SKB107 for advanced solid tumors that have spread to bone

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

This trial will test SKB107 in adults whose solid tumors have metastasized to bone to see if the drug is safe, how it behaves in the body, and whether it shows signs of benefit.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07087197 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter Phase I trial with a dose-escalation Phase Ia and a dose-expansion Phase Ib. Phase Ia uses single-administration dose escalation to identify the maximum tolerated or maximum administered dose based on dose-limiting toxicities, with safety, tolerability, pharmacokinetics, and dosimetry as primary endpoints. Phase Ib expands at a selected safe dose to further evaluate safety and preliminary efficacy, with enrollment focused on metastatic castration-resistant prostate cancer in the expansion cohort. Eligible patients must have confirmed bone metastases by 99mTc-MDP bone scan plus CT or MRI, ECOG performance status 0-1, adequate organ and marrow function, and have exhausted or be ineligible for standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults (18–75) with advanced solid tumors and confirmed bone metastases who have ECOG ≤1, adequate organ/bone marrow function, expected survival ≥3 months, and have failed or are ineligible for standard therapies; the Phase Ib cohort focuses on mCRPC.

Not a fit: Patients without bone metastases, with poor performance status (ECOG >1), significant organ dysfunction, life expectancy under three months, or those who are still benefiting from standard therapies are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, SKB107 could provide a new therapeutic option that targets bone metastases and helps patients who have limited standard treatment choices.

How similar studies have performed: Radiopharmaceuticals and bone-targeted agents (for example, radium-223) have shown benefit in bone-metastatic disease, but SKB107 itself is a novel early-phase agent and requires clinical testing to establish its effects.

Eligibility criteria

Inclusion Criteria:

1. The age should be between 18 years and 75 years at the time of signing the informed consent form (ICF);
2. The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;
3. The expected survival period should be ≥ 3 months;
4. 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;
5. Phase Ib: Subjects with advanced mCRPC diagnosed by histology or cytology;
6. Before the first administration, a 99mTc-MDP bone scan diagnosed multiple bone metastases, and at least one site was confirmed by CT or MRI;
7. Have adequate organ and bone marrow functions;
8. For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration;
9. The subjects voluntarily join this study, sign the informed consent form, and can comply with the visit and related procedures stipulated in the protocol.

Exclusion Criteria:

1. The washout period before the first administration of the study drug was insufficient.
2. Previous received similar radionuclide internal irradiation treatment.
3. Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.
4. Known "super bone imaging".
5. Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.
6. Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug.
7. Poorly controlled diabetes and hypertension.
8. 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.
9. Had other malignant tumors within 3 years before the first administration.
10. Subjects with severe and/or uncontrolled concomitant diseases.
11. Active hepatitis B or active hepatitis C.
12. Human immunodeficiency virus (HIV) test positive or having a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection.
13. Subjects with a history of radionuclide/radioactive drug allergy, or allergic to any component of the study formulation.
14. 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.
15. Subjects participating in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an intervention study.
16. 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.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yina Diao

Conditions Metastatic Solid Tumors