SKB264

Phase 3Small molecule

SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

SKB264 is one of 117 small molecule programs targeting Triple-Negative Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

116

Competitors

Pipeline

Status by Indication[3][1]

Indication

Triple-Negative Breast CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerActive, not recruiting

NSCLCRecruiting

Triple-Negative Breast CancerPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

NSCLCPhase 2

Recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

SKB264

SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Phase 3

4 2

Tecentriq

Roche

Preclinical

36 3

Trodelvy

Gilead

Preclinical

37 4

Halaven

Eisai

Preclinical

38 5

Tykerb

GSK

Preclinical

80 6

Adriamycin

GGynecologic Oncology Group

Preclinical

87 7

Avastin

BBio-Thera Solutions

Preclinical

153 8

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 9

Prolia

Amgen

Preclinical

14 10

Gemzar

GGynecologic Oncology Group

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1/2Active, not recruiting

Refractory to Standard Therapies

NCT04152499

Phase 3Active, not recruiting

Phase II

NCT05870319

Q4 2026

Phase 3Active, not recruiting

Non-Small Cell Lung Cancer

NCT06448312

Phase 2Active, not recruiting

Selected Subjects With Advanced Solid Tumors

NCT05631262

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT05816252

Q2 2027

Phase 3Active, not recruiting

Triple-Negative Breast Cancer

NCT05347134

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)

Active, not recruiting·KKlus Pharma Inc.·Phase 2·NCT05816252·356 enrolled

A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Active, not recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT06448312·406 enrolled

SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

Recruiting·SSichuan Kelun Pharmaceutical Research Institute Co., Ltd.·Phase 2·NCT05351788·110 enrolled

Show 2 more trials

A Randomized, Open-Label, Multicenter, Phase III Clinical Study of SKB264 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Active, not recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT06670196·420 enrolled

A Randomized, Open-Label, Multicenter Phase 3 Clinical Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Active, not recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT06711900·432 enrolled

Breast Cancer4 trials

Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases

Not yet recruiting·FFudan University·Phase 2·NCT07466927·30 enrolled

Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer

Recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT06081959·376 enrolled

A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy

Recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT07071337·430 enrolled

Show 1 more trial

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

Active, not recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT05445908·175 enrolled

Triple-Negative Breast Cancer4 trials

A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT06279364·524 enrolled

SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

Active, not recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT05347134·254 enrolled

Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer

Recruiting·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT07371208·40 enrolled

Show 1 more trial

HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer

Not yet recruiting·FFudan University·Phase 2·NCT06849492·120 enrolled

NSCLC2 trials

A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Not yet recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT07697586·206 enrolled

A Multicenter, Single-Arm, Phase II (Simon Two-Stage) Study of Sacituzumab Tirumotecan (SKB264) Plus Glecirasib (KRAS G12C Inhibitor) as First-Line Treatment for KRAS G12C-Mutated Advanced NSCLC

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT07670013·43 enrolled

Selected Subjects With Advanced Solid Tumors1 trial

SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

Active, not recruiting·SSichuan Kelun Pharmaceutical Research Institute Co., Ltd.·Phase 2·NCT05631262·321 enrolled

4 more indications

Phase II1 trial

A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

Active, not recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT05870319·376 enrolled

Efficacy1 trial

Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC

Not yet recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT07341100·20 enrolled

Refractory to Standard Therapies1 trial

Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)

Active, not recruiting·KKlus Pharma Inc.·Phase 1/2·NCT04152499·1,410 enrolled

Pembrolizumab1 trial

SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

Active, not recruiting·KKlus Pharma Inc.·Phase 2·NCT05642780·240 enrolled

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for SKB264. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — SKB264 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for SKB264. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

SKB264

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

Breast Cancer4 trials

Triple-Negative Breast Cancer4 trials

NSCLC2 trials

Selected Subjects With Advanced Solid Tumors1 trial

Phase II1 trial

Efficacy1 trial

Refractory to Standard Therapies1 trial

Pembrolizumab1 trial

References

Drug Info

Quick Facts

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