [225Ac]Ac-FL-261, a targeted radioligand therapy directed at c-MET, in participants with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, NSCLC, Colorectal Cancer
- What is being tested?
- [225Ac]Ac-FL-261
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Oct 2026to 30 Jun 2030
- 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
- They have signed the consent form before any study-related tests or procedures are done and are willing to follow all study requirements.
- They are 18 years of age or older.
- They have a confirmed diagnosis of an advanced or metastatic cancer that cannot be cured with surgery, radiation, or other treatments.
- Phase 1: Non-squamous non-small cell lung cancer (ns-NSCLC).
- Phase 2: Non-squamous non-small cell lung cancer (ns-NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), or cholangiocarcinoma (bile duct cancer).
- Their cancer has worsened after previous treatments, or they cannot receive further standard treatments because of reasons such as side effects or medical conditions.
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- For lung cancer (ns-NSCLC): Previously treated with chemotherapy, immunotherapy, and targeted therapies if applicable.
- For colorectal cancer (CRC): Previously treated with standard chemotherapy and other suitable targeted or immune therapies if specific genetic changes were present.
- For head and neck cancer (HNSCC): Previously treated with platinum-based chemotherapy and immunotherapy.
- For cholangiocarcinoma: Previously treated with at least one chemotherapy regimen.
- The cancer must be c-MET positive, meaning laboratory testing of the tumor shows a moderate to high level of c-MET protein in at least half of the cancer cells.
- At least one tumor can be measured on scans according to standard cancer assessment criteria.
- The participant is generally well enough for daily activities, with an ECOG Performance Status of 0 or 1 (fully active or only restricted in strenuous activities).
- Important organs are functioning adequately, based on blood and laboratory test results, including:
- Normal heart rhythm measurement (QTc interval).
- Women who can become pregnant must have a negative pregnancy test during screening and again shortly before starting study treatment.
- Women who can become pregnant must use an effective birth control method from the first dose of study treatment until 6 months after the last dose.
- Sexually active men must use a barrier method of contraception (such as condoms) during the study and for about 3 months after the last dose. They must also not donate sperm during this period.
Who cannot join
- Cancer has spread to the brain or spinal cord and has not been treated.
- People with previously treated brain metastases may still be eligible if they are stable, have no symptoms, and are not taking steroids for neurological problems.
- They have a serious medical or mental health condition that could make participation unsafe or affect the study results.
- They have previously received radioactive cancer treatments, such as radioembolization (for example, Y-90 treatment).
- They received anti-cancer treatment within the last 4 weeks before starting the study drug.
- They received an experimental (investigational) anti-cancer treatment within the last 4 weeks or within 5 half-lives of that treatment (whichever period is longer).
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- They received radiation therapy too recently, including:
- Radiation to a large area of bone marrow within 6 weeks before study treatment, or
- Radiation to a specific area within 2 weeks before study treatment.
- They had major surgery within the last 6 weeks or have not completely recovered from the surgery and its side effects.
- They are allergic to the study drug or any of its ingredients.
- They are currently participating in another clinical trial that involves treatment or intervention.
- They still have significant side effects from previous cancer treatments.
- People may still be eligible if they have:
- Hair loss of any severity,
- Mild to moderate nerve damage (Grade 2),
- Moderate fatigue (Grade 2),
- Stable diabetes,
- Well-controlled underactive or overactive thyroid disease.
- They have a history of interstitial lung disease (a serious lung condition that causes scarring and inflammation of the lungs).
- They have serious heart disease, including:
- Heart attack within the last 6 months,
- Unstable chest pain (angina),
- Moderate to severe heart failure,
- Uncontrolled high blood pressure,
- Uncontrolled abnormal heart rhythms,
- Severe narrowing of the aortic heart valve.
- They have an active infection that requires treatment, including:
- HIV,
- Hepatitis B,
- Hepatitis C,
- COVID-19 (SARS-CoV-2).
