Triple-negative Breast Cancer and HR+/HER2- BCPhase 2NCT05445908
SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
A Phase 2 study testing SKB264 and KL-A167 in people with Triple-negative Breast Cancer and HR+/HER2- BC, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to assess the safety and tolerability and preliminary antitumor activity of SKB264 with/without KL-A167 in patients with unresectable locally advanced, recurrent or metastatic TNBC and HR+/HER2- BC .The study is divided into three parts.Part 1（TNBC）: exploratory phase of the efficacy and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Triple-negative Breast Cancer and HR+/HER2- BC
- What is being tested?
- SKB264 and KL-A167
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesChina
- Study dates
- 17 Aug 2022to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 and ≤ 75 years at the time of signing the informed consent form (ICF);
- Histological and/or cytological diagnosis of TNBC or HR+/HER2- BC based on pathology reports on recent biopsy samples or other pathological samples (central laboratory confirmation is not required)；
- Patients have not received prior systemic chemotherapy for locally advanced, recurrent and metastatic disease；
- Ability to 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;
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- Adequate organ and bone marrow function;
- Patients must recover from all toxicities due to prior treatment (recovery to ≤ Grade 1 based on CTCAE v5.0 assessment, or meeting the inclusion criteria in the protocol) with the exception of alopecia and vitiligo;
- Female subjects of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception during the study treatment period and for 6 months after the end of dosing (see Appendix for specific contraceptive measures);
- Patients 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
- History of other malignancies;
- Patients with a history of central nervous system (CNS) metastases or current CNS metastases.
- Imaging (CT or MRI) shows that the tumor has invaded large blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study；
- Received any systemic immune-stimulatory agents within 4 weeks prior to the first dose of study; Received any traditional Chinese medicine for approved anti-tumor indications within 2 weeks prior to the first dose of study;
- Received other clinical investigational drugs within 4 weeks or major surgery within 4 weeks prior to the first dose of the study treatment;
- Patients who required systemic corticosteroids (> 10 mg/day prednisone or equivalent; low-dose corticosteroids are allowed, such as ≤10 mg/day prednisone or equivalent, if the dose is stable for 4 weeks), or other immunosuppressive therapy within 2 weeks prior to the first dose. Steroids are allowed as prophylaxis for hypersensitivity reactions;
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- Patients who occurred arteriovenous thrombosis within 6 months prior to the first dose of study treatment，Such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism, etc.
- Prior treatment with a TROP2-targeted drug or checkpoint inhibitor ;
- Serious or uncontrolled cardiac disease or clinical symptoms requiring treatment；
- Patients with (noninfectious) interstitial lung disease (ILD) or history of pneumonia requiring steroid therapy; patients with serious pulmonary function impairment due to lung disease;
- Uncontrolled systemic disease as judged by the investigator, included uncontrolled hypertension, uncontrolled diabetes, pesence of pleural effusion, pericardial effusion, or ascites that is clinically symptomatic or requires repeated drainage;
- Active autoimmune disease requiring systemic treatment within the past 2 years;
- Active hepatitis B or hepatitis C; known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); positive syphilis antibody test;
- Known hypersensitivity to the study drug or any of its components, or severe allergic reactions to other monoclonal antibodies;
- Pregnant or lactating women;
- Any patient whose condition deteriorates rapidly during the screening process prior to the first dose, such as severe changes in performance status, unstable pain requiring adjustment of analgesic therapy, etc;
- Other circumstances that, in the opinion of the investigator, are not appropriate for participation in this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hunan Cancer Hospital
Changsha, Hunan, 410031
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
About this study
Official title: A Phase 2 Clinical Study of SKB264 With/Without KL-A167 in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-negative Breast Cancer Who Have Not Received Prior Systemic Therapy
The purpose of this study is to assess the safety and tolerability and preliminary antitumor activity of SKB264 with/without KL-A167 in patients with unresectable locally advanced, recurrent or metastatic TNBC and HR+/HER2- BC .The study is divided into three parts.Part 1（TNBC）: exploratory phase of the efficacy and safety of the combination treatment. Part 2（TNBC）: The subjects will be randomized to treatment group for SKB264 + KL-A167 or SKB264 . Part 3（HR+/HER2- BC）: The subjects will be randomized to treatment group for SKB264 + KL-A167 or SKB264 .
