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SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form;

Histologically and cytologically confirmed NSCLC;

Cohort 1: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no or at most one prior line of systemic chemotherapy regimen for advanced or metastatic NSCLC. Cohort 2: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no prior systemic therapy. Cohort 3: Patients with locally advanced/metastatic NSCLC with EGFR activating mutation and negative ALK fusion gene, who have failed previous treatment with EGFR-TKIs.

Provide fresh or archival tumor tissue for biomarker testing and analysis;

Disqualifiers

Presence of small cell lung carcinoma (SCLC) components in histological pathology;

History of other malignancies;

Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression;

Presence of active central nervous system (CNS) metastases;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SKB264

    Drug

    SKB264 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (5mg/kg)

  • KL-A167

    Drug

    KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg Q3W)

  • Carboplatin

    Drug

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

  • Cisplatin

    Drug

    Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (75mg/m²)

Treatment groups

110 Participants
are divided into 3 treatment groups
Group A: SKB264+KL-A167Experimental treatment 2 interventions
Group B: SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR wide type)Experimental treatment 4 interventions
Group C: SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR mutation)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

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

Time frame
From baseline up to 30 days after last dose or to the beginning of the new anti-cancer therapy, up to 24 months
2

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.

Time frame
From baseline to first documented objective response, up to 24 months

Secondary outcomes

1

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. PD was defined as at least a 20% increase in the sum of diameters of target lesions.

Time frame
From baseline to the first documented disease progression or date of death (whichever occurs first), 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.

Time frame
From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), 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 target 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 (PD; at least a 20% increase in the sum of diameters of target lesions.

Time frame
From baseline to date of first documented objective response (CR, PR, and SD), up to 24 months
4

Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB264-ADC, SKB264-TAB and free KL610023

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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