Neoplasms

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Carcinoma, Hepatocellular

Melanoma

Carcinoma, Renal Cell

Sarcoma

Carcinosarcoma

Mixed Tumor, Mullerian

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Head and Neck Neoplasms

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Soft Tissue Sarcoma

Malignant Mixed Mullerian Tumor

Uterine Carcinosarcoma

All Drugs and Chemicals

Antibodies

Immunoglobulins

Participants will receive HFB301001 via intravenous infusions

Dose Escalation: Participants will be administered dose level 1 in Cohort 1. Participants in Cohorts 2-4 will receive dose levels 2-4, respectively.

Dose Expansion: Participants with certain cancer types will be administered the dose determined at dose escalation.

HFB301001

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.

This is a Phase I, first-in-human, open-label, dose escalation and expansion study in adult patients with advanced cancers. The study will comprise of:

1. A Screening Period of up to 28 days
2. A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 28 days. Number of cycles depends on how the disease responds to the study drug
3. A Follow-Up Period which involves 1 visit

A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients With Advanced Solid Tumors

Percent change in immunologic changes to immune cells in the blood and tumor

HiFiBiO Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of HFB301001 in Adult Patients With Advanced Solid Tumors	NCT05229601	Soft Tissue Sar... Renal Cell Carc... Uterine Carcino... Hepatocellular ... Head and Neck S... Melanoma	HFB301001	18 Years -	HiFiBiO Therapeutics
A Study of HFB301001 in Adult Patients With Advanced Solid Tumors	NCT05229601	Soft Tissue Sar... Renal Cell Carc... Uterine Carcino... Hepatocellular ... Head and Neck S... Melanoma	HFB301001	18 Years -	HiFiBiO Therapeutics
A Study of HFB301001 in Adult Patients With Advanced Solid Tumors	NCT05229601	Soft Tissue Sar... Renal Cell Carc... Uterine Carcino... Hepatocellular ... Head and Neck S... Melanoma	HFB301001	18 Years -	HiFiBiO Therapeutics

Spots Global Cancer Trial Database for hfb301001

Every month we try and update this database with for hfb301001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hfb301001

Every month we try and update this database with for hfb301001 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hfb301001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.