- However, some people with chronic HIV, hepatitis B, or hepatitis C may be allowed to participate if their infection is well controlled and approved by the study doctor.
- They have had another type of active cancer within the last 3 years, apart from the cancer being studied.
- Some exceptions may be allowed if the other cancer is well controlled and does not require treatment during the study.
- They are pregnant or breastfeeding, or plan to become pregnant or donate eggs during the study or within 6 months after the last dose of the study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Full-Life Technologies Investigational Site
Nedlands
Global Study Lead, 6179397858, clinicaltrials@t-full.com
About this study
Official title: A First-in-Human Phase 1/2 Dose Escalation and Treatment Optimization Study Evaluating Safety, Tolerability, and Preliminary Efficacy of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
This is a first-in-human, multicenter, open-label Phase 1/2 study designed to evaluate the safety, efficacy, and tolerability of [225Ac]Ac-FL-261, a targeted radioligand therapy directed at c-MET, in participants with advanced or metastatic solid tumors. Phase 1 will identify the recommended dose through dose escalation, followed by a randomized comparison of two candidate dosing regimens (dose optimization). In Phase 2, the selected dose will be tested in independent cohorts by tumor type.
Read the detailed description
Phase 1: Dose Escalation
[225Ac]Ac-FL-261 will be administered at increasing doses in participants with non-squamous non-small cell lung cancer (ns-NSCLC) to identify the maximum tolerated dose (MTD) based on a BOIN design.
Phase 1 - Dose Optimization
After Dose Escalation is complete, 2 treatment regimens will be compared to select the optimal treatment regimen (OTR) between them.
Phase2
Participants with ns-NSCLC, colorectal cancer, head and neck cancer and cholangiocarcinoma will be enrolled into separate cohorts to estimate the efficacy of [225Ac]Ac-FL-261 at the OTR in each indication.
- Conditions
- Solid Tumor, NSCLC, Colorectal Cancer, Head and Neck Cancer, Cholangiocarcinoma
- Being tested
- [225Ac]Ac-FL-261
- Keywords
- Non small cell lung cancer, metastatic NSCLC, advanced NSCLC, H&N cancer, bile duct cancers, CRC, Phase 1, dose escalation, dose optimization, phase 2
- Medical subject headings
- Colorectal Neoplasms, Head and Neck Neoplasms, Cholangiocarcinoma, Carcinoma, Non-Small-Cell Lung, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[225Ac]Ac-FL-261Drug
Dose escalation per BOIN design to determine MTD.
[225Ac]Ac-FL-261Drug
Two candidate dosing regimens, randomized 1:1 (30 participants per arm)
[225Ac]Ac-FL-261Drug
- Non-squamous non-small cell lung cancer (NSCLC)
- Colorectal cancer (CRC)
- Head and neck squamous cell carcinoma (HNSCC)
- Cholangiocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 - Dose Escalation | Experimental | Dose escalation will use the Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD). Receives: Drug: [225Ac]Ac-FL-261 |
| Phase 1 - Dose Optimization | Experimental | Randomized comparison of two candidate dosing regimens to select the optimal treatment regimen (OTR) for Phase 2. Receives: Drug: [225Ac]Ac-FL-261 |
| Phase 2 | Experimental | The optimal dose and regimen is tested in separate cohorts by tumor type, using a two-stage design. Receives: Drug: [225Ac]Ac-FL-261 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Dose Escalation: Incidence of Dose-Limiting Toxicities (DLTs)
Measured: Until 28 days after the first injection of [225Ac]Ac-FL-261]
2. Phase 1 Dose Escalation and Phase 1 Dose Optimization: Type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0
Measured: From ICF signature and up to 35 days after the last dose of study treatment for all AEs/SAEs. Thereafter, only AEs of special interest (AESIs) and related SAEs will be reported (up to 5 years)
Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 5 years)
Secondary outcomes (9)
Phase 1 and Phase 2: Duration of response (DoR)
