SKB410 for Injection in Solid Tumors

NCT05906537 | Active Not Recruiting Phase 1

• 1 other identifier: SKB410-I-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB410 for injection in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of subjects achieving Dose-limiting toxicity (DLT)

  DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.

  From data of initial dose until up to 28 days for treatment

• Maximum Tolerated Dose (MTD)

  MTD refers to the highest dose at which the subject's DLT incidence meets the EWOC principle (probability of DLT incidence exceeding 33% is less than 25%) during the DLT observation period.

  From data of initial dose until up to 28 days for treatment

Other Outcomes (5)

• ORR

  through study completion, an average of 2 years

• DCR

  through study completion, an average of 2 years

• DOR

  through study completion, an average of 2 years

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Several dose levels are planned in the study and administered every 2 weeks.

Drug: SKB410 for injection

Interventions

SKB410 for injection DRUG

SKB410 for injection is administered every 2 weeks (q2w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Dose Escalation

Eligibility Criteria

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

You may qualify if:

• At the time of signing the ICF: age ≥ 18 years, male or female.
• Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
• Expected survival ≥ 3 months.
• Subjects with adequate organ and bone marrow function confirmed by laboratory results within 3 days prior to the first dose.
• Subjects of childbearing potential (male or female) must use effective medical contraception during the study and continue contraception until 210 days after the last dose for female subjects and until 120 days after the last dose for male subjects.
• Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

You may not qualify if:

• Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter).
• Has received radiotherapy within 4 weeks prior to the first dose.
• Has had major surgery within 4 weeks prior to the first dose.
• Has received strong cytochrome P450 (CYP3A4) inhibitors or inducers (see Annex 4) within 2 weeks prior to the first dose or within 5 half-lives of known drug, whichever is longer.
• Has not recovered to normal or ≤ Grade 1 from any AE and/or complication due to any prior therapy (except alopecia or pigmentation).
• Has known history of allergy to any component of SKB410 or other monoclonal antibodies.
• Has a known previous or concurrent other malignancies within 5 years prior to signing the ICF.
• Presence of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has active autoimmune disease with systemic therapy or immunosuppressive therapy within 2 years prior to signing the ICF.
• Has uncontrolled or severe cardiovascular disease.
• Has uncontrolled systemic diseases.
• Presence of clear neurological or psychiatric disorder.
• Has active infection requiring systemic.
• Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis.
• Pregnant or lactating.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 18, 2023
• Study Start: July 6, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

CN (1)