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

Plain English Summary

SKB500 Combinations in Patients With Small Cell Lung Cancer is a Phase 2 clinical trial sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. studying Small Cell Lung Cancer. This trial is testing a new combination of drugs, SKB500 with chemotherapy (Carboplatin and Etoposide) or another drug (KL-A167), for patients with a specific type of lung cancer. It is for adults aged 18-75 with extensive-stage small cell lung cancer who have had limited or no prior treatment. Participation involves receiving the study drugs and attending regular clinic visits for monitoring and tests. Standard chemotherapy or other targeted therapies are current treatment options for this condition. The trial aims to enroll 80 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 to 75 with confirmed extensive-stage small cell lung cancer. Patients who have had no more than one prior treatment for extensive-stage disease, or who have had no prior treatment at all. Individuals with at least one measurable tumor, good general health, and adequate organ function. People who are not pregnant or breastfeeding and can use effective birth control. This trial is studying Small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The trial will measure how long patients live without their cancer getting worse (progression-free survival) and the overall rate of serious side effects, helping to understand if the new treatment is The specific primary outcome measures are: Incidence and severity of adverse events (AEs) (up to 24 months); Progression-free survival (PFS) (up to 24 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for new treatments for small cell lung cancer, a disease with limited effective options, by investigating novel drug combinations. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial explores a new combination therapy for a challenging cancer, potentially offering a new treatment option and indicating investment in novel oncology drug development. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific drugs being tested, potential side effects, and how this trial compares to standard treatments. Be prepared for regular clinic visits for drug infusions, blood tests, scans, and to report any side effects. You will need to provide tumor tissue samples for analysis to help understand how the drugs work. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 80 participants

Interventions

• DRUG: SKB500 Powder for Injection — 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.
• DRUG: KL-A167 Injection — KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)
• DRUG: Carboplatin Injection — 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)
• DRUG: Etoposide Injection — 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).

Primary Outcomes

• Incidence and severity of adverse events (AEs) (up to 24 months)
• Progression-free survival (PFS) (up to 24 months)

Secondary Outcomes

• 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)

Full Eligibility Criteria

Inclusion Criteria:

1. Male or female participants between 18 and 75 years old.
2. 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.
3. Agree to provide fresh or archival tumor tissue for biomarker analysis.
4. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy \>= 12 weeks.
7. Has adequate organ and bone marrow functions.
8. Has recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.
9. Effective contraceptive methods should be used during the study and for 6 months after the end of treatment.
10. Voluntarily join this study, sign the informed consent form, and can comply with the protocol-specified visits and procedures.

Exclusion Criteria:

1. The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components.
2. Has previously received medications with the same target or the same toxins.
3. Presence of spinal cord compression or clinically active central nervous system metastases.
4. Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels.
5. Severe infection within 4 weeks or active infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose.
6. With peripheral neuropathy of grade ≥ 2.
7. History of any serious, life threatening, or permanently discontinuing adverse events mediated by immunotherapy, including infusion reactions.
8. 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.
9. Serious or uncontrolled heart disease or clinical symptoms requiring treatment.
10. History of interstitial lung disease (ILD) /noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis.
11. Clinical severe lung damage caused by concurrent lung disease.
12. Uncontrolled hypertension, diabetes, or repeated drainage of pleural effusion/pericardial effusion/ abdominal effusion.
13. Pregnant or lactating women.
14. Rapid disease deterioration in the screening process.

Trial Locations

• Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Frequently Asked Questions

Related Conditions

• Small Cell Lung Cancer
• Extensive-Stage Small Cell Lung Cancer
• Lung Cancer
• Oncology
• Chemotherapy
• Targeted Therapy
• Cancer Treatment
• Clinical Trials
• Drug Combinations
• Immunotherapy

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