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 : May 1, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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
- A Screening Period
- A Treatment Period during which participants will receive the study drug on the first day of each cycle
- A Follow-up Period
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 |
- 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 ]
- To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion [ Time Frame: assessed up to 3 years ]
- Objective Response Rate (ORR) [ Time Frame: assessed up to 3 years ]
- Disease Control Rate (DCR) [ Time Frame: assessed up to 3 years ]
- Duration of Response (DOR) [ Time Frame: assessed up to 3 years ]
- Progression Free Survival (PFS) [ Time Frame: assessed up to 3 years ]
- Maximum serum concentration (Cmax) [ Time Frame: average of 3 years ]
- Terminal half-life (T1/2) [ Time Frame: average of 3 years ]
- Area under the concentration versus time curve (AUC) [ Time Frame: average of 3 years ]
- Serum concentration for measurement of anti-HFB200301 antibodies [ Time Frame: average of 3 years ]
- 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
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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
Contact: Emily Lefkovitz, Clinical Trial Manager | +1(513)579-9911 | e.lefkovitz@Medpace.com |
United States, Arizona | |
Mayo Clinic | Active, not 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 | Active, not 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 |
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: | May 1, 2024 |
Last Verified: | April 2024 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |