SKB410 for Injection in Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB410 for Injection in Subjects With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: SKB410 for injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At the time of signing the ICF: age ≥ 18 years, male or female. 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). 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 until 6 months after the last dose. Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures. Exclusion Criteria: 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. Has prior autologous/allogeneic hematopoietic stem cell transplantation or solid organ transplantation. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase Ia (Dose Escalation Phase)+Phase Ib (Dose Expansion Phase)<br>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. | Drug: SKB410 for injection<br>* SKB410 for injection is administered every 2 weeks (q2w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase Ia :To assess the safety and tolerability of SKB410 in subjects with advanced solid tumors. | Incidence of Dose Limiting Toxicities,the MTD of SKB410 | From data of initial dose until up to 28 days for treatment | 
| Phase Ib:ORR | ORR based on RECIST v1.1. | through study completion, an average of 2 years |