ACTIVE_NOT_RECRUITING

A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

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 HFB200301 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 HFB200301 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200301 as a single agent or combination therapy is determined. During the expansion part, participants will take the dose of HFB200301 as a monotherapy or in combination with tislelizumab that was 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 HFB200301 (TNFR2 Agonist 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:2022-03-10
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05238883

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. * Previously received the following lines of systemic therapy for the advanced/metastatic disease:
  2. * Gastric cancer: at least 2 lines of therapy
  3. * Renal cell carcinoma: at least 2 lines of therapy
  4. * Melanoma:
  5. * BRAF V600E mutant: must have received at least 2 lines of therapy
  6. * BRAF V600E wild type: must have received at least 1 line of therapy
  7. * Sarcoma: at least 1 line of therapy
  8. * Testicular germ cell tumor: at least 2 lines of therapy
  9. * Cervical cancer: at least 2 lines of therapy
  10. * Mesothelioma: at least 2 lines of therapy
  11. * Non-small cell lung cancer: at least 2 lines of therapy
  12. * Head and neck squamous cell carcinoma: at least 2 lines of therapy
  13. * Suitable site to biopsy at pre-treatment and on-treatment
  14. * Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST (mRECIST) for mesothelioma
  15. * 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
  2. * For soft tissue sarcoma and testicular germ cell tumor patients only: prior immune therapy
  3. * Therapeutic radiation therapy within the past 2 weeks
  4. * Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2) receptor
  5. * Active autoimmune disease requiring systemic treatment in the previous 2 years
  6. * Systemic steroid therapy (\>10 mg/day of prednisone or equivalent) or any immune suppressive therapy ≤ 14 days before first dose
  7. * Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) relating to prior anti cancer therapy with the following exceptions:
  8. * All grades of alopecia are acceptable
  9. * Endocrine dysfunction on replacement therapy is acceptable
  10. * Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition
  11. * Major surgery within 4 weeks of the first dose of study drug
  12. * History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2. For combination only: non-small cell lung cancer patients, mesothelioma or patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening
  13. * 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 HFB200301
  14. * Using sensitive substrates of major cytochrome P450 (CYP450) enzymes
  15. * Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years
  16. * For combination only:
  17. * Prior randomization in a tislelizumab study regardless of the treatment arm, until the primary and key secondary endpoints of the study have read out
  18. * Hypersensitivity to tislelizumab or any of its excipients.

Contacts and Locations

Study Locations (Sites)

Mayo Clinic
Scottsdale, Arizona, 85259
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Virginia Cancer Specialists
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 Date2022-03-10
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-03-10
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Gastric Cancer
  • Renal Cell Carcinoma
  • Melanoma
  • Sarcoma
  • Testicular Germ Cell Tumor
  • Cervical Cancer
  • Mesothelioma
  • Non Small Cell Lung Cancer
  • Head and Neck Squamous Cell Carcinoma