This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05238883
Recruitment Status : Recruiting
First Posted : February 14, 2022
Last Update Posted : December 21, 2023
Sponsor:
Information provided by (Responsible Party):
HiFiBiO Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Drug: HFB200301 Drug: Tislelizumab Phase 1

Detailed Description:

This is a Phase 1a/1b, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of

  1. A Screening Period
  2. A Treatment Period during which participants will receive the study drug on the first day of each cycle
  3. A Follow-up Period

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2022
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026


Arm Intervention/treatment
Experimental: Dose Escalation - HFB200301 monotherapy
Participants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).
Drug: HFB200301
Participants will be administered HFB200301 as described in the experimental arm.

Experimental: Dose Escalation - HFB200301 in combination with tislelizumab
Participants will be administered HFB200301 at dose levels 1-4 in combination with one dose level of tislelizumab as an intravenous infusion to determine the combination Recommended Dose for Expansion (RDE).
Drug: HFB200301
Participants will be administered HFB200301 as described in the experimental arm.

Drug: Tislelizumab
Participants will be administered tislelizumab as described in the experimental arm.
Other Name: BGB-A317

Experimental: Dose Expansion - HFB200301 monotherapy
Participants will be administered HFB200301 at monotherapy RDE as an intravenous infusion.
Drug: HFB200301
Participants will be administered HFB200301 as described in the experimental arm.

Experimental: Dose Expansion - HFB200301 in combination with tislelizumab
Participations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion.
Drug: HFB200301
Participants will be administered HFB200301 as described in the experimental arm.

Drug: Tislelizumab
Participants will be administered tislelizumab as described in the experimental arm.
Other Name: BGB-A317




Primary Outcome Measures :
  1. Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), and tolerability (dose interruptions, reductions, and dose intensity) [ Time Frame: assessed up to 3 years ]
  2. To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion [ Time Frame: assessed up to 3 years ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: assessed up to 3 years ]
  2. Disease Control Rate (DCR) [ Time Frame: assessed up to 3 years ]
  3. Duration of Response (DOR) [ Time Frame: assessed up to 3 years ]
  4. Progression Free Survival (PFS) [ Time Frame: assessed up to 3 years ]
  5. Maximum serum concentration (Cmax) [ Time Frame: average of 3 years ]
  6. Terminal half-life (T1/2) [ Time Frame: average of 3 years ]
  7. Area under the concentration versus time curve (AUC) [ Time Frame: average of 3 years ]
  8. Serum concentration for measurement of anti-HFB200301 antibodies [ Time Frame: average of 3 years ]
  9. To assess the pharmacodynamic (PD) effects of HFB200301 as a single agent and in combination [ Time Frame: average of 3 years ]
    Percent change in immunologic changes to immune cells



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously received the following lines of systemic therapy for the advanced/metastatic disease:

    • Gastric cancer: at least 2 lines of therapy
    • Renal cell carcinoma: at least 2 lines of therapy
    • Melanoma:

      • BRAF V600E mutant: must have received at least 2 lines of therapy
      • BRAF V600E wild type: must have received at least 1 line of therapy
    • Sarcoma: at least 1 line of therapy
    • Testicular germ cell tumor: at least 2 lines of therapy
    • Cervical cancer: at least 2 lines of therapy
    • Mesothelioma: at least 2 lines of therapy
    • Non-small cell lung cancer: at least 2 lines of therapy
    • Head and neck squamous cell carcinoma: at least 2 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 or modified RECIST (mRECIST) for mesothelioma
  • 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 soft tissue sarcoma and testicular germ cell tumor patients only: prior immune therapy
  • Therapeutic radiation therapy within the past 2 weeks
  • Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2) receptor
  • Active autoimmune disease requiring systemic treatment in the previous 2 years
  • Systemic steroid therapy (>10 mg/day of prednisone or equivalent) or any immune suppressive therapy ≤ 14 days before first dose
  • Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) relating to prior anti cancer therapy with the following exceptions:

    • All grades of alopecia are acceptable
    • Endocrine dysfunction on replacement therapy is acceptable
  • Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition
  • Major surgery within 4 weeks of the first dose of study drug
  • 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
  • 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
  • Using sensitive substrates of major cytochrome P450 (CYP450) enzymes
  • Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years
  • 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
    • Hypersensitivity to tislelizumab or any of its excipients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05238883


Contacts
Layout table for location contacts
Contact: Emily Lefkovitz, Clinical Trial Manager +1(513)579-9911 e.lefkovitz@Medpace.com

Locations
Layout table for location information
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
United States, California
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, Texas
The University of Texas, MD Anderson Cancer Center Terminated
Houston, Texas, United States, 77030
United States, Virginia
NEXT Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Spain
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Sponsors and Collaborators
HiFiBiO Therapeutics
Layout table for additonal information
Responsible Party: HiFiBiO Therapeutics
ClinicalTrials.gov Identifier: NCT05238883    
Other Study ID Numbers: HFB-200301-01
2021-006231-25 ( EudraCT Number )
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: December 21, 2023
Last Verified: December 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Mesothelioma
Neoplasms, Germ Cell and Embryonal
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Adenoma
Neoplasms, Mesothelial
Head and Neck Neoplasms
Tislelizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents