PD-1 monoclonal antibody

Phase 3Small molecule

PD-1 monoclonal antibody is one of 314 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

313

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaActive, not recruiting

Nasopharyngeal CarcinomaActive, not recruiting

LymphomaActive, not recruiting

Gastric AdenocarcinomaActive, not recruiting

Triple-Negative Breast CancerActive, not recruiting

Rectal AdenocarcinomaRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Colorectal CancerRecruiting

Hepatocellular CarcinomaActive, not recruiting

Gastric CancerActive, not recruiting

Gastroesophageal Junction AdenocarcinomaPhase 2

Active, not recruiting

Nasopharyngeal CarcinomaPhase 2

Active, not recruiting

LymphomaPreclinical

Active, not recruiting

Gastric AdenocarcinomaPhase 2

Active, not recruiting

Triple-Negative Breast CancerPhase 2

Active, not recruiting

Rectal AdenocarcinomaPhase 3

Recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Colorectal CancerPhase 3

Recruiting

Hepatocellular CarcinomaPhase 1

Active, not recruiting

Gastric CancerPhase 2

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

PD-1 monoclonal antibody

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

1 2

Oncaspar

SServier

Preclinical

15 3

Velban

EEastern Cooperative Oncology Group

Preclinical

15 4

Norvir

AbbVie

Preclinical

1 5

Tafasitamab

Incyte

Preclinical

7 6

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 8

Nuvigil

NNuvo Research GmbH

Preclinical

1 9

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 10

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—

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

Timeline

Expected Milestones

Q3 2026

Phase 1Not yet recruiting

Hepatocellular Carcinoma

NCT06364800

Phase 1Not yet recruiting

Hepatocellular Carcinoma

NCT06364787

Q4 2026

Phase 2Recruiting

Gastroesophageal Junction Adenocarcinoma

NCT06423885

Q1 2027

Phase 3Recruiting

Colorectal Cancer

NCT06794086

Q2 2027

Phase 2Recruiting

Rectal Adenocarcinoma

NCT06908031

Clinical

Trials by Indication[1]

Hepatocellular Carcinoma3 trials

Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial of Hepatocellular Carcinoma Resistant to PD-1 Monoclonal Antibody

Not yet recruiting·—·Phase 1·NCT06364800·18 enrolled

Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

Recruiting·CChen Xiaoping·Phase 4·NCT06311929·300 enrolled

Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma

Not yet recruiting·—·Phase 1·NCT06364787·18 enrolled

Colorectal Cancer2 trials

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

SBRT Combined With PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (SPARKLE-L)

Recruiting·JJun Huang·Phase 3·NCT06794086·24 enrolled

Rectal Adenocarcinoma2 trials

Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS/BRAF Wild-Type)/Bevacizumab (for RAS/BRAF Mutant) in High-Risk pMMR/MSS Rectal Adenocarcinoma: a Prospective, Multicenter Phase II Study(CRIT)

Recruiting·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 2·NCT06908031·49 enrolled

Recruiting·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 3·NCT07549399·204 enrolled

Small Cell Lung Cancer1 trial

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06437509·66 enrolled

Ablation1 trial

Ablation Combined With PD-1 in HCC: Phase II Study

Unknown status·SSun Yat-sen University·Phase 1/2·NCT04652440·30 enrolled

13 more indications

Solid Tumors1 trial

Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.

Completed·PPeking University·Phase 1·NCT03874897·134 enrolled

Lymphoma1 trial

Chemotherapy Plus PD-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T-cell Lymphoma.

Unknown status·OOu Bai, MD/PHD·N/A·NCT05821192·34 enrolled

Gastric Adenocarcinoma1 trial

PD-1 Monoclonal Antibody Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma

Unknown status·HHenan Cancer Hospital·Phase 2·NCT04341857·25 enrolled

First Line Therapy1 trial

Programmed Cell Death Protein-1 (PD-1) Monoclonal Antibody for EBV-HLH and CAEBV as First-line Therapy

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 4·NCT05039580·36 enrolled

Patients With Advanced Solid Tumors1 trial

Safety, Tolerability, and Pharmacokinetics of MW11 in Patients With Advanced Solid Tumors

Unknown status·MMabwell (Shanghai) Bioscience Co., Ltd.·Phase 1·NCT04478461·21 enrolled

Nasopharyngeal Carcinoma1 trial

A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma

Recruiting·SSun Yat-sen University·Phase 2·NCT07392320·142 enrolled

Chemoradiotherapy1 trial

Neoadjuvant Long-course Chemoradiotherapy Followed by Immunotherapy for Locally Advanced Mid-low Rectal Cancer

Completed·PPeking University People's Hospital·Phase 2·NCT06493240·30 enrolled

Non-Small Cell Lung Cancer1 trial

A Study of BL-B01D1+PD-1 Monoclonal Antibody 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·NCT06475300·570 enrolled

Monoclonal1 trial

PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma

Unknown status·GGuangzhou University of Traditional Chinese Medicine·N/A·NCT04430166·12 enrolled

Triple-Negative Breast Cancer1 trial

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06471205·52 enrolled

Gastric Cancer1 trial

Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer

Recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT06468280·84 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06423885·40 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06437522·46 enrolled

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for PD-1 monoclonal antibody. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — PD-1 monoclonal antibody compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for PD-1 monoclonal antibody. 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 3[1]
Company: SSichuan Baili Pharmaceutical Co., Ltd.

PD-1 monoclonal antibody

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Hepatocellular Carcinoma3 trials

Colorectal Cancer2 trials

Rectal Adenocarcinoma2 trials

Small Cell Lung Cancer1 trial

Ablation1 trial

Solid Tumors1 trial

Lymphoma1 trial

Gastric Adenocarcinoma1 trial

First Line Therapy1 trial

Patients With Advanced Solid Tumors1 trial

Nasopharyngeal Carcinoma1 trial

Chemoradiotherapy1 trial

Non-Small Cell Lung Cancer1 trial

Monoclonal1 trial

Triple-Negative Breast Cancer1 trial

Gastric Cancer1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Head and Neck Squamous Cell Carcinoma1 trial

References

Drug Info

Quick Facts

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