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

NCT05789069 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: HFB-200603-012022-502891-22-00
• Study Type: interventional
• Target: 83
• Locations: 3 countries
• Sites: 11

Brief 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.

Conditions

Renal Cell Carcinoma; Melanoma; Non Small Cell Lung Cancer; Gastric Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (7)

• 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)

• 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

• 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

Secondary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

Dose Escalation - HFB200603 monotherapy

EXPERIMENTAL

Participants will be administered HFB200603 at dose levels 1-4 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).

Drug: HFB200603

Dose Escalation - HFB200603 in combination with tislelizumab

EXPERIMENTAL

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).

Drug: HFB200603; Drug: Tislelizumab

Dose Expansion - HFB200603 monotherapy (optional)

EXPERIMENTAL

Participants will be administered HFB200603 at monotherapy RDE as an intravenous infusion.

Drug: HFB200603

Dose Expansion - HFB200603 in combination with tislelizumab

EXPERIMENTAL

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.

Drug: HFB200603; Drug: Tislelizumab

Interventions

HFB200603 DRUG

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

Dose Escalation - HFB200603 in combination with tislelizumab; Dose Escalation - HFB200603 monotherapy; Dose Expansion - HFB200603 in combination with tislelizumab; Dose Expansion - HFB200603 monotherapy (optional)

Tislelizumab DRUG

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

Also known as: BGB-A317

Dose Escalation - HFB200603 in combination with tislelizumab; Dose Expansion - HFB200603 in combination with tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HiFiBiO Therapeutics: lead

Study Sites (11)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

New Experimental Therapeutics of Virginia - NEXT Oncology

Fairfax, Virginia, 22031, United States

Location

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, 80131, Italy

Location

UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Centro Ricerche Cliniche di Verona s.r.l.

Verona, 37134, Italy

Location

Clinica Universidad de Navarra - Madrid

Madrid, 28027, Spain

Location

South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC

Madrid, 28050, Spain

Location

Clinica Universidad de Navarra - Pamplona

Pamplona, 31008, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Melanoma; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms; Colorectal Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 29, 2023
• Study Start: May 9, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-03

Locations

US (3); IT (3); ES (5)