Metastatic Solid TumorsPhase 1NCT07728942
SLR-108 PET Imaging in Subjects With Metastatic Solid Tumors
A Phase 1 study testing SLR-108 and SLX-1411 in people with Metastatic Solid Tumors, run by Solve Therapeutics at 1 site in United States.
Trial summary
This is a Phase 1 study evaluating the feasibility of using SLR-108 for positron-emission tomography (PET) imaging of metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumors
- What is being tested?
- SLR-108 and SLX-1411
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to Feb 2028
- Phase
- Phase 1
- 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
- Men or women (as appropriate for cancer type) of age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records.
- Based on the most recent tumor assessment, presence of metastatic disease that has progressed during or following previous treatment.
- Presence of radiographically measurable disease (defined as the presence of ≥1 non-osseous tumor lesion that measures ≥10 mm in longest dimension [≥15 mm in shortest dimension for lymph nodes] and is outside of any prior radiation field).
- Prior receipt of commercially available therapies that are indicated for the subject's cancer and have a demonstrated survival benefit for that indication.
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- Availability of tumor tissue from fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival sample from a previous biopsy.
- Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before study drug administration.
- Adequate hematological profile.
- Adequate coagulation profile.
- Adequate hepatic profile.
- Adequate renal function.
- Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection.
- For female subjects of childbearing potential, a negative serum pregnancy test.
- For female subjects of childbearing potential, willingness to use a protocol recommended method of contraception from the start of the screening period until ≥6 months after study drug administration.
- For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol recommended method of contraception from the start and until ≥6 months after study drug administration and to refrain from sperm donation from the start and until ≥12 months after study drug administration.
- Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including any required tumor biopsy/aspirations and all radiographic studies), and study restrictions.
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the study drug, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
Who cannot join
- Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4 weeks, and do not require corticosteroids.
- Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.
- Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of study drug administration.
- Significant cardiovascular event or comorbidity.
- Significant screening ECG abnormalities.
- Pregnancy or breastfeeding.
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- Any medical condition preventing PET/CT scanning, and/or inability to tolerate up to 60 minutes of PET/CT scanning per imaging session, and/or ineligibility for PET/CT scanning due to the weight limits of the scanner.
- Major surgery within 4 weeks before study drug administration.
- Use of a drug known to prolong the QT interval within 7 days prior to study drug administration.
- Anticipated use of a strong inhibitor or inducer of cytochrome CYP3A4 or CYP1A2.
- Concurrent participation in another therapeutic or imaging clinical trial.
- Any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Hoag Molecular Imaging and Therapy, 949-557-0285, MIT@hoag.org
About this study
Official title: A Phase 1 Study of the Antibody-Radionuclide Conjugate SLR-108 for Positron Emission Tomography Imaging in Subjects With Metastatic Solid Tumors
This is a Phase 1 study evaluating the feasibility of using SLR-108 for positron-emission tomography (PET) imaging of metastatic solid tumors.
Read the detailed description
This study will assess the safety, pharmacokinetics, biodistribution, radiation dosimetry, and image quality of a single IV injection of the diagnostic radiopharmaceutical SLR-108, evaluating a range of antibody protein dose levels and radioactivity dose levels in subjects with metastatic solid tumors. PET imaging will be performed following administration of SLR-108.
- Conditions
- Metastatic Solid Tumors
- Being tested
- SLR-108, SLX-1411
- Keywords
- metastatic solid tumors, metastatic cancer, solid tumor, positron-emission tomography, PET
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLR-108Drug
SLR-108 is an antibody-radionuclide conjugate.