Measured: Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)
Phase 1 and Phase 2: Disease control rate (DCR)
Measured: Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)]
Phase 1 and Phase 2: Progression-free survival (PFS) by RECIST v1.1
Measured: Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)
Phase 1 and Phase 2: Overall survival (OS)
Measured: Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)
Phase 1: ORR by RECIST v1.1
Measured: Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)
Phase 1 and Phase 2: Peak plasma concentration (Cmax) of [225Ac]Ac-FL-261
Measured: Phase 1: Up to Day 15 of Cycle 1 and Cycle 2 (each cycle is 28 days); and on the first day of Cycle 3 and Cycle 4. Phase 2: Up to Day 15 of Cycle 1
Phase 1 and Phase 2: Time to achieve Cmax (tmax)
Measured: Phase 1: Up to Day 15 of Cycle 1 and Cycle 2; and on the first day of Cycle 3 and Cycle 4. Phase 2: Up to Day 15 of Cycle 1
Phase 1 and Phase 2: Area under the plasma concentration-time curve (AUC)
Measured: Phase 1: Up to Day 15 of Cycle 1 and Cycle 2; and on the first day of Cycle 3 and Cycle 4. Phase 2: Up to Day 15 of Cycle 1
Phase 2: Type, frequency, and severity of AEs and SAEs using NCI CTCAE v6.0.
Measured: From ICF signature and up to 35 days after the last dose of study treatment for all AEs/SAEs. Thereafter, only AESIs and related SAEs will be reported (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Full-Life Technologies UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873450
- Sponsor's protocol ID
- FL-261-001
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Phase 1/2 Dose Escalation and Treatment Optimization Study Evaluating Safety, Tolerability, and Preliminary Efficacy of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
- ClinicalTrials.gov ID
- NCT07873450
- Acronym / sponsor ID
- FL-261-001
- Conditions
- Solid Tumor, NSCLC, Colorectal Cancer, Head and Neck Cancer, Cholangiocarcinoma
- Keywords
- Non small cell lung cancer, metastatic NSCLC, advanced NSCLC, H&N cancer, bile duct cancers, CRC, Phase 1, dose escalation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Full-Life Technologies UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 14 Oct 2026 (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, multicenter, open-label Phase 1/2 study designed to evaluate the safety, efficacy, and tolerability of [225Ac]Ac-FL-261, a targeted radioligand therapy directed at c-MET, in participants with advanced or metastatic solid tumors. Phase 1 will identify the recommended dose through dose escalation, followed by a randomized comparison of two candidate dosing regimens (dose optimization). In Phase 2, the selected dose will be tested in independent cohorts by tumor type.
Detailed description
Phase 1: Dose Escalation
[225Ac]Ac-FL-261 will be administered at increasing doses in participants with non-squamous non-small cell lung cancer (ns-NSCLC) to identify the maximum tolerated dose (MTD) based on a BOIN design.
Phase 1 - Dose Optimization
After Dose Escalation is complete, 2 treatment regimens will be compared to select the optimal treatment regimen (OTR) between them.
Phase2
Participants with ns-NSCLC, colorectal cancer, head and neck cancer and cholangiocarcinoma will be enrolled into separate cohorts to estimate the efficacy of [225Ac]Ac-FL-261 at the OTR in each indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - Dose Escalation | Experimental | Drug: [225Ac]Ac-FL-261Dose escalation will use the Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD). |
| Phase 1 - Dose Optimization | Experimental | Drug: [225Ac]Ac-FL-261Randomized comparison of two candidate dosing regimens to select the optimal treatment regimen (OTR) for Phase 2. |
| Phase 2 | Experimental | Drug: [225Ac]Ac-FL-261The optimal dose and regimen is tested in separate cohorts by tumor type, using a two-stage design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- They have signed the consent form before any study-related tests or procedures are done and are willing to follow all study requirements.
