A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

NCT05789069 · tracked via the Priya Life Science USA tracker

Sponsor

HiFiBiO Therapeutics

Phase

Phase 1

Started

2023-05-09

Last updated

2026-06-08

Condition(s) studied

Renal Cell CarcinomaMelanomaNon Small Cell Lung CancerGastric CancerColorectal Cancer

Investigational drug(s) / intervention(s)

HFB200603Tislelizumab

HFB200603: Participants will be administered HFB200603 as described in the experimental arm.

Tislelizumab: Participants will be administered tislelizumab as described in the experimental arm.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * Systemic anti-cancer therapy within 2 weeks prior to start of study drug or within 4 weeks for immune-oncologic therapy. For cytotoxic agents with major delayed toxicity (e.g., mitomycin C), 6 weeks of washout are mandated. * Therapeutic radiation therapy within the past 2 weeks * Active autoimmune diseases or history of autoimmune disease that may relapse * Any malignancy ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively * Systemic steroid therapy (\>10 mg/day of prednisone or equivalent) or any immune suppressive medication ≤ 14 days before first dose * Patients with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (e.g., alopecia, neuropathy, and specific laboratory abnormalities) * Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition * Major surgery within 28 days of the first dose of study drug * History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis or acute lung diseases. For combination only: non-small cell lung cancer patients, or patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening * History of allergic reactions, immune related reactions, or cytokine release syndrome (CRS) attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB200603 or tislelizumab * For combination only: Prior randomization in a tislelizumab study regardless of the treatment arm, until the primary and key secondary endpoints of the study have read out

Primary outcome measure(s)

Number of participants with adverse events (AEs) meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria during Dose Escalation — The first cycle of treatment (Day 1 up to Day 21)
Severity of adverse events will be based on common terminology criteria for adverse events (CTCAE) version 5.0
Number of participants with AEs — Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
Severity of AEs will be assessed based on CTCAE version 5.0 (except for cytokine release syndrome which will be assessed by American Society for Transplantation and Cellular Therapy grading)
Number of participants with changes in laboratory values — Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
Number of participants with changes in vital signs — Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
Number of participants with changes in electrocardiogram (ECG) — Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
Number of participants with changes in tolerability (dose interruptions and dose intensity) — Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion — Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years

Trial sites (11)

Facility	City	Region
USC Norris Comprehensive Cancer Center	Los Angeles	California
Fox Chase Cancer Center	Philadelphia	Pennsylvania
New Experimental Therapeutics of Virginia - NEXT Oncology	Fairfax	Virginia
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale	Naples	Italy
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore	Rome	Italy
Centro Ricerche Cliniche di Verona s.r.l.	Verona	Italy
Clinica Universidad de Navarra - Madrid	Madrid	Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz	Madrid	Spain
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC	Madrid	Spain
Clinica Universidad de Navarra - Pamplona	Pamplona	Spain
Hospital Clinico Universitario de Valencia	Valencia	Spain

More HiFiBiO Therapeutics trials in the USA

A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors Active, not recruiting

Other trials for the same condition

A Phase 1/2 Study of BA3071 in Patients With Solid Tumors Active, not recruiting

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors Recruiting

This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors Recruiting

A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1) Recruiting

ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05789069 on ClinicalTrials.gov ↗ ← All trials in the USA