Active — Not RecruitingPhase 2

SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer

China175 participantsStarted 2022-08-17

Plain-language 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 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 .

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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;
✓. 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;

Exclusion criteria

What they're measuring

Incidence and severity of adverse events (AEs)

Timeframe: 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)

Timeframe: From baseline to first documented objective response, up to 24 months

Trial details

NCT IDNCT05445908

SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Triple-negative Breast Cancer and HR+/HER2- BC trials