SLX-1411Drug
SLX-1411 is a non-radiolabeled antibody.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1 | Experimental | Low total antibody dose, initial radioactivity dose Receives: Drug: SLR-108; Drug: SLX-1411 |
| Part 1: Cohort 2 | Experimental | Medium total antibody dose, initial radioactivity dose Receives: Drug: SLR-108; Drug: SLX-1411 |
| Part 1: Cohort 3 | Experimental | High total antibody dose, initial radioactivity dose Receives: Drug: SLR-108; Drug: SLX-1411 |
| Part 2 | Experimental | TBD total antibody dose, lower TBD radioactivity dose Receives: Drug: SLR-108; Drug: SLX-1411 |
| Part 3 | Experimental | TBD total antibody dose, TBD radioactivity dose Receives: Drug: SLR-108; Drug: SLX-1411 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal antibody protein dose
The appropriate antibody dose (in mg) for optimal imaging
Measured: Through Day 14
Optimal administered activity
The appropriate radioactivity dose (in mCi) for optimal imaging
Measured: Through Day 14
Optimal SLR-108 PET timing
The optimal timing of PET imaging for differentiating tumor tissue from normal background tissue
Measured: Through Day 14
Secondary outcomes (13)
Study drug administration
Duration of study drug administration (in minutes) as assessed by radiopharmacy and clinical records
Measured: Through Day 0
Study drug safety
Type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events (TEAEs); laboratory abnormalities; dose-limiting toxicities (DLTs); serious adverse events (SAEs); adverse events of special interest (AESIs); or AEs leading to interruption or modification of study drug administration.
Measured: Through Day 14
Supportive care profile
Number of subjects receiving supportive care and other concomitant medications
Measured: Through Day 14
Study drug pharmacokinetics - Cmax
Study drug maximum plasma concentration (Cmax)
Measured: Through Day 14
Study drug pharmacokinetics - AUC
Study drug area under the concentration-time curve (AUC)
Measured: Through Day 14
Study drug pharmacokinetics - t1/2
Study drug half-life (t1/2)
Measured: Through Day 14
Image Quality
Image quality scores as assessed based on SLR-108 PET
Measured: Through Day 14
PET tumor lesion identification
Numbers and organ locations of tumor lesions based on tumor-to-background score as assessed qualitatively on SLR-108 PET
Measured: Through Day 14
CT tumor lesion identification
Numbers and organ locations of tumor lesions as assessed by concomitant CT imaging
Measured: Through Day 14
Biodistribution
Whole-body radioactivity clearance as assessed by PET
Measured: Through Day 14
Normal tissue radiation dosimetry
Standardized uptake values (SUVs) for normal tissues as assessed by PET
Measured: Through Day 14
Tumor tissue radiation dosimetry
SUVs for tumor lesions as assessed by PET
Measured: Through Day 14
Immunogenicity
Circulating anti-drug antibodies as assessed by immunoassay
Measured: Through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start4 Aug 2026
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorsStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In Part 1, groups of participants will receive sequentially escalating doses of total antibody protein dose and an initial radioactivity dose. Sequential PET scans will be performed to determine the optimal antibody protein dose and scan schedule. In Part 2, a lower radioactivity dose will be evaluated in a further cohort if justified by the image quality in Part 1. The total antibody protein dose to be assessed in Part 2 will be selected based on the information collected in Part 1. In Part 3, additional subjects will be enrolled in a confirmatory expansion cohort to evaluate the optimal antibody protein dose and radioactivity dose and a single-timepoint PET schedule as determined in the previous parts of this study.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solve Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728942
- Sponsor's protocol ID
- SLR-108-01Dx
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: A clinical study report will be written and study results will be published. Sharing of individual participant data with other researchers is not planned.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Antibody-Radionuclide Conjugate SLR-108 for Positron Emission Tomography Imaging in Subjects With Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07728942
- Acronym / sponsor ID
- SLR-108-01Dx
- Conditions
- Metastatic Solid Tumors
- Keywords
- metastatic solid tumors, metastatic cancer, solid tumor, positron-emission tomography, PET
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Solve TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 27 Jul 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 Phase 1 study evaluating the feasibility of using SLR-108 for positron-emission tomography (PET) imaging of metastatic solid tumors.
