SKB410 for Injection in Solid Tumors

Phase 1

Active, not recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SKB410 for injection

• Registration Number: NCT05906537
• Lead Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

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.

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.

Study Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-18
• Study Start: 2023-06-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 276

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase Ia (Dose Escalation Phase)+Phase Ib (Dose Expansion Phase)	SKB410 for injection	Several dose levels are planned for Phase1a and administered every 2 weeks.The dose of SKB410 for injection in Phase 1b is selected based on the Phase 1a.

Primary Outcome Measures

Name	Time	Method
Phase Ib:ORR	through study completion, an average of 2 years	ORR based on RECIST v1.1.
Phase Ia :Number of subjects achieving Dose-limiting toxicity (DLT)	From data of initial dose until up to 28 days for treatment	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.
Phase Ia :Maximum Tolerated Dose (MTD)	From data of initial dose until up to 28 days for treatment	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.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China