- Being tested
- SKB264, KL-A167
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB264Drug
SKB264 will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle
KL-A167Drug
KL-A167 will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle
| Study group | Role | What they receive |
|---|---|---|
| SKB264+KL-A167（Part1，TNBC） | Experimental | Participants received SKB264 followed by KL-A167 Receives: Drug: SKB264; Drug: KL-A167 |
| SKB264（Part2，TNBC） | Experimental | Participants received SKB264 Receives: Drug: SKB264 |
| SKB264+KL-A167（Part2，TNBC） | Experimental | Participants received SKB264 followed by KL-A167 Receives: Drug: SKB264; Drug: KL-A167 |
| SKB264（Part3，HR+/HER2- BC） | Experimental | Participants received SKB264 Receives: Drug: SKB264 |
| SKB264+KL-A167（Part3，HR+/HER2- BC） | Experimental | Participants received SKB264 followed by KL-A167 Receives: Drug: SKB264; Drug: KL-A167 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 baseline up to 30 days after last dose or to the beginning of the new anti-cancer therapy, up to 24 months
Objective Response Rate (ORR)
Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1.
Measured: From baseline to first documented objective response, up to 24 months
Secondary outcomes (8)
Progression-free survival (PFS)
Progression-free survival (PFS) was defined as the time from baseline to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
Measured: From baseline to the first documented disease progression or date of death (whichever occurs first), up to 24 months
Duration of response (DOR)
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.
Measured: From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 24 months
Disease control rate (DCR)
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Measured: From baseline to date of first documented objective response (CR, PR, and SD), up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB264-ADC, SKB264-TAB and free KL610023
Measured: Cycles 1-3, 5, 7, 9, and 11, every 6 cycles starting from Cycle 17 Day 1: pre-dose, post-dose (each cycle is 14 days), up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB264-ADC, SKB264-TAB and free KL610023
Measured: Cycles 1-3, 5, 7, 9, and 11, every 6 cycles starting from Cycle 17 Day 1: pre-dose, post-dose (each cycle is 14 days), up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of KL-A167
Measured: Cycles 1-3, 5, 7, 9, and 11, every 6 cycles starting from Cycle 17 Day 1: pre-dose, post-dose (each cycle is 14 days), up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of KL-A167
Measured: Cycles 1-3, 5, 7, 9, and 11, every 6 cycles starting from Cycle 17 Day 1: pre-dose, post-dose (each cycle is 14 days), up to 24 months
Anti-drug Antibodies (ADA) for SKB264 and KL-A167
Measured: Cycles 1-3, 5, 7, 9, and 11, every 6 cycles starting from Cycle 17 Day 1: within 1 h before infusion of SKB264 (each cycle is 14 days), up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start17 Aug 2022
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative Breast Cancer and HR+/HER2- BCStudies 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
- 184 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445908
- Sponsor's protocol ID
- SKB264-Ⅱ-07
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2022
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study of SKB264 With/Without KL-A167 in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-negative Breast Cancer Who Have Not Received Prior Systemic Therapy
- ClinicalTrials.gov ID
- NCT05445908
- Acronym / sponsor ID
- SKB264-Ⅱ-07
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 6 Jul 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 tolerability and preliminary antitumor activity of SKB264 with/without KL-A167 in patients with unresectable locally advanced, recurrent or metastatic TNBC and HR+/HER2- BC .The study is divided into three parts.Part 1（TNBC）: exploratory phase of the efficacy and safety of the combination treatment. Part 2（TNBC）: The subjects will be randomized to treatment group for SKB264 + KL-A167 or SKB264 . Part 3（HR+/HER2- BC）: The subjects will be randomized to treatment group for SKB264 + KL-A167 or SKB264 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SKB264+KL-A167（Part1，TNBC） | Experimental | Drug: SKB264, Drug: KL-A167Participants received SKB264 followed by KL-A167 |
| SKB264（Part2，TNBC） | Experimental | Drug: SKB264Participants received SKB264 |
| SKB264+KL-A167（Part2，TNBC） | Experimental | Drug: SKB264, Drug: KL-A167Participants received SKB264 followed by KL-A167 |
| SKB264（Part3，HR+/HER2- BC） | Experimental | Drug: SKB264Participants received SKB264 |
| SKB264+KL-A167（Part3，HR+/HER2- BC） | Experimental | Drug: SKB264, Drug: KL-A167Participants received SKB264 followed by KL-A167 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females aged ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF);
- Histological and/or cytological diagnosis of TNBC or HR+/HER2- BC based on pathology reports on recent biopsy samples or other pathological samples (central laboratory confirmation is not required)；
- Patients have not received prior systemic chemotherapy for locally advanced, recurrent and metastatic disease；
- Ability to 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;
Key exclusion criteria (17 listed)
- History of other malignancies;
- Patients with a history of central nervous system (CNS) metastases or current CNS metastases.