Detailed description
This study will assess the safety, pharmacokinetics, biodistribution, radiation dosimetry, and image quality of a single IV injection of the diagnostic radiopharmaceutical SLR-108, evaluating a range of antibody protein dose levels and radioactivity dose levels in subjects with metastatic solid tumors. PET imaging will be performed following administration of SLR-108.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- In Part 1, groups of participants will receive sequentially escalating doses of total antibody protein dose and an initial radioactivity dose. Sequential PET scans will be performed to determine the optimal antibody protein dose and scan schedule. In Part 2, a lower radioactivity dose will be evaluated in a further cohort if justified by the image quality in Part 1. The total antibody protein dose to be assessed in Part 2 will be selected based on the information collected in Part 1. In Part 3, additional subjects will be enrolled in a confirmatory expansion cohort to evaluate the optimal antibody protein dose and radioactivity dose and a single-timepoint PET schedule as determined in the previous parts of this study.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1 | Experimental | Drug: SLR-108, Drug: SLX-1411Low total antibody dose, initial radioactivity dose |
| Part 1: Cohort 2 | Experimental | Drug: SLR-108, Drug: SLX-1411Medium total antibody dose, initial radioactivity dose |
| Part 1: Cohort 3 | Experimental | Drug: SLR-108, Drug: SLX-1411High total antibody dose, initial radioactivity dose |
| Part 2 | Experimental | Drug: SLR-108, Drug: SLX-1411TBD total antibody dose, lower TBD radioactivity dose |
| Part 3 | Experimental | Drug: SLR-108, Drug: SLX-1411TBD total antibody dose, TBD radioactivity dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men or women (as appropriate for cancer type) of age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records.
- Based on the most recent tumor assessment, presence of metastatic disease that has progressed during or following previous treatment.
- Presence of radiographically measurable disease (defined as the presence of ≥1 non-osseous tumor lesion that measures ≥10 mm in longest dimension [≥15 mm in shortest dimension for lymph nodes] and is outside of any prior radiation field).
Key exclusion criteria (12 listed)
- Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4 weeks, and do not require corticosteroids.
- Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.
- Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of study drug administration.
- Significant cardiovascular event or comorbidity.
- Significant screening ECG abnormalities.
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 |
|---|---|---|
| SLR-108SLR-108 is an antibody-radionuclide conjugate. | Drug | Part 1: Cohort 1, Part 1: Cohort 2, Part 1: Cohort 3, Part 2, Part 3 |
| SLX-1411SLX-1411 is a non-radiolabeled antibody. | Drug | Part 1: Cohort 1, Part 1: Cohort 2, Part 1: Cohort 3, Part 2, Part 3 |
Primary outcome
Optimal antibody protein dose
Time frame: Through Day 14
The appropriate antibody dose (in mg) for optimal imaging
Optimal administered activity
Time frame: Through Day 14
The appropriate radioactivity dose (in mCi) for optimal imaging
Optimal SLR-108 PET timing
Time frame: Through Day 14
The optimal timing of PET imaging for differentiating tumor tissue from normal background tissue
13 secondary outcomes
Study drug administration
Time frame: Through Day 0
Study drug safety
Time frame: Through Day 14
Supportive care profile
Time frame: Through Day 14
Study drug pharmacokinetics - Cmax
Time frame: Through Day 14
Study drug pharmacokinetics - AUC
Time frame: Through Day 14
Study drug pharmacokinetics - t1/2
Time frame: Through Day 14
Image Quality
Time frame: Through Day 14
PET tumor lesion identification
Time frame: Through Day 14
CT tumor lesion identification
Time frame: Through Day 14
Biodistribution
Time frame: Through Day 14
Normal tissue radiation dosimetry
Time frame: Through Day 14
Tumor tissue radiation dosimetry
Time frame: Through Day 14
Immunogenicity
Time frame: Through Day 14
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 10 Aug 2026.
- Individual participant dataSharing planned: No. A clinical study report will be written and study results will be published. Sharing of individual participant data with other researchers is not planned.
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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 study testing SLR-108 and SLX-1411 in people with Metastatic Solid Tumors, run by Solve Therapeutics at 1 site in United States.
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 12 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 10 Aug 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 United States. 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 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.
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 Kristina Zakurdaeva, MD, PhD (415-370-3044, KZakurdaeva@solvetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal antibody protein dose (time frame: Through Day 14). 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 10 Aug 2026.