Health TrialsbyHealthPanel

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer

ConditionsInoperable Locally Advanced HER2-Negative Breast CancerMetastatic HER2-Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd

About this trial

This study aims to evaluate the safety and effectiveness of JSKN016 in combination with different treatments for patients with HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. The study includes four groups of patients based on treatment history and tumor characteristics. Each group will receive JSKN016 with chemotherapy or immunotherapy. The goal is to find out how well the treatment works and how safe it is.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of understanding and signing the informed consent form.

Aged ≥18 and ≤75 years, regardless of sex.

Histologically or cytologically confirmed inoperable locally advanced or metastatic HER2-negative breast cancer.

Hormone receptor-positive participants with progression/intolerance after standard endocrine therapy, or unsuitable for it.

Disqualifiers

CNS metastasis (except stable cases treated with radiation or surgery).

Unstable spinal cord compression or untreated history.

Recent live vaccine (except seasonal flu vaccines).

Recent anti-tumor treatment within 28 days or 5 half-lives (whichever is shorter).

Trial design

Design model

Single group

Treatments tested in this trial

  • JSKN016

    Drug

    JSKN016 is administered via intravenous infusion at doses of 5mg/kg or 6mg/kg every 3 weeks, starting on Day 1 of each cycle. If the 5mg/kg dose is well tolerated during the safety lead-in phase, the dose may be increased to 6mg/kg for subsequent cycles.

  • Capecitabine

    Drug

    The drug is administered orally at a dose of 1000mg/m², twice daily for two weeks, followed by a one-week break. Treatment cycles repeat every three weeks.

  • Paclitaxel (albumin bound)

    Drug

    The drug is administered intravenously at a dose of 125mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.

  • Eribulin

    Drug

    The drug is administered intravenously at a dose of 1.4mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.

  • Pembrolizumab

    Drug

    The drug is administered intravenously at a fixed dose of 200mg, with infusions on Day 1 of each 3-week treatment cycle.

Treatment groups

180 Participants
are divided into 4 treatment groups
Group A: Cohort 1: JSKN016+PaclitaxelExperimental treatment 2 interventions
Group B: Cohort 2: JSKN016+CapecitabineExperimental treatment 2 interventions
Group C: Cohort 3: JSKN016+EribulinExperimental treatment 2 interventions
Group D: Cohort 4: JSKN016+Pembrolizumab/ToripalimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objetctive Response Rate (ORR)

The proportion of participants who achieve a confirmed complete response (CR) or partial response (PR), as assessed by investigators according to RECIST v1.1 criteria.

Time frame
From baseline until disease progression, death, or end of treatment, whichever occurs first (up to approximately 24 months)

Secondary outcomes

1

Duration of Response (DoR)

The time from the first documentation of CR or PR to the first documentation of disease progression or death from any cause, whichever occurs first, as assessed by investigators per RECIST v1.1.

Time frame
From first documented response to progression or death (up to approximately 24 months)
2

Disease Control Rate (DCR)

The proportion of participants who achieve a best overall response of CR, PR, or stable disease (SD), as assessed by investigators using RECIST v1.1 criteria.

Time frame
From baseline to disease progression or end of treatment (up to approximately 24 months)
3

Progression-Free Survival (PFS)

Time from the date of first dose of study drug to the first documentation of disease progression or death from any cause, whichever occurs first, based on investigator assessment using RECIST v1.1.

Time frame
From first dose until disease progression or death (up to approximately 24 months)
4

Overall Survival (OS)

Time from the date of first dose of study drug to death from any cause.

Time frame
From first dose to death (up to approximately 36 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
Apply now