SKB410 for Injection in Solid Tumors

Trial Title: SKB410 for Injection in Solid Tumors

NCT ID: NCT05906537

Condition: Advanced Solid Tumors

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SKB410 for injection
Description: SKB410 for injection is administered every 2 weeks (q2w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
Arm group label: Phase Ia (Dose Escalation Phase)+Phase Ib (Dose Expansion Phase)

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.

Detailed description: This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, PK profile, and anti-tumor efficacy of SKB410 for injection in patients with advanced solid tumors.This study consists of two phases, Phase Ia and Phase Ib: Phase Ia is a dose escalation phase, and subjects with advanced solid tumors will be enrolled to receive SKB410 for Injection; Phase Ib is a dose expansion phase, and the expansion dose(s) for specific cancer will be determined based on Phase Ia result.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. At the time of signing the ICF: age ≥ 18 years, male or female. 2. Phase Ia: 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). 3. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1. 4. Expected survival ≥ 3 months. 5. Subjects with adequate organ and bone marrow function confirmed by laboratory results within 3 days prior to the first dose. 6. Subjects of childbearing potential (male or female) must use effective medical contraception during the study until 6 months after the last dose. 7. Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures. Exclusion Criteria: 1. 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). 2. Has received radiotherapy within 4 weeks prior to the first dose. 3. Has had major surgery within 4 weeks prior to the first dose. 4. 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. 5. Has not recovered to normal or ≤ Grade 1 from any AE and/or complication due to any prior therapy (except alopecia or pigmentation). 6. Has known history of allergy to any component of SKB410 or other monoclonal antibodies. 7. Has a known previous or concurrent other malignancies within 5 years prior to signing the ICF. 8. Presence of active central nervous system (CNS) metastases and/or carcinomatous meningitis. 9. Has active autoimmune disease with systemic therapy or immunosuppressive therapy within 2 years prior to signing the ICF. 10. Has uncontrolled or severe cardiovascular disease. 11. Has uncontrolled systemic diseases. 12. Presence of clear neurological or psychiatric disorder. 13. Has active infection requiring systemic. 14. Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis. 15. Pregnant or lactating. 16. Has prior autologous/allogeneic hematopoietic stem cell transplantation or solid organ transplantation. 17. Has any other conditions such as medical history, treatment and laboratory abnormalities that may confound the study results, interfere with the subject's compliance, or impair the subject's interests, as assessed by the investigator or the sponsor.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Status: Recruiting

Contact:
Last name: Lin Shen, Dr.

Investigator:
Last name: Lin Shen, Dr.
Email: Principal Investigator

Start date: June 30, 2023

Completion date: June 30, 2025

Lead sponsor:
Agency: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Agency class: Industry

Source: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05906537