A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors

NCT06736327 | Recruiting Phase 1

• 1 other identifier: SKB500-Ⅰ-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Evaluate the incidence of adverse events (AEs)

  Up to 3 years

• Evaluate the incidence of serious adverse events (SAEs)

  Up to 3 years

• Evaluate the incidence of treatment related adverse events (TRAEs)

  Up to 3 years

• Evaluate the incidence of dose-limiting toxicities (DLTs)

  Day 1 to Day 21 in Cycle 1 in the dose escalation part

Secondary Outcomes (9)

• Investigate the antitumor activity of SKB500

  Up to 3 years

• To evaluate the Tmax of SKB500

  Up to 3 years

• To evaluate the Cmax of SKB500

  Up to 3 years

• To evaluate the Cmin of SKB500

  Up to 3 years

• To evaluate the AUC of SKB500

  Up to 3 years

Other Outcomes (1)

• To evaluate the relationship between the biomarker and the antitumor activity

  Up to 3 years

Study Arms (1)

SKB500

EXPERIMENTAL

Subjects will receive SKB500 once every three weeks (Q3W).

Drug: SKB500

Interventions

SKB500 DRUG

The administration route of SKB500 is intravenous infusion, with a dosing frequency of Q3W.

SKB500

Eligibility Criteria

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

You may qualify if:

• Male or female participants between 18 and 75 years old.
• Histologically or cytologically confirmed advanced solid tumors for which standard treatment either does not exist or has proven ineffective or intolerable.
• Subjects should ideally provide a tumor tissue sample for biomarker testing during the screening period.
• Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
• ECOG performance status score of 0 or 1.
• Expected survival of at least 12 weeks.
• Has adequate hematopoietic, renal and hepatic functions.
• Have recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.
• Male and female subjects must agree to use highly effective contraceptive methods throughout the study.
• Subjects must voluntarily enter the study, sign the informed consent form, and be able to comply with the visits and procedures.

You may not qualify if:

• Subjects with known active CNS metastases, carcinomatous meningitis, leptomeningeal metastases, or spinal cord compression.
• Subjects with other malignancies within 5 years before the first dose.
• Any severe and/or uncontrolled concurrent disease that may interfere with the subject's participation in the study.
• Active hepatitis B, or hepatitis C; active tuberculosis, or human immunodeficiency virus (HIV) test positive, or known acquired immunodeficiency syndrome (AIDS).
• History of allergy to any component of SKB500 or history of severe hypersensitivity reactions to other monoclonal antibodies.
• Subjects with a history of interstitial lung disease, non-infectious pneumonia, or other pulmonary diseases significantly affecting lung function.
• History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
• Uncontrolled pleural effusion, ascites, or pericardial effusion.
• Have received ADCs with the same target or the same toxins.
• Have received chemotherapy, small molecule targeted therapy, and traditional Chinese medicine preparations within 14 days or 5 half-lives before the first dose; have received any immunotherapy, large molecule anticancer drug treatment, or more than 30% bone marrow radiation or extensive radiotherapy within 28 days before the first dose.
• Have undergone major surgery or severe trauma within 28 days before the first dose.
• Have received other clinical trial medications within 28 days before the first dose.
• Has previously received anti-cancer or live vaccines within 28 days before the first dose
• Have received systemic steroids or other immunosuppressive treatments within 14 days before the first dose.
• Have received potent CYP3A4 inhibitors, inducers, or BCRP inhibitors within 14 days or 5 half-lives before the first dose.

Sponsors & Collaborators

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

Study Sites (1)

JILIN Cancer Hospital

Jilin, China

RECRUITING

Central Study Contacts

Yan Qing

CONTACT

028-67255480; qingyan@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 16, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CN (1)