RecruitingPhase 1

A Study of SKB107 in Advanced Solid Tumors With Bone Metastases

China90 participantsStarted 2025-08-15

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. 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;

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Timeframe: Up to 3 year

Trial details

NCT IDNCT07087197

SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-01

Contact for this trial

Yina Diao

028-67252634 diaoyina@kelun.com

View on ClinicalTrials.gov More Metastatic Solid Tumors trials