A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200603 (Anti-BTLA Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors
Status: Recruiting
Location: See all (11) 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 HFB200603 as a single agent and in combination with tislelizumab in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses of HFB200603 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200603 as a single agent or combination therapy is determined. During the expansion part, participants will take the doses of HFB200603 as a monotherapy (optional arm) or in combination with tislelizumab that were 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: f
View:
• Patient must have one of the following cancers and previously received the following lines of systemic therapy for the advanced/metastatic disease:
‣ Renal cell carcinoma: at least 2 lines of therapy
⁃ Non-small cell lung cancer: at least 2 lines of therapy
⁃ Melanoma:
• BRAF V600E positive: must have received at least 2 lines of therapy
∙ BRAF V600E negative: must have received at least 1 line of therapy
⁃ Gastric cancer: at least 1 line of therapy
⁃ Colorectal cancer: at least 3 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
• Eastern Cooperative Oncology Group performance status of 0 or 1
Locations
United States
California
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Pennsylvania
Fox Chase Cancer Center
TERMINATED
Philadelphia
Virginia
New Experimental Therapeutics of Virginia - NEXT Oncology
TERMINATED
Fairfax
Other Locations
Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
TERMINATED
Napoli
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
RECRUITING
Rome
Centro Ricerche Cliniche di Verona s.r.l.
RECRUITING
Verona
Spain
Clinica Universidad de Navarra - Madrid
RECRUITING
Madrid
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
RECRUITING
Madrid
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Participants will be administered HFB200603 at dose levels 1-4 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).
Experimental: Dose Escalation - HFB200603 in combination with tislelizumab
Participants will be administered HFB200603 at dose levels 1-3 in combination with one dose level of tislelizumab as an intravenous infusion to determine the combination Recommended Doses for Expansion (RDEs).
Participants will be administered HFB200603 at monotherapy RDE as an intravenous infusion.
Experimental: Dose Expansion - HFB200603 in combination with tislelizumab
Participants will be administered HFB200603 in combination with tislelizumab at combination RDEs as an intravenous infusion. Based on the cancer type, participants will be randomized to combination HFB200603 RDE 1 or RDE 2.