- They are 18 years of age or older.
- They have a confirmed diagnosis of an advanced or metastatic cancer that cannot be cured with surgery, radiation, or other treatments.
- Phase 1: Non-squamous non-small cell lung cancer (ns-NSCLC).
- Phase 2: Non-squamous non-small cell lung cancer (ns-NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), or cholangiocarcinoma (bile duct cancer).
Key exclusion criteria (36 listed)
- Cancer has spread to the brain or spinal cord and has not been treated.
- People with previously treated brain metastases may still be eligible if they are stable, have no symptoms, and are not taking steroids for neurological problems.
- They have a serious medical or mental health condition that could make participation unsafe or affect the study results.
- They have previously received radioactive cancer treatments, such as radioembolization (for example, Y-90 treatment).
- They received anti-cancer treatment within the last 4 weeks before starting the study drug.
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 |
|---|---|---|
| [225Ac]Ac-FL-261Dose escalation per BOIN design to determine MTD. | Drug | Phase 1 - Dose Escalation |
| [225Ac]Ac-FL-261Two candidate dosing regimens, randomized 1:1 (30 participants per arm) | Drug | Phase 1 - Dose Optimization |
| [225Ac]Ac-FL-261* Non-squamous non-small cell lung cancer (NSCLC) * Colorectal cancer (CRC) * Head and neck squamous cell carcinoma (HNSCC) * Cholangiocarcinoma | Drug | Phase 2 |
Primary outcome
Phase 1 Dose Escalation: Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Until 28 days after the first injection of [225Ac]Ac-FL-261]
2. Phase 1 Dose Escalation and Phase 1 Dose Optimization: Type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0
Time frame: From ICF signature and up to 35 days after the last dose of study treatment for all AEs/SAEs. Thereafter, only AEs of special interest (AESIs) and related SAEs will be reported (up to 5 years)
Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 5 years)
9 secondary outcomes
Phase 1 and Phase 2: Duration of response (DoR)
Time frame: Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)
Phase 1 and Phase 2: Disease control rate (DCR)
Time frame: Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)]
Phase 1 and Phase 2: Progression-free survival (PFS) by RECIST v1.1
Time frame: Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)
Phase 1 and Phase 2: Overall survival (OS)
Time frame: Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)
Phase 1: ORR by RECIST v1.1
Time frame: Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)
Phase 1 and Phase 2: Peak plasma concentration (Cmax) of [225Ac]Ac-FL-261
Time frame: Phase 1: Up to Day 15 of Cycle 1 and Cycle 2 (each cycle is 28 days); and on the first day of Cycle 3 and Cycle 4. Phase 2: Up to Day 15 of Cycle 1
Phase 1 and Phase 2: Time to achieve Cmax (tmax)
Time frame: Phase 1: Up to Day 15 of Cycle 1 and Cycle 2; and on the first day of Cycle 3 and Cycle 4. Phase 2: Up to Day 15 of Cycle 1
Phase 1 and Phase 2: Area under the plasma concentration-time curve (AUC)
Time frame: Phase 1: Up to Day 15 of Cycle 1 and Cycle 2; and on the first day of Cycle 3 and Cycle 4. Phase 2: Up to Day 15 of Cycle 1
Phase 2: Type, frequency, and severity of AEs and SAEs using NCI CTCAE v6.0.
Time frame: From ICF signature and up to 35 days after the last dose of study treatment for all AEs/SAEs. Thereafter, only AESIs and related SAEs will be reported (up to 5 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 16 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [225Ac]Ac-FL-261 in people with Solid Tumor and NSCLC, run by Full-Life Technologies UK Limited at 1 site in Australia.
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 18 inclusion and 36 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 Full-Life Technologies (617-939-7858, clinicaltrials@t-full.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Dose Escalation: Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Until 28 days after the first injection of [225Ac]Ac-FL-261]). The study lists 3 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 16 Oct 2026.