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JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer

ConditionsMetastatic Breast CancerLocally Advanced Breast Cancer (LABC)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • JSKN016 Q2W

    Drug

    4 mg/kg, intravenous infusion, every 2 weeks

  • JSKN016 Q3W

    Drug

    4 mg/kg, intravenous infusion, every 3 weeks

  • D-0502

    Drug

    200 mg, oral, once daily

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: JSKN016 Q2W + D-0502Experimental treatment 2 interventions
Group B: JSKN016 Q3W + D-0502Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs)

Time frame
From first dose through the end of Cycle 1 (approximately 21 days)
2

Objective Response Rate (ORR)

Time frame
From first dose through treatment discontinuation, assessed up to 12 months
3

Safety and tolerability (TEAEs, TRAEs, SAEs)

Time frame
From first dose until 30 days after the last dose of study treatment.

Secondary outcomes

1

Disease Control Rate (DCR)

Time frame
From first dose through 24 weeks
2

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
3

Clinical Benefit Rate (CBR)

Time frame
From first dose through 24 weeks
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: