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Small Cell Lung CancerPhase 2NCT07296809

SKB500 Combinations in Patients With Small Cell Lung Cancer

A Phase 2 study testing SKB500 Powder for Injection, KL-A167 Injection and Carboplatin Injection in people with Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
SKB500 Powder for Injection, KL-A167 Injection and Carboplatin Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
30 Jan 2026to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yan Qing contact

028-67255480

qingyan@kelun.com

China1 site, 1 recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    Yilong Wu, 020 83877855, syylwu@live.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Small Cell Lung Cancer

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.

Being tested
SKB500 Powder for Injection, KL-A167 Injection, Carboplatin Injection, Etoposide Injection
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SKB500 Powder for InjectionDrug

    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.

  • KL-A167 InjectionDrug

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

  • Carboplatin InjectionDrug

    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 InjectionDrug

    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).

Study groups in NCT07296809
Study groupRoleWhat they receive
1. SKB500+KL-A167ExperimentalParticipants will receive KL-A167 followed by SKB500
Receives: Drug: SKB500 Powder for Injection; Drug: KL-A167 Injection
2. SKB500 +KL-A167+CarboplatinExperimentalParticipants will receive KL-A167 followed by SKB500 with Carboplatin
Receives: Drug: SKB500 Powder for Injection; Drug: KL-A167 Injection; Drug: Carboplatin Injection
3. SKB500+KL-A167+Carboplatin+EtoposideExperimentalParticipants will receive KL-A167 followed by SKB500, Carboplatin with Etoposide
Receives: Drug: SKB500 Powder for Injection; Drug: KL-A167 Injection; Drug: Carboplatin Injection; Drug: Etoposide Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 24 months

  2. 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.

    Measured: up to 24 months

Secondary outcomes (7)

  1. 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.

    Measured: up to 24 months

  2. Duration of response (DOR)

    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.

    Measured: up to 24 months

  3. 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.

    Measured: up to 24 months

  4. Overall Survival (OS)

    The time from first dose to death from any cause.

    Measured: up to 24 months

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

    Measured: 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

  6. Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB500-ADC, SKB500-TAB and free payload

    Measured: 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

  7. Anti-drug Antibodies (ADA) for SKB500

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2025
  2. Study start30 Jan 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07296809
Sponsor's protocol ID
SKB500-II-02
Status last verified
May 2026
First submitted
25 Nov 2025
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SKB500 Powder for Injection, KL-A167 Injection and Carboplatin Injection in people with Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yan Qing (028-67255480, qingyan@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AEs) (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07296809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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