SKB410 for Injection in Solid Tumors

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SKB410 for injection

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 Type: Interventional
• Enrollment (Estimated): 276
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shen Lin, MD; Phone Number: 86-010-88196561; Email: doctorshenlin@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR, DCR, DOR, PFS, OS	ORR: it refers to the proportion of subjects with best response of CR or PR after treatment.; DCR: it refers to the proportion of subjects with best response of response (PR + CR) and SD after treatment.; DOR: it refers to the time from the subject's first assessment of CR or PR to disease progression or death due to any cause.; PFS: it refers to the time from the start of treatment until disease progression (PD) or death.; OS: it refers to the time from the first dose to death due to any cause (the last follow-up time for subjects who are lost to follow-up; the end of follow-up date for subjects who are still alive at the end of the study).	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Estimated): June 16, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SKB410-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No