A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) in Adult Patients With Advanced Solid Tumors

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to test the safety and tolerability of HFB200301 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 dose of HFB200301 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 the participants have.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Previously received the following lines of systemic therapy for the advanced/metastatic disease:

• Gastric cancer: at least 2 lines of therapy

• Renal cell carcinoma: at least 2 lines of therapy

• Melanoma:

• BRAF V600E mutant: must have received at least 2 lines of therapy

• BRAF V600E wild type: must have received at least 1 line of therapy

• Sarcoma: at least 1 line of therapy

• Testicular germ cell tumor: at least 2 lines of therapy

• Cervical cancer: at least 2 lines of therapy

• Mesothelioma: at least 2 lines of therapy

• Non-small cell lung cancer: at least 3 lines of therapy

• Head and neck squamous cell carcinoma: at least 2 lines of therapy

• Suitable site to biopsy at pre-treatment and on-treatment

• Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST (mRECIST) for mesothelioma

• Eastern Cooperative Oncology Group performance status of 0 or 1

Locations
United States
Arizona
Mayo Clinic
Recruiting
Scottsdale
California
USC/Norris Comprehensive Cancer Center
Recruiting
Los Angeles
Florida
Mayo Clinic
Recruiting
Jacksonville
Minnesota
Mayo Clinic
Recruiting
Rochester
Missouri
Washington University School of Medicine
Recruiting
Saint Louis
Texas
The University of Texas, MD Anderson Cancer Center
Recruiting
Houston
Virginia
NEXT Virginia Cancer Specialists
Recruiting
Fairfax
Other Locations
Spain
Hospital Universitario Vall d'Hebron
Recruiting
Barcelona
Hospital Universitario 12 de Octubre
Recruiting
Madrid
Hospital Clinico Universitario de Valencia
Recruiting
Valencia
Contact Information
Primary
Emily Lefkovitz, Clinical Trial Manager
e.lefkovitz@Medpace.com
+1(513)579-9911
Time Frame
Start Date: March 10, 2022
Estimated Completion Date: January 2024
Participants
Target number of participants: 90
Treatments
Experimental: HFB200301 - Dose Escalation
Participants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).
Experimental: HFB200301 - Dose Expansion
Participants will be administered HFB200301 at RDE as an intravenous infusion.
Sponsors
Leads: HiFiBiO Therapeutics

This content was sourced from clinicaltrials.gov

Similar Clinical Trials