ACTIVE_NOT_RECRUITING

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

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Conditions

Renal Cell CarcinomaMelanomaNon Small Cell Lung CancerGastric CancerColorectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-05-09
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05789069

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must have one of the following cancers and previously received the following lines of systemic therapy for the advanced/metastatic disease:
  2. * Renal cell carcinoma: at least 2 lines of therapy
  3. * Non-small cell lung cancer: at least 2 lines of therapy
  4. * Melanoma:
  5. * BRAF V600E positive: must have received at least 2 lines of therapy
  6. * BRAF V600E negative: must have received at least 1 line of therapy
  7. * Gastric cancer: at least 1 line of therapy
  8. * Colorectal cancer: at least 3 lines of therapy
  9. * Suitable site to biopsy at pre-treatment and on-treatment
  10. * Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  11. * Eastern Cooperative Oncology Group performance status of 0 or 1
  1. * 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.
  2. * Therapeutic radiation therapy within the past 2 weeks
  3. * Active autoimmune diseases or history of autoimmune disease that may relapse
  4. * 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
  5. * Systemic steroid therapy (\>10 mg/day of prednisone or equivalent) or any immune suppressive medication ≤ 14 days before first dose
  6. * 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)
  7. * Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition
  8. * Major surgery within 28 days of the first dose of study drug
  9. * 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
  10. * 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
  11. * 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

Contacts and Locations

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
New Experimental Therapeutics of Virginia - NEXT Oncology
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: HiFiBiO Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-09
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-05-09
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

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