A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors

NCT06725381 | Recruiting Phase 1

• 1 other identifier: SKB571-I-01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 15

Brief Summary

This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .

Conditions

Solid Malignancies

Outcome Measures

Primary Outcomes (1)

• 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 21 days for treatment

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to 24 months

• Progression Free Survival (PFS)

  Up to 24 months

• Duration of Response (DOR)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

Study Arms (1)

Dose escalation

EXPERIMENTAL

Drug: SKB571

Interventions

SKB571 DRUG

SKB571 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Dose escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18-75 years at the time of signing the informed consent form
• Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors .
• Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
• Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
• Subjects who are assessed by the investigator to have an expected survival of ≥ 3 months.
• Subjects who have adequate organ function.
• Subjects who have recovered from all toxicities due to prior therapy .
• Male and female subjects must agree to use highly effective contraception methods during the study treatment.
• Subjects who voluntarily sign the informed consent form.

You may not qualify if:

• Subjects with known active or untreated central nervous system (CNS) metastases.
• Subjects with other malignant tumors within 3 years prior to the first dose.
• Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
• Subjects with known active pulmonary tuberculosis.
• Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
• Subjects with major surgery within 28 days prior to the first dose.
• Subjects with known allergy or hypersensitivity to SKB571 or its excipients.
• Subjects with clinically severe lung injuries due to pulmonary complications.
• Subjects with a history of allogeneic tissue/solid organ transplant.
• Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.
• Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study.
• Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer.
• Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment.
• Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment.
• Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses \> 10 mg/d or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (15)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

The Affliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

RECRUITING

Guangxi Medical University Cancer Hospital

Linyi, Shandong, China

RECRUITING

Si Chuan Cancer Hospital

Chengdu, Sichuan, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Bei Jing Cancer Hospital

Beijing, China

NOT YET RECRUITING

Chongqing University Cancer Hospital

Chongqing, China

RECRUITING

Shanghai East Hospital

Shanghai, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, China

NOT YET RECRUITING

Zhongshan Hospital

Shanghai, China

RECRUITING

Central Study Contacts

Xin Li

CONTACT

086-010-58302512; lixin@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 10, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CN (15)