SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

NCT05631262 | Active Not Recruiting Phase 2

• 1 other identifier: SKB264-Ⅱ-08
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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 5 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.

Conditions

Selected Subjects With Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  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.

  From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.

• 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.

  From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment.

Secondary Outcomes (7)

• Progression-free survival (PFS)

  From baseline until disease progression, death, or other protocol defined reason,up to approximately 21 months.

• Duration of response (DOR)

  From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.

• Disease control rate (DCR)

  From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.

• Overall survival (OS)

  From baseline until death due to any cause.

• Immunogenicity

  From baseline up to 12 months after last patient enrollment.

Study Arms (7)

SKB264 (Cohort 1)

EXPERIMENTAL

SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle

Drug: SKB264

SKB264 (Cohort 2)

EXPERIMENTAL

SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle

Drug: SKB264

SKB264 (Cohort 3)

EXPERIMENTAL

SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle

Drug: SKB264

SKB264 (Cohort 4)

EXPERIMENTAL

SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle

Drug: SKB264

SKB264 (Cohort 5)

EXPERIMENTAL

SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle

Drug: SKB264

Part II Test group

EXPERIMENTAL

SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle

Drug: SKB264

Part II Control group

ACTIVE COMPARATOR

Docetaxel will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle

Drug: Docetaxel

Interventions

SKB264 DRUG

Subjects of Cohot 1-5 and Part II Test group will receive SKB264 monotherapy

Part II Test group; SKB264 (Cohort 1); SKB264 (Cohort 2); SKB264 (Cohort 3); SKB264 (Cohort 4); SKB264 (Cohort 5)

Docetaxel DRUG

Part II Control group will receive docetaxel monotherapy.

Part II Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;
• The following histologically or cytologically confirmed tumor types will be enrolled:
• Part Ⅰ Cohort 1, Cohort 2, Cohort 3, Cohort 5 and Part Ⅱ: histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC);
• Part Ⅰ Cohort 4: histologically or cytologically confirmed nonkeratinizing differentiated or undifferentiated nasopharyngeal carcinoma (NPC) ;
• For subjects enrolled in Part I Cohort 1 and Part II, the following criteria must be met:①EGFR-sensitive mutations confirmed by tumor histology or cytology or hematology;②Failure of prior EGFR-TKI therapy and chemotherapy;
• For subjects enrolled in Part I Cohort 2, the following criteria must be met:①EGFR-sensitive mutations confirmed by tumor histology or cytology or hematology;②Failure of prior EGFR-TKI therapy;③No prior systemic therapy for locally advanced or metastatic NSCLC other than EGFR-TKI therapy;
• For subjects enrolled in Part I Cohort 3, the following criteria must be met:
• ①NSCLC confirmed by tumor histology to be EGFR wild-type and negative for ALK fusion gene; ②Subjects must have met one of the following conditions for prior systemic therapy:A. Have received platinum-based chemotherapy in combination with anti-PD-1/L1 monoclonal antibody therapy as the only prior first-line therapy;B. Have received sequential treatment with platinum-based chemotherapy and anti-PD-1/L1 monoclonal antibody (in either order) as the only prior second-line therapy;
• For subjects enrolled in Part I Cohort 4, the following criteria must be met:
• Have received prior second-line or above systemic therapies and have progressed on or after treatment, with prior therapies including platinum-based chemotherapy and anti-PD-1/PD-L1 monoclonal antibody therapy;
• For subjects enrolled in Part I Cohort 5, the following criteria must be met:
• ①The presence of other driver gene alterations confirmed by tumor histology or cytology or hematology other than EGFR-sensitive mutations ;②have failed targeted therapy for applicable genetic alterations or chemotherapy;
• PD as assessed by imaging on or after the most recent treatment for locally advanced or metastatic disease;
• Ability to provide fresh or archival tumor tissue for biomarker testing and analysis.
• At least one measurable target lesion per RECIST 1.1;

You may not qualify if:

• For NSCLC, histologically or cytologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components;
• Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active brain metastases.
• Other malignancies within 3 years prior to the first dose;
• Presence of any cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors:
• Uncontrolled systemic disease as judged by the investigator:
• 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;
• Clinically serious lung injuries caused by lung diseases, including but not limited to any underlying lung diseases or prior pneumonectomy;
• Presence of active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute GI tract bleed;
• Toxicities treated by prior anti-tumor therapy having not recovered to ≤ Grade 1 (as per NCI CTCAE V5.0) or to the levels specified in the eligibility criteria;
• Presence of active hepatitis B or hepatitis C;
• Subjects with HIV test positive or history of AIDS; known active syphilis infection;
• Known allergy to the study drug or any of its components, and a history of known severe hypersensitivity to other monoclonal antibodies;
• Prior TROP2-targeted therapy;
• Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);
• Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study;

Sponsors & Collaborators

• Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Related Publications (2)

• Fang W, Li X, Wang Q, Meng X, Zheng W, Sun L, Yao W, Zhuang W, Fan Y, Zhuo M, Luo Y, Zhang Z, Song X, Yang R, Yang J, Jin X, Diao Y, Ge J, Zhang L. Sacituzumab tirumotecan versus docetaxel for previously treated EGFR-mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial. BMJ. 2025 Jun 5;389:e085680. doi: 10.1136/bmj-2025-085680.

  PMID: 40473437 DERIVED

• Zhao S, Cheng Y, Wang Q, Li X, Liao J, Rodon J, Meng X, Luo Y, Chen Z, Wang W, Yi T, Li Y, Yin Y, Xu H, Yu G, Mi Y, Fan Y, Wainberg ZA, Wang X, Su C, Yu Q, Lai S, Sun L, Zhuang W, Wang X, Yang J, Li Y, Ge J, Li J, Zhang L, Fang W. Sacituzumab tirumotecan in advanced non-small-cell lung cancer with or without EGFR mutations: phase 1/2 and phase 2 trials. Nat Med. 2025 Jun;31(6):1976-1986. doi: 10.1038/s41591-025-03638-2. Epub 2025 Apr 10.

  PMID: 40210967 DERIVED

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 30, 2022
• Study Start: November 30, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CN (1)