SKB500 Combinations in Patients With Small Cell Lung Cancer

NCT07296809 | Recruiting Phase 2

• 1 other identifier: SKB500-II-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events (AEs)

  Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  up to 24 months

• Progression-free survival (PFS)

  Progression-free survival (PFS) was defined as the time from baseline to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

  up to 24 months

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  up to 24 months

• Duration of response (DOR)

  up to 24 months

• Disease control rate (DCR)

  up to 24 months

• Overall Survival (OS)

  up to 24 months

• Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB500-ADC, SKB500-TAB and free payload

  Cycle 1-4, 6, 8,12,16, every 8 cycles starting from Cycle 16 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months

Study Arms (3)

1. SKB500+KL-A167

EXPERIMENTAL

Participants will receive KL-A167 followed by SKB500

Drug: SKB500 Powder for Injection; Drug: KL-A167 Injection

2. SKB500 +KL-A167+Carboplatin

EXPERIMENTAL

Participants will receive KL-A167 followed by SKB500 with Carboplatin

Drug: SKB500 Powder for Injection; Drug: KL-A167 Injection; Drug: Carboplatin Injection

3. SKB500+KL-A167+Carboplatin+Etoposide

EXPERIMENTAL

Participants will receive KL-A167 followed by SKB500, Carboplatin with Etoposide

Drug: SKB500 Powder for Injection; Drug: KL-A167 Injection; Drug: Carboplatin Injection; Drug: Etoposide Injection

Interventions

SKB500 Powder for Injection DRUG

SKB500 will be administered as an intravenous (IV) infusion, every 3 weeks on Day 1 of each 21-day cycle and the dose will be determined based on the efficacy and safety data from the SKB500-I-01 study.

1. SKB500+KL-A167; 2. SKB500 +KL-A167+Carboplatin; 3. SKB500+KL-A167+Carboplatin+Etoposide

KL-A167 Injection DRUG

KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)

1. SKB500+KL-A167; 2. SKB500 +KL-A167+Carboplatin; 3. SKB500+KL-A167+Carboplatin+Etoposide

Carboplatin Injection DRUG

Carboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle（AUC 5, Cycles 1-4)

2. SKB500 +KL-A167+Carboplatin; 3. SKB500+KL-A167+Carboplatin+Etoposide

Etoposide Injection DRUG

Etoposide will be administered as an intravenous (IV) infusion every 3 weeks on Day 1, 2, and 3 of each 21-day cycle (100 mg/m\^2, Cycles 1-4).

3. SKB500+KL-A167+Carboplatin+Etoposide

Eligibility Criteria

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

You may qualify if:

• Male or female participants between 18 and 75 years old.
• Histologically or cytologically confirmed Extensive-stage small cell lung cancer (ES-SCLC):
• Cohort 1: participant has received or not received prior systemic treatment, with no more than 1 prior systemic therapy in the extensive stage.
• Cohort 2\~3: participant has received no prior systemic treatment.
• Agree to provide fresh or archival tumor tissue for biomarker analysis.
• Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy \>= 12 weeks.
• Has adequate organ and bone marrow functions.
• Has recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.
• Effective contraceptive methods should be used during the study and for 6 months after the end of treatment.
• Voluntarily join this study, sign the informed consent form, and can comply with the protocol-specified visits and procedures.

You may not qualify if:

• The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components.
• Has previously received medications with the same target or the same toxins.
• Presence of spinal cord compression or clinically active central nervous system metastases.
• Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels.
• Severe infection within 4 weeks or active infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose.
• With peripheral neuropathy of grade ≥ 2.
• History of any serious, life threatening, or permanently discontinuing adverse events mediated by immunotherapy, including infusion reactions.
• Presence of uncontrolled concurrent diseases, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Severe active peptic ulcer, gastrointestinal bleeding, gastrointestinal perforation, intestinal obstruction, etc.
• Serious or uncontrolled heart disease or clinical symptoms requiring treatment.
• History of interstitial lung disease (ILD) /noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis.
• Clinical severe lung damage caused by concurrent lung disease.
• Uncontrolled hypertension, diabetes, or repeated drainage of pleural effusion/pericardial effusion/ abdominal effusion.
• Pregnant or lactating women.
• Rapid disease deterioration in the screening process.

Sponsors & Collaborators

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

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Injections; 18-O-demethylcervinomycin A2; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Yilong Wu

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Qing

CONTACT

028-67255480; qingyan@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 22, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

CN (1)