SI-B003

Phase 2Small molecule

SI-B003 is one of 301 small molecule programs targeting Head and Neck Squamous Cell Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

300

Competitors

Pipeline

Status by Indication[3][1]

Indication

Head and Neck Squamous Cell CarcinomaActive, not recruiting

Squamous Cell Carcinoma of Head and NeckActive, not recruiting

Patients With Advanced Solid TumorsActive, not recruiting

Breast CancerRecruiting

Colorectal CancerRecruiting

Cervical CancerRecruiting

Small Cell Lung CancerRecruiting

Urothelial CarcinomaRecruiting

Non-Small Cell Lung CancerRecruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Active, not recruiting

Squamous Cell Carcinoma of Head and NeckPreclinical

Active, not recruiting

Patients With Advanced Solid TumorsPhase 1

Active, not recruiting

Breast CancerPhase 2

Recruiting

Colorectal CancerPhase 2

Recruiting

Cervical CancerPhase 2

Recruiting

Small Cell Lung CancerPhase 2

Recruiting

Urothelial CarcinomaPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 2

Recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

SI-B003

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 2

1 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 5

Tricor

JJagotec

Preclinical

1 6

Duragesic

CCephalon

Preclinical

1 7

Rilvegostomig

AstraZeneca

Preclinical

1 8

Ablavar

LLantheus Medical Imaging

Preclinical

2 9

Dextromethorphan Hydrobromide

Boehringer Ingelheim

Preclinical

1 10

Naltrexone/bupropion

Novo Nordisk

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Head and Neck Squamous Cell Carcinoma

NCT06668961

Q4 2027

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT05956587

Phase 2Recruiting

Head and Neck Squamous Cell Carcinoma

NCT06006169

Phase 2Recruiting

Colorectal Cancer

NCT06008054

Phase 2Recruiting

Cervical Cancer

NCT05990803

Phase 2Recruiting

Breast Cancer

NCT06042894

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05956587·121 enrolled

A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of SI-B001+SI-B003 With or Without Chemotherapy (SI-B001+SI-B003± Chemotherapy) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT05949606·95 enrolled

Head and Neck Squamous Cell Carcinoma2 trials

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06006169·186 enrolled

A Phase II Clinical Study to Evaluate the Safety and Efficacy of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy (SI-B001+SI-B003+ Platinum-based Chemotherapy) as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06668961·48 enrolled

Patients With Advanced Solid Tumors1 trial

A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT04606472·60 enrolled

Colorectal Cancer1 trial

A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06008054·376 enrolled

Cervical Cancer1 trial

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05990803·130 enrolled

4 more indications

Breast Cancer1 trial

A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06042894·58 enrolled

Urothelial Carcinoma1 trial

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05965856·52 enrolled

Squamous Cell Carcinoma of Head and Neck1 trial

A Phase Ib/II Clinical Study of SI-B001+SI-B003 Dual-drug No-combination or Combined Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT05668858·70 enrolled

Small Cell Lung Cancer1 trial

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Extensive Stage Small Cell Lung Cancer (SCLC)

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05924841·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for SI-B003. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — SI-B003 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for SI-B003. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sichuan Baili Pharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: SSichuan Baili Pharmaceutical Co., Ltd.

SI-B003

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

Head and Neck Squamous Cell Carcinoma2 trials

Patients With Advanced Solid Tumors1 trial

Colorectal Cancer1 trial

Cervical Cancer1 trial

Breast Cancer1 trial

Urothelial Carcinoma1 trial

Squamous Cell Carcinoma of Head and Neck1 trial

Small Cell Lung Cancer1 trial

References

Drug Info

Quick Facts

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