A Study of SKB107 in Advanced Solid Tumors With Bone Metastases

NCT ID: NCT07087197

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2028-07-01

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1a：Dose escalation

5 dose levels are tentatively planned for Phase 1a

Group Type: EXPERIMENTAL

SKB107 for injection

Intervention Type: DRUG

177Lu-DOTA-IBA is a Radionuclide conjugated drugs (RDC) targeting bone.

Phase 1b: Dose expansion

The dose of SKB107 for injection in Phase 1b is selected based on the Phase 1a monotherapy dose escalation study

Group Type: EXPERIMENTAL

SKB107 for injection

Intervention Type: DRUG

177Lu-DOTA-IBA is a Radionuclide conjugated drugs (RDC) targeting bone.

Interventions

SKB107 for injection

177Lu-DOTA-IBA is a Radionuclide conjugated drugs (RDC) targeting bone.

Intervention Type: DRUG

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yina Diao

Role: CONTACT

diaoyina@kelun.com

028-67252634

Facility Contacts

Ding-Wei Ye, Proferssor

Role: primary

dwyeli@163.com

021-64175590

Shao-Li Song, Professor

Role: backup

Shaoli-song@163.com

021-34778299

Other Identifiers

SKB107-I-01

Identifier Type: -

Identifier Source: org_study_id