Selected Subjects With Advanced Solid TumorsPhase 2NCT05631262
SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors
A Phase 2 study testing SKB264 and Docetaxel in people with Selected Subjects With Advanced Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Selected Subjects With Advanced Solid Tumors
- What is being tested?
- SKB264 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2022to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Expected survival ≥ 12 weeks;
- Adequate organ and bone marrow function;
- 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;
- Subjects who voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol- specified visits and relevant procedures.
Who cannot join
- 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;
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- 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;
- Systemic anti-infective therapy within 2 weeks prior to the first dose;
- Receipt of any systemic anti-tumor therapy such as macromolecular targeted therapy, immunotherapy, etc. within 4 weeks prior to the first dose; receipt of small molecule TKIs, nonspecific immunomodulatory therapy , and Chinese patent drug preparations for approved anti-tumor indications within 2 weeks prior to the first dose;
- Ongoing long-term systemic corticosteroid therapy of > 10 mg prednisone or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory active medication or any form of immunosuppressive therapy prior to the first dose;
- Live vaccines inoculated within 30 days prior to the first dose or planned to be inoculated during the study;
- Rapid deterioration of disease, such as significant changes in performance status during the screening process prior to the first dose;
- Pregnant or lactating women;
- Presence of local or systemic diseases caused by non-malignancies; or diseases or symptoms secondary to tumors that can lead to high medical risks and/or uncertainties in survival evaluation;
- Any condition that, in the opinion of the investigator, make the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
The second part of this study is a randomized, open-label, multicenter Phase 2 clinical study of SKB264 monotherapy versus docetaxel in subjects with locally advanced or metastatic non-squamous NSCLC.
- Being tested
- SKB264, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB264Drug
Subjects of Cohot 1-5 and Part II Test group will receive SKB264 monotherapy
DocetaxelDrug
Part II Control group will receive docetaxel monotherapy.
| Study group | Role | What they receive |
|---|---|---|
| SKB264 (Cohort 1) | Experimental | SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: From baseline until disease progression, death, or other protocol defined reason,up to approximately 21 months.
Duration of response (DOR)
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.
Measured: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.
Disease control rate (DCR)
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.
Measured: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.
Overall survival (OS)
OS is defined as the time period from the start of administration to death due to any cause.
Measured: From baseline until death due to any cause.
Immunogenicity
Presence of Anti-drug antibodys (ADAs) for SKB264.
Measured: From baseline up to 12 months after last patient enrollment.
PK
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB264-ADC, SKB264-TAB and free KL610023.
Measured: From baseline up to 12 months after last patient enrollment.
PK
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB264-ADC, SKB264-TAB and free KL610023.
Measured: From baseline up to 12 months after last patient enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start30 Nov 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Selected Subjects With Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631262
- Sponsor's protocol ID
- SKB264-Ⅱ-08
- Status last verified
- May 2026
- First submitted
- 10 Nov 2022
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40473437Zhao 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.
PubMed 40210967
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05631262
- Acronym / sponsor ID
- SKB264-Ⅱ-08
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The second part of this study is a randomized, open-label, multicenter Phase 2 clinical study of SKB264 monotherapy versus docetaxel in subjects with locally advanced or metastatic non-squamous NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SKB264 (Cohort 1) | Experimental | Drug: SKB264SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle |
| SKB264 (Cohort 2) | Experimental | Drug: SKB264SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle |
| SKB264 (Cohort 3) | Experimental | Drug: SKB264SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle |
| SKB264 (Cohort 4) | Experimental | Drug: SKB264SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle |
| SKB264 (Cohort 5) | Experimental | Drug: SKB264SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle |
| Part II Test group | Experimental | Drug: SKB264SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle |
| Part II Control group | Active comparator | Drug: DocetaxelDocetaxel will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- 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:
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKB264Subjects of Cohot 1-5 and Part II Test group will receive SKB264 monotherapy | Drug | Part II Test group, SKB264 (Cohort 1), SKB264 (Cohort 2), SKB264 (Cohort 3), SKB264 (Cohort 4), SKB264 (Cohort 5) |
| DocetaxelPart II Control group will receive docetaxel monotherapy. | Drug | Part II Control group |
Primary outcome
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.
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.
7 secondary outcomes
Progression-free survival (PFS)
Time frame: From baseline until disease progression, death, or other protocol defined reason,up to approximately 21 months.
Duration of response (DOR)
Time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.
Disease control rate (DCR)
Time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.
Overall survival (OS)
Time frame: From baseline until death due to any cause.
Immunogenicity
Time frame: From baseline up to 12 months after last patient enrollment.
PK
Time frame: From baseline up to 12 months after last patient enrollment.
PK
Time frame: From baseline up to 12 months after last patient enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 40473437Fang 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.
- Derived from this study: PubMed 40210967Zhao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKB264 and Docetaxel in people with Selected Subjects With Advanced Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05631262, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.