A Study of SKB107 in Advanced Solid Tumors With Bone Metastases

NCT07087197 | Recruiting Phase 1

• 1 other identifier: SKB107-I-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

  Up to 3 year

Secondary Outcomes (6)

• Maximum plasma concentration (Cmax) of SKB107

  Up to 1 week

• Dosimetry

  Up to 1 week

• Time to Radiographic Bone Progresion (TTRBP)

  Through study completion, an average of 1 year.

• Radiographic progression-free survival (rPFS)

  Through study completion, an average of 1 year

• Overall survival(OS)

  Up to 3 years

Study Arms (2)

Phase 1a：Dose escalation

EXPERIMENTAL

5 dose levels are tentatively planned for Phase 1a

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

Drug: SKB107 for injection

Interventions

SKB107 for injection DRUG

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

Phase 1a：Dose escalation; Phase 1b: Dose expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• The subjects voluntarily join this study, sign the informed consent form, and can comply with the visit and related procedures stipulated in the protocol.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yina Diao

CONTACT

028-67252634; diaoyina@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 25, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CN (1)