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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. SKB500+KL-A167 | Experimental | Participants will receive KL-A167 followed by SKB500 |
|
| 2. SKB500 +KL-A167+Carboplatin | Experimental | Participants will receive KL-A167 followed by SKB500 with Carboplatin |
|
| 3. SKB500+KL-A167+Carboplatin+Etoposide | Experimental | Participants will receive KL-A167 followed by SKB500, Carboplatin with Etoposide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1. | up to 24 months |
| Duration of response (DOR) |
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Inclusion Criteria:
Male or female participants between 18 and 75 years old.
Histologically or cytologically confirmed Extensive-stage small cell lung cancer (ES-SCLC):
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Qing | Contact | 028-67255480 | qingyan@kelun.com |
| Name | Affiliation | Role |
|---|---|---|
| Yilong Wu | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C087128 | 18-O-demethylcervinomycin A2 |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
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| 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) |
|
| 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) |
|
| 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). |
|
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only. |
| up to 24 months |
| Disease control rate (DCR) | Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. | up to 24 months |
| Overall Survival (OS) | The time from first dose to death from any cause. | 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 |
| Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) 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, up to 24 months |
| Anti-drug Antibodies (ADA) for SKB500 | Cycle 1-4, 6, 8, 12, 16, every 8 cycles starting from Cycle 16 Day 1: pre-dose, (each cycle is 21 days), up to 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009930 |
| Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |