NCT05229601

A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

Terminated Phase 1 Last updated 22 October 2025

What this trial tests

Phase 1 trial testing HFB301001 in Soft Tissue Sarcoma in 31 participants. Terminated before completion.

Timeline

20 April 2022

Primary endpoint
30 May 2024

30 May 2024

Quick facts

Lead sponsor	HiFiBiO Therapeutics
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	20 April 2022
Primary completion	30 May 2024
Estimated completion	30 May 2024
Sites	10 locations across United States, Spain

Drugs / interventions tested

• HFB301001 — full drug profile →

Conditions studied

• Soft Tissue Sarcoma — all drugs for Soft Tissue Sarcoma →
• Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →
• Uterine Carcinosarcoma — all drugs for Uterine Carcinosarcoma →
• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

HiFiBiO Therapeutics — full company profile →

Who can join

18 and older, any sex, with Soft Tissue Sarcoma or Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable doses of HFB301001 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer they have.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunosuppressive tumor microenvironment in the progression, metastasis, and therapy of hepatocellular carcinoma: from bench to bedside.
   Yin Y, Feng W, Chen J, Chen X, et al · · 2024 · cited 61× · PMID 39085965 · DOI 10.1186/s40164-024-00539-x
2. Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
   Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z
3. OX40/OX40 ligand and its role in precision immune oncology.
   Thapa B, Kato S, Nishizaki D, Miyashita H, et al · · 2024 · cited 45× · PMID 38526805 · DOI 10.1007/s10555-024-10184-9
4. Targeting Co-Stimulatory Receptors of the TNF Superfamily for Cancer Immunotherapy.
   Müller D. · · 2023 · cited 24× · PMID 36571696 · DOI 10.1007/s40259-022-00573-3
5. Delivering co-stimulatory tumor necrosis factor receptor agonism for cancer immunotherapy: past, current and future perspectives.
   Dadas O, Ertay A, Cragg MS. · · 2023 · cited 18× · PMID 37180119 · DOI 10.3389/fimmu.2023.1147467
6. Immune approaches beyond traditional immune checkpoint inhibitors for advanced renal cell carcinoma.
   Jang A, Lichterman JN, Zhong JY, Shoag JE, et al · · 2023 · cited 8× · PMID 37947202 · DOI 10.1080/21645515.2023.2276629
7. Insights in Molecular Therapies for Hepatocellular Carcinoma.
   Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 5× · PMID 38791911 · DOI 10.3390/cancers16101831
8. Unlocking new frontiers: novel immune targets for next-generation cancer immunotherapy.
   Zaheer S, Sureka N. · · 2025 · cited 1× · PMID 40916400 · DOI 10.14216/kjco.24322