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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05789069
• Other study ID #: HFB-200603-01
• Status: Recruiting
• Phase: Phase 1
• Start date: May 9, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: HiFiBiO Therapeutics
• Contact: Edward Steele, Clinical Trial Manager
• Phone: (513)579-9911
• Email: e.steele[@]medpace.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a Phase 1a/b, first in human, open-label, dose escalation and expansion study in adults 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 21 days. Number of cycles depends on how the disease responds to the study drug 3. A Follow-up Period which involves 2 visits

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 83
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Colorectal Cancer
• Gastric Cancer
• Melanoma
• Non Small Cell Lung Cancer
• Renal Cell Carcinoma

Intervention

Drug:
• HFB200603
Participants will be administered HFB200603 as described in the experimental arm.
• Tislelizumab
Participants will be administered tislelizumab as described in the experimental arm.

Locations

Country	Name	City	State
Italy	Istituto Nazionale Tumori IRCCS Fondazione G. Pascale	Napoli
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
Spain	Clinica Universidad de Navarra - Madrid	Madrid
Spain	South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC	Madrid
Spain	South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz	Madrid
Spain	Clinica Universidad de Navarra - Pamplona	Pamplona
Spain	Hospital Clinico Universitario de Valencia	Valencia
United States	New Experimental Therapeutics of Virginia - NEXT Oncology	Fairfax	Virginia
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
HiFiBiO Therapeutics

Countries where clinical trial is conducted

United States,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs) meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria during Dose Escalation	Severity of adverse events will be based on common terminology criteria for adverse events (CTCAE) version 5.0	The first cycle of treatment (Day 1 up to Day 21)
Primary	Number of participants with AEs	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)	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Objective Response Rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-RECIST (iRECIST)		Baseline to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
Secondary	Disease Control Rate (DCR) as determined by RECIST 1.1 and iRECIST		Baseline to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
Secondary	Duration of Response (DOR) as determined by RECIST 1.1 and iRECIST		Start of first response to first date of disease progression, clinical progression or death, whichever occurs first, assessed up to 3 years
Secondary	Progression Free Survival (PFS) as determined by RECIST 1.1 and iRECIST		Baseline to disease progression or death, whichever occurs first, assessed up to 3 years
Secondary	Minimum serum concentration (Cmin)		Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 21 days), through study completion, an average of 3 year
Secondary	Maximum serum concentration (Cmax)		Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 21 days), through study completion, an average of 3 year
Secondary	Area under the concentration versus time curve (AUC)		Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 21 days), through study completion, an average of 3 year
Secondary	Terminal half-life (T1/2)		Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 21 days), through study completion, an average of 3 year
Secondary	Serum concentration for measurement of anti-HFB200603 antibodies		Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 21 days), through study completion, an average of 3 year