Metastatic Breast CancerPhase 1/2NCT07336771
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
A Phase 1/2 study testing JSKN016 Q2W, JSKN016 Q3W and D-0502 in people with Metastatic Breast Cancer and Locally Advanced Breast Cancer (LABC), run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective estrogen receptor degrader (SERD) D-0502 in patients with locally advanced or metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
- What is being tested?
- JSKN016 Q2W, JSKN016 Q3W and D-0502
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Jun 2028
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Histologically or cytologically confirmed locally advanced or metastatic HR-positive, HER2-negative breast cancer
- HR-positive defined as ER and/or PR ≥1% by IHC
- HER2-negative per ASCO/CAP guidelines
- At least one measurable extracranial lesion per RECIST v1.1
- ECOG performance status 0-1
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- Prior progression on CDK4/6 inhibitor plus endocrine therapy
- Adequate organ and cardiac function
- Postmenopausal women, or premenopausal women receiving ovarian function suppression
Who cannot join
- Active or untreated CNS metastases
- Prior treatment with ADCs containing topoisomerase I inhibitor payloads
- Active interstitial lung disease or pneumonitis
- Uncontrolled cardiovascular disease or active infection
- Prior malignancy within 5 years (with specific exceptions)
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer center
Shanghai
Jian Zhang, +86-21-64175590, syner2000@163.com
About this study
Official title: A Multicenter, Open-Label, Phase Ib/II Randomized Study of JSKN016 in Combination With D-0502 in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective estrogen receptor degrader (SERD) D-0502 in patients with locally advanced or metastatic hormone receptor-positive (HR+), HER2-negative breast cancer who have previously progressed on CDK4/6 inhibitor-based endocrine therapy.
Approximately 60 patients will be randomized in a 1:1 ratio to receive JSKN016 administered intravenously every 2 weeks (Q2W) or every 3 weeks (Q3W), in combination with daily oral D-0502. Each dosing cohort will include a safety lead-in phase to assess DLTs prior to cohort expansion. Tumor response will be assessed according to RECIST v1.1.
- Being tested
- JSKN016 Q2W, JSKN016 Q3W, D-0502
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSKN016 Q2WDrug
4 mg/kg, intravenous infusion, every 2 weeks
JSKN016 Q3WDrug
4 mg/kg, intravenous infusion, every 3 weeks
D-0502Drug
200 mg, oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| JSKN016 Q2W + D-0502 | Experimental | Not described Receives: Drug: JSKN016 Q2W; Drug: D-0502 |
| JSKN016 Q3W + D-0502 | Experimental | Not described Receives: Drug: JSKN016 Q3W; Drug: D-0502 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Measured: From first dose through the end of Cycle 1 (approximately 21 days)
Objective Response Rate (ORR)
Measured: From first dose through treatment discontinuation, assessed up to 12 months
Safety and tolerability (TEAEs, TRAEs, SAEs)
Measured: From first dose until 30 days after the last dose of study treatment.
Secondary outcomes (5)
Disease Control Rate (DCR)
Measured: From first dose through 24 weeks
Duration of Response (DoR)
Measured: From first documented objective response (CR or PR) until disease progression or death, whichever occurs first, assessed up to 24 months
Clinical Benefit Rate (CBR)
Measured: From first dose through 24 weeks
Progression-Free Survival (PFS)
Measured: From first dose until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months
Overall Survival (OS)
Measured: From first dose until death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Alphamab Biopharmaceuticals Co., LtdThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336771
- Sponsor's protocol ID
- JSKN016-204
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase Ib/II Randomized Study of JSKN016 in Combination With D-0502 in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07336771
- Acronym / sponsor ID
- JSKN016-204
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Jan 2026 (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.
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective estrogen receptor degrader (SERD) D-0502 in patients with locally advanced or metastatic hormone receptor-positive (HR+), HER2-negative breast cancer who have previously progressed on CDK4/6 inhibitor-based endocrine therapy.
Approximately 60 patients will be randomized in a 1:1 ratio to receive JSKN016 administered intravenously every 2 weeks (Q2W) or every 3 weeks (Q3W), in combination with daily oral D-0502. Each dosing cohort will include a safety lead-in phase to assess DLTs prior to cohort expansion. Tumor response will be assessed according to RECIST v1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JSKN016 Q2W + D-0502 | Experimental | Drug: JSKN016 Q2W, Drug: D-0502 |
| JSKN016 Q3W + D-0502 | Experimental | Drug: JSKN016 Q3W, Drug: D-0502 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- Histologically or cytologically confirmed locally advanced or metastatic HR-positive, HER2-negative breast cancer
- HR-positive defined as ER and/or PR ≥1% by IHC
- HER2-negative per ASCO/CAP guidelines
- At least one measurable extracranial lesion per RECIST v1.1
Key exclusion criteria (6 listed)
- Active or untreated CNS metastases
- Prior treatment with ADCs containing topoisomerase I inhibitor payloads
- Active interstitial lung disease or pneumonitis
- Uncontrolled cardiovascular disease or active infection
- Prior malignancy within 5 years (with specific exceptions)
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 |
|---|---|---|
| JSKN016 Q2W4 mg/kg, intravenous infusion, every 2 weeks | Drug | JSKN016 Q2W + D-0502 |
| JSKN016 Q3W4 mg/kg, intravenous infusion, every 3 weeks | Drug | JSKN016 Q3W + D-0502 |
| D-0502200 mg, oral, once daily | Drug | JSKN016 Q2W + D-0502, JSKN016 Q3W + D-0502 |
Primary outcome
Incidence of dose-limiting toxicities (DLTs)
Time frame: From first dose through the end of Cycle 1 (approximately 21 days)
Objective Response Rate (ORR)
Time frame: From first dose through treatment discontinuation, assessed up to 12 months
Safety and tolerability (TEAEs, TRAEs, SAEs)
Time frame: From first dose until 30 days after the last dose of study treatment.
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: From first dose through 24 weeks
Duration of Response (DoR)
Time frame: From first documented objective response (CR or PR) until disease progression or death, whichever occurs first, assessed up to 24 months
Clinical Benefit Rate (CBR)
Time frame: From first dose through 24 weeks
Progression-Free Survival (PFS)
Time frame: From first dose until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months
Overall Survival (OS)
Time frame: From first dose until death from any cause, assessed up to 36 months
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 13 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JSKN016 Q2W, JSKN016 Q3W and D-0502 in people with Metastatic Breast Cancer and Locally Advanced Breast Cancer (LABC), run by Jiangsu Alphamab Biopharmaceuticals 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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Jan 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Xiaowen Tang (+86-512-62850800, xiaowentang@alphamabonc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) (time frame: From first dose through the end of Cycle 1 (approximately 21 days)). The study lists 3 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 13 Jan 2026.