Metastatic Solid TumorsPhase 1NCT07087197
A Study of SKB107 in Advanced Solid Tumors With Bone Metastases
A Phase 1 study testing SKB107 for injection in people with Metastatic Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of SKB107 in subjects with advanced solid tumors with bone metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Solid Tumors
- What is being tested?
- SKB107 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 1 Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age should be between 18 years and 75 years at the time of signing the informed consent form (ICF);
- The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;
- The expected survival period should be ≥ 3 months;
- Phase Ia: Subjects with advanced solid tumor bone metastases diagnosed by histology or cytology; and the subjects have failed standard treatment, or have no standard treatment, or are intolerant or not applicable to standard treatment;
- Phase Ib: Subjects with advanced mCRPC diagnosed by histology or cytology;
- Before the first administration, a 99mTc-MDP bone scan diagnosed multiple bone metastases, and at least one site was confirmed by CT or MRI;
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- Have adequate organ and bone marrow functions;
- For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration;
- The subjects voluntarily join this study, sign the informed consent form, and can comply with the visit and related procedures stipulated in the protocol.
Who cannot join
- The washout period before the first administration of the study drug was insufficient.
- Previous received similar radionuclide internal irradiation treatment.
- Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.
- Known "super bone imaging".
- Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.
- Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug.
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- Poorly controlled diabetes and hypertension.
- The toxicity of previous anti-tumor treatment before the first administration has not recovered to ≤ 1 grade (evaluated based on NCI-CTCAE v5.0) or has not reached the level specified in the inclusion/exclusion criteria.
- Had other malignant tumors within 3 years before the first administration.
- Subjects with severe and/or uncontrolled concomitant diseases.
- Active hepatitis B or active hepatitis C.
- Human immunodeficiency virus (HIV) test positive or having a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection.
- Subjects with a history of radionuclide/radioactive drug allergy, or allergic to any component of the study formulation.
- During the screening process before the first administration, the condition deteriorated rapidly, such as significant changes in the investigator's assessment of physical condition, etc.
- Subjects participating in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an intervention study.
- Any unstable disease or clinical condition, or any condition that may endanger the safety of the subject or affect the subject's compliance, or any other conditions that the investigator deems inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Ding-Wei Ye, Proferssor, 021-64175590, dwyeli@163.com
Shao-Li Song, Professor, 021-34778299, Shaoli-song@163.com
About this study
Official title: A Multicenter, Open-label Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Dosimetry and Efficacy of SKB107 in Subjects With Advanced Solid Tumors With Bone Metastases
A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of SKB107 in subjects with advanced solid tumors with bone metastases.
Read the detailed description
This study is a multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of SKB107 in subjects with advanced solid tumors with bone metastases. The study is divided into two parts: Phase Ia and Phase Ib. The Phase Ia study is the dose escalation phase. The primary objective is to assess the safety and tolerability of a single administration of SKB107 and to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) based on the occurrence of Dose-Limiting Toxicities (DLTs) associated with SKB107 (if the MTD cannot be determined).The Phase Ib study is the dose expansion phase. The primary objective is to explore the optimal dose, safety, or efficacy of SKB107 at a selected dose level (confirmed as safe by the Safety Review Committee (SRC) and not exceeding the MTD or MAD)
- Conditions
- Metastatic Solid Tumors
- Being tested
- SKB107 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB107 for injectionDrug
177Lu-DOTA-IBA is a Radionuclide conjugated drugs (RDC) targeting bone.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a：Dose escalation | Experimental | 5 dose levels are tentatively planned for Phase 1a Receives: Drug: SKB107 for injection |
| Phase 1b: Dose expansion | Experimental | The dose of SKB107 for injection in Phase 1b is selected based on the Phase 1a monotherapy dose escalation study Receives: Drug: SKB107 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Up to 3 year
Secondary outcomes (6)
Maximum plasma concentration (Cmax) of SKB107
Measured: Up to 1 week
Dosimetry
To collec the biological distribution of major tissues/organs.
