COMPANY

HiFiBiO Therapeutics

HQ: Cambridge, MA source · hifibio.com ↗

Keywords: antibody monoclonal antibody Renal Cell Carcinoma Melanoma Non Small Cell Lung Cancer Gastric Cancer Head and Neck Squamous Cell Carcinoma Colorectal Cancer Sarcoma Testicular Germ Cell Tumor Cervical Cancer Mesothelioma Soft Tissue Sarcoma Uterine Carcinosarcoma Hepatocellular Carcinoma HFB30132A HFB200603 HFB200301 HFB301001

Profile checked Oct 10, 2026

5Trials (company is sponsor)

Timeline

May 9, 2023 Trial start Phase 1: A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors source ↗
Apr 20, 2022 Trial start Phase 1: A Study of HFB301001 in Adult Patients With Advanced Solid Tumors source ↗
Mar 10, 2022 Trial start Phase 1: A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors source ↗
May 9, 2021 Trial start Phase 1: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Chinese Healthy Adults source ↗
Oct 20, 2020 Trial start Phase 1: Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults source ↗

Upcoming milestones

2026-12 (ESTIMATED) · Phase 1 · A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors · NCT05789069
2026-12 (ESTIMATED) · Phase 1 · A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors · NCT05238883

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 5

Record	Title	Phase	Status	Start	Primary completion
NCT05789069	A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors	Phase 1	Active, not recruiting	May 9, 2023	2026-12 (estimated)
NCT05238883	A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors	Phase 1	Active, not recruiting	Mar 10, 2022	2026-12 (estimated)
NCT05229601	A Study of HFB301001 in Adult Patients With Advanced Solid Tumors	Phase 1	Terminated	Apr 20, 2022	May 30, 2024 (actual)
NCT05275660	A Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Chinese Healthy Adults	Phase 1	Completed	May 9, 2021	Feb 22, 2022 (actual)
NCT04590430	Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults	Phase 1	Completed	Oct 20, 2020	Jul 26, 2021 (actual)