A Phase Ⅱ Clinical Study of Combination Therapy of SKB264 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

• Patients with at least one measurable lesion per RECIST v1.1 criteria, and patients with only skin or bone lesions cannot be enrolled;

• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with an expected survival of ≥ 12 weeks;

• Adequate organ and bone marrow function

• For female patients of childbearing age and male patients with partners of childbearing age, they must use effective medical contraception during the study treatment period and for 6 months after the last dose of study medication (see Annex for specific contraceptive measures);

• Each patient must voluntarily agree to participate in the study, sign the informed consent form, and comply with the protocol-specified visits and relevant procedures.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
Contact Information
Primary
XiaoPin Jin
jinxp@kelun.com
028-67255165
Time Frame
Start Date: 2022-05-20
Estimated Completion Date: 2026-04
Participants
Target number of participants: 110
Treatments
Experimental: SKB264+KL-A167
Participants received SKB264 followed by KL-A167
Experimental: SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR wide type)
Participants received SKB264 followed by KL-A167 with Carboplatin or Cisplatin
Experimental: SKB264+KL-A167+ Carboplatin or Cisplatin (EGFR mutation)
Participants received SKB264 followed by KL-A167 with Carboplatin or Cisplatin
Sponsors
Leads: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

This content was sourced from clinicaltrials.gov

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