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SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

Sponsor
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05631262
Collaborator
(none)
237
Enrollment
1
Location
5
Arms
35
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Nov 30, 2022
Anticipated Primary Completion Date :
Oct 30, 2024
Anticipated Study Completion Date :
Oct 30, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. Objective Response Rate (ORR) [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) [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) [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) [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) [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) [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 [From baseline up to 12 months after last patient enrollment.]

    Presence of Anti-drug antibodys (ADAs) for SKB264.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 ;

  1. Ability to provide fresh or archival tumor tissue for biomarker testing and analysis.

  2. At least one measurable target lesion per RECIST 1.1; brain lesions will not considered as target lesions;

  3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;

  4. Expected survival ≥ 12 weeks;

  5. Adequate organ and bone marrow function;

  6. 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;

  7. 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

Locations

Site City State Country Postal Code
1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China

Sponsors and Collaborators

  • Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05631262
Other Study ID Numbers:
  • SKB264-Ⅱ-08
First Posted:
Nov 30, 2022
Last Update Posted:
Nov 30, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Nov 30, 2022