H101

Phase 2Small molecule

FFudan University

H101 is one of 178 small molecule programs targeting Biliary Tract Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

177

Competitors

Pipeline

Status by Indication[3][1]

Indication

Biliary Tract CancerUnknown status

Pancreatic CancerNot yet recruiting

Hepatocellular CarcinomaActive, not recruiting

Head and Neck Squamous Cell CarcinomaRecruiting

Targeted TherapyNot yet recruiting

Oncolytic VirusActive, not recruiting

Biliary Tract CancerPhase 2

Unknown status

Pancreatic CancerPhase 2

Not yet recruiting

Hepatocellular CarcinomaPreclinical

Active, not recruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Recruiting

Targeted TherapyPhase 2

Not yet recruiting

Oncolytic VirusPhase 2

Active, not recruiting

Competition

Competitive Landscape

306 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

H101

FFudan University

Phase 2

2 2

Byetta

AstraZeneca

Preclinical

1 3

Medrol

Pfizer

Preclinical

1 4

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 5

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 7

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 8

Active Comparator

Moderna

Preclinical

1 9

Secretin-Ferring

Ferring

Preclinical

1 10

Sulfonylureas

Eli Lilly

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 2Not yet recruiting

Biliary Tract Cancer

NCT06919848

Q1 2028

Phase 2Not yet recruiting

Pancreatic Cancer

NCT06196671

Q4 2028

Phase 2Recruiting

Head and Neck Squamous Cell Carcinoma

NCT07398664

Q1 2029

Phase 2Not yet recruiting

Targeted Therapy

NCT07381309

Clinical

Trials by Indication[1]

Biliary Tract Cancer2 trials

Oncolytic Virotherapy Combined With Tislelizumab Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer (OPTIONS-05)

Unknown status·FFudan University·Phase 2·NCT05823987·25 enrolled

Oncolytic Virus H101 Combined With Lenvatinib Plus Toripalimab Compared With FOLFOX in Patients With Advanced Biliary Tract Cancer (OPTIONS-06)

Not yet recruiting·FFudan University·Phase 2·NCT06919848·74 enrolled

Pancreatic Cancer2 trials

Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer

Not yet recruiting·FFudan University·Phase 2·NCT06196671·30 enrolled

Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib for Patients With Advanced Pancreatic Cancer

Completed·FFudan University·Phase 1·NCT05303090·56 enrolled

Ascites1 trial

Oncolytic Virotherapy Plus PD-1 Inhibitor for Patients With Refractory Malignant Ascites

Unknown status·FFudan University·Phase 1·NCT05303844·25 enrolled

Hepatocellular Carcinoma1 trial

Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.

Unknown status·SSouthwest Hospital, China·N/A·NCT03790059·160 enrolled

Unresectable1 trial

HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B

Unknown status·SSun Yat-sen University·Phase 3·NCT03780049·304 enrolled

3 more indications

Oncolytic Virus1 trial

Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies

Active, not recruiting·LLiu Zi·Phase 2·NCT05051696·120 enrolled

Targeted Therapy1 trial

Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM

Not yet recruiting·JJun Huang·Phase 2·NCT07381309·114 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Recombinant Human Adenovirus 5 (H101) Combined With Transcatheter Arterial Chemoembolization (TACE) for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Single-Center, Prospective Study

Recruiting·WWest China Hospital·Phase 2·NCT07398664·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for H101. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — H101 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for H101. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Fudan University company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: FFudan University

H101

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q1 2028

Q4 2028

Q1 2029

Trials by Indication[1]

Biliary Tract Cancer2 trials

Pancreatic Cancer2 trials

Ascites1 trial

Hepatocellular Carcinoma1 trial

Unresectable1 trial

Oncolytic Virus1 trial

Targeted Therapy1 trial

Head and Neck Squamous Cell Carcinoma1 trial

References

Drug Info

Quick Facts

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