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: Active, not 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 is a dose escalation study , and subjects with advanced solid tumors will be enrolled to receive SKB410 for Injection.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer hospital

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. 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 and continue contraception until 210 days after the last dose for female subjects and until 120 days after the last dose for male subjects.
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: Dose Escalation; Several dose levels are planned in the study and administered every 2 weeks.	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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	ORR: it refers to the proportion of subjects with best response of CR or PR after treatment.	through study completion, an average of 2 years
DCR	DCR: it refers to the proportion of subjects with best response of response (PR + CR) and SD after treatment.	through study completion, an average of 2 years
DOR	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.	through study completion, an average of 2 years
PFS	PFS: it refers to the time from the start of treatment until disease progression (PD) or death.	through study completion, an average of 2 years
OS	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-Biotech Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• 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
• product manufactured in and exported from the U.S.: No