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SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05631262
Recruitment Status : Not yet recruiting
First Posted : November 30, 2022
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to assess the safety and efficacy of SKB264 monotherapy in subjects with selected advanced solid tumors.The study is divided into two parts: the Part Ⅰ consists of 4 cohorts, and the Part Ⅱ for expansion. Eligible subjects will receive SKB264 monotherapy, until there is no longer clinical benefit, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Condition or disease Intervention/treatment Phase
Selected Subjects With Advanced Solid Tumors Drug: SKB264 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 237 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors
Estimated Study Start Date : November 30, 2022
Estimated Primary Completion Date : October 30, 2024
Estimated Study Completion Date : October 30, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: SKB264 (Cohort 1)
SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle
 Drug: SKB264
Subjects will receive SKB264 monotherapy.
Experimental: SKB264 (Cohort 2)
SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle
 Drug: SKB264
Subjects will receive SKB264 monotherapy.
Experimental: SKB264 (Cohort 3)
SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle
 Drug: SKB264
Subjects will receive SKB264 monotherapy.
Experimental: SKB264 (Cohort 4)
SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle
 Drug: SKB264
Subjects will receive SKB264 monotherapy.
Experimental: SKB264 (Part 2)
SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle
 Drug: SKB264
Subjects will receive SKB264 monotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months. ]
    ORR is defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR) as the best overall response assessed per RECIST 1.1.

  2. Incidence and severity of adverse events (AEs) [ Time Frame: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment. ]
    Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: From baseline until disease progression, death, or other protocol defined reason,up to approximately 21 months. ]
    PFS is defined as the time from the first dose to progressive disease (PD) or death, whichever occurs first. PD will be assessed per RECIST 1.1.

  2. Duration of response (DOR) [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months. ]
    DOR is defined as the time from the date of first documented CR or PR to PD or death due to any cause, whichever occurs first.

  3. Disease control rate (DCR) [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months. ]
    DCR is defined as the proportion of subjects with CR, PR or stable disease (SD) as the best overall response assessed per RECIST 1.1.

  4. Overall survival (OS) [ Time Frame: From baseline until death due to any cause. ]
    OS is defined as the time period from the start of administration to death due to any cause.

  5. Immunogenicity [ Time Frame: From baseline up to 12 months after last patient enrollment. ]
    Presence of Anti-drug antibodys (ADAs) for SKB264.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;

  2. The following histologically or cytologically confirmed tumor types will be enrolled:

    • Part Ⅰ Cohort 1, Cohort 2, Cohort 3, and Part Ⅱ: histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC), locally advanced (stage ⅢB/ⅢC) or metastatic (stage Ⅳ) NSCLC not amenable to radical surgery and/or radical radiotherapy (regardless of concurrent/sequential chemotherapy) ;
    • Part Ⅰ Cohort 4: histologically or cytologically confirmed nonkeratinizing differentiated or undifferentiated nasopharyngeal carcinoma (NPC) with metastatic (stage ⅣB) NPC not amenable to radical local therapy ;
  3. Ability to provide fresh or archival tumor tissue for biomarker testing and analysis.
  4. At least one measurable target lesion per RECIST 1.1; brain lesions will not considered as target lesions;
  5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  6. Expected survival ≥ 12 weeks;
  7. Adequate organ and bone marrow function;
  8. Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception during the study treatment period and for 6 months after the end of dosing;
  9. Subjects who voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol- specified visits and relevant procedures.

Exclusion Criteria:

  1. For NSCLC, histologically or cytologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components;
  2. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active brain metastases.
  3. Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study;
  4. History of (noninfectious) interstitial pneumonia (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or suspected ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging;
  5. Subjects with HIV test positive or history of AIDS; known active syphilis infection;
  6. Pregnant or lactating women;
  7. Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 2 weeks prior to the first dose;
  8. Requiring strong inhibitors or inducers of CYP3A4 within 2 weeks prior to first dose and during the study (strong inhibitors or inducers of CYP3A4 are not allowed in this study);
  9. Live vaccines inoculated within 30 days prior to the first dose or planned to be inoculated during the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05631262


Contacts
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Contact: XiaoPing Jin +86-028-67255165 jinxp@kelun.com

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Contact: Li Zhang    +86-020-87343458    zhangli@sysucc.org.cn   
Sponsors and Collaborators
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
More Information
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Responsible Party: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
ClinicalTrials.gov Identifier: NCT05631262    
Other Study ID Numbers: SKB264-Ⅱ-08
First Posted: November 30, 2022    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms