Clinical Trials Directory

Trials / Terminated

TerminatedNCT05229601

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

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
31 (actual)
Sponsor
HiFiBiO Therapeutics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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

Conditions

Interventions

TypeNameDescription
DRUGHFB301001Dose 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.

Timeline

Start date
2022-04-20
Primary completion
2024-05-30
Completion
2024-05-30
First posted
2022-02-08
Last updated
2025-10-22

Locations

10 sites across 2 countries: United States, Spain

Regulatory

Source: ClinicalTrials.gov record NCT05229601. Inclusion in this directory is not an endorsement.