- Imaging (CT or MRI) shows that the tumor has invaded large blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study；
- Received any systemic immune-stimulatory agents within 4 weeks prior to the first dose of study; Received any traditional Chinese medicine for approved anti-tumor indications within 2 weeks prior to the first dose of study;
- Received other clinical investigational drugs within 4 weeks or major surgery within 4 weeks prior to the first dose of the study treatment;
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 |
|---|---|---|
| SKB264SKB264 will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle | Drug | SKB264+KL-A167（Part1，TNBC）, SKB264+KL-A167（Part2，TNBC）, SKB264+KL-A167（Part3，HR+/HER2- BC）, SKB264（Part2，TNBC）, SKB264（Part3，HR+/HER2- BC） |
| KL-A167KL-A167 will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle | Drug | SKB264+KL-A167（Part1，TNBC）, SKB264+KL-A167（Part2，TNBC）, SKB264+KL-A167（Part3，HR+/HER2- BC） |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: From baseline up to 30 days after last dose or to the beginning of the new anti-cancer therapy, up to 24 months
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Objective Response Rate (ORR)
Time frame: From baseline to first documented objective response, up to 24 months
Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1.
8 secondary outcomes
Progression-free survival (PFS)
Time frame: From baseline to the first documented disease progression or date of death (whichever occurs first), up to 24 months
Duration of response (DOR)
Time frame: From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 24 months
Disease control rate (DCR)
Time frame: From baseline to date of first documented objective response (CR, PR, and SD), up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB264-ADC, SKB264-TAB and free KL610023
Time frame: Cycles 1-3, 5, 7, 9, and 11, every 6 cycles starting from Cycle 17 Day 1: pre-dose, post-dose (each cycle is 14 days), up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB264-ADC, SKB264-TAB and free KL610023
Time frame: Cycles 1-3, 5, 7, 9, and 11, every 6 cycles starting from Cycle 17 Day 1: pre-dose, post-dose (each cycle is 14 days), up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of KL-A167
Time frame: Cycles 1-3, 5, 7, 9, and 11, every 6 cycles starting from Cycle 17 Day 1: pre-dose, post-dose (each cycle is 14 days), up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of KL-A167
Time frame: Cycles 1-3, 5, 7, 9, and 11, every 6 cycles starting from Cycle 17 Day 1: pre-dose, post-dose (each cycle is 14 days), up to 24 months
Anti-drug Antibodies (ADA) for SKB264 and KL-A167
Time frame: Cycles 1-3, 5, 7, 9, and 11, every 6 cycles starting from Cycle 17 Day 1: within 1 h before infusion of SKB264 (each cycle is 14 days), up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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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.
2 sites 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 KL-A167 in people with Triple-negative Breast Cancer and HR+/HER2- BC, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of adverse events (AEs) (time frame: From baseline up to 30 days after last dose or to the beginning of the new anti-cancer therapy, up to 24 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?
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 28 Aug 2026.