Measured: Up to 1 week
Time to Radiographic Bone Progresion (TTRBP)
Time from start of treatment to progression of bone lesion (PD) or death, whichever occurs first, during the study period
Measured: Through study completion, an average of 1 year.
Radiographic progression-free survival (rPFS)
Time from start of treatment to progression of Disease (PD) or death, whichever occurs first
Measured: Through study completion, an average of 1 year
Overall survival(OS)
Time from start of treatment to death due to any reason
Measured: Up to 3 years
symptomatic skeletal event-free survival (SSE-FS)
Time from start of treatment to the first occurrence of new SSE or death from any cause , whichever occurs first.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start15 Aug 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Jul 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.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087197
- Sponsor's protocol ID
- SKB107-I-01
- Status last verified
- May 2026
- First submitted
- 30 Jun 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Dosimetry and Efficacy of SKB107 in Subjects With Advanced Solid Tumors With Bone Metastases
- ClinicalTrials.gov ID
- NCT07087197
- Acronym / sponsor ID
- SKB107-I-01
- Conditions
- Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 25 Jul 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.
A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of SKB107 in subjects with advanced solid tumors with bone metastases.
Detailed description
This study is a multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of SKB107 in subjects with advanced solid tumors with bone metastases. The study is divided into two parts: Phase Ia and Phase Ib. The Phase Ia study is the dose escalation phase. The primary objective is to assess the safety and tolerability of a single administration of SKB107 and to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) based on the occurrence of Dose-Limiting Toxicities (DLTs) associated with SKB107 (if the MTD cannot be determined).The Phase Ib study is the dose expansion phase. The primary objective is to explore the optimal dose, safety, or efficacy of SKB107 at a selected dose level (confirmed as safe by the Safety Review Committee (SRC) and not exceeding the MTD or MAD)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a：Dose escalation | Experimental | Drug: SKB107 for injection5 dose levels are tentatively planned for Phase 1a |
| Phase 1b: Dose expansion | Experimental | Drug: SKB107 for injectionThe dose of SKB107 for injection in Phase 1b is selected based on the Phase 1a monotherapy dose escalation study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The age should be between 18 years and 75 years at the time of signing the informed consent form (ICF);
- The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;
- The expected survival period should be ≥ 3 months;
- Phase Ia: Subjects with advanced solid tumor bone metastases diagnosed by histology or cytology; and the subjects have failed standard treatment, or have no standard treatment, or are intolerant or not applicable to standard treatment;
- Phase Ib: Subjects with advanced mCRPC diagnosed by histology or cytology;
Key exclusion criteria (16 listed)
- The washout period before the first administration of the study drug was insufficient.
- Previous received similar radionuclide internal irradiation treatment.
- Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.
- Known "super bone imaging".
- Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.
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 |
|---|---|---|
| SKB107 for injection177Lu-DOTA-IBA is a Radionuclide conjugated drugs (RDC) targeting bone. | Drug | Phase 1a：Dose escalation, Phase 1b: Dose expansion |
Primary outcome
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Up to 3 year
6 secondary outcomes
Maximum plasma concentration (Cmax) of SKB107
Time frame: Up to 1 week
Dosimetry
Time frame: Up to 1 week
Time to Radiographic Bone Progresion (TTRBP)
Time frame: Through study completion, an average of 1 year.
Radiographic progression-free survival (rPFS)
Time frame: Through study completion, an average of 1 year
Overall survival(OS)
Time frame: Up to 3 years
symptomatic skeletal event-free survival (SSE-FS)
Time frame: Up to 3 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 8 May 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 study testing SKB107 for injection in people with Metastatic Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
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 9 inclusion and 16 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 8 May 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 China. 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 Yina Diao (028-67252634, diaoyina@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. (time frame: Up to 3 year). 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 8 May 2026.