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

Primary Purpose

Gastric Cancer, Renal Cell Carcinoma, Melanoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
HFB200301
Tislelizumab
Sponsored by
HiFiBiO Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo ClinicRecruiting
  • USC/Norris Comprehensive Cancer CenterRecruiting
  • Mayo ClinicRecruiting
  • Mayo ClinicRecruiting
  • Washington University School of MedicineRecruiting
  • The University of Texas, MD Anderson Cancer Center
  • NEXT Virginia Cancer SpecialistsRecruiting
  • Hospital Universitario Vall d'HebronRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation - HFB200301 monotherapy

Dose Escalation - HFB200301 in combination with tislelizumab

Dose Expansion - HFB200301 monotherapy

Dose Expansion - HFB200301 in combination with tislelizumab

Arm Description

Participants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).

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).

Participants will be administered HFB200301 at monotherapy RDE as an intravenous infusion.

Participations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion.

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), changes in laboratory values, vital signs, electrocardiogram (ECG), and tolerability (dose interruptions, reductions, and dose intensity)
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion

Secondary Outcome Measures

Objective Response Rate (ORR) as determined by (modified) Response Evaluation Criteria in Solid Tumors [(m)RECIST] 1.1 and immune-RECIST (iRECIST)
Disease Control Rate (DCR) as determined by (m)RECIST 1.1 and iRECIST
Duration of Response (DOR) as determined by (m)RECIST 1.1 and iRECIST
Progression Free Survival (PFS) as determined by (m)RECIST 1.1 and iRECIST
Minimum serum concentration (Cmin)
Maximum serum concentration (Cmax)
Area under the concentration versus time curve (AUC)
Terminal half-life (T1/2)
Serum concentration for measurement of anti-HFB200301 antibodies
To assess the pharmacodynamic (PD) effects of HFB200301 as a single agent and in combination in the blood and in the tumor
Percent change in immunologic changes to immune cells in the blood and tumor

Full Information

First Posted
December 16, 2021
Last Updated
May 18, 2023
Sponsor
HiFiBiO Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05238883
Brief Title
A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HiFiBiO Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This is a Phase 1a/b, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of A Screening Period of up to 28 days A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 28 days. Number of cycles depends on how the disease responds to the study drug A Follow-up Period which involves 1 visit for single agent and 2 visits for combination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation - HFB200301 monotherapy
Arm Type
Experimental
Arm Description
Participants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).
Arm Title
Dose Escalation - HFB200301 in combination with tislelizumab
Arm Type
Experimental
Arm Description
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).
Arm Title
Dose Expansion - HFB200301 monotherapy
Arm Type
Experimental
Arm Description
Participants will be administered HFB200301 at monotherapy RDE as an intravenous infusion.
Arm Title
Dose Expansion - HFB200301 in combination with tislelizumab
Arm Type
Experimental
Arm Description
Participations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
HFB200301
Intervention Description
Participants will be administered HFB200301 as described in the experimental arm.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Participants will be administered tislelizumab as described in the experimental arm.
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), changes in laboratory values, vital signs, electrocardiogram (ECG), and tolerability (dose interruptions, reductions, and dose intensity)
Time Frame
Cycle 1 Day 1 to 30 days after the last dose of study drug(s) (each cycle is 28 days), assessed up to 3 years
Title
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion
Time Frame
Cycle 1 Day 1 to 30 days after the last dose of study drug(s) (each cycle is 28 days), assessed up to 3 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) as determined by (modified) Response Evaluation Criteria in Solid Tumors [(m)RECIST] 1.1 and immune-RECIST (iRECIST)
Time Frame
Baseline to 30 days after the last dose of study drug(s) (each cycle is 28 days), assessed up to 3 years
Title
Disease Control Rate (DCR) as determined by (m)RECIST 1.1 and iRECIST
Time Frame
Baseline to 30 days after the last dose of study drug(s) (each cycle is 28 days), assessed up to 3 years
Title
Duration of Response (DOR) as determined by (m)RECIST 1.1 and iRECIST
Time Frame
Start of first response to first date of disease progression, clinical progression or death, whichever occurs first, assessed up to 3 years
Title
Progression Free Survival (PFS) as determined by (m)RECIST 1.1 and iRECIST
Time Frame
Baseline to disease progression or death, whichever occurs first, assessed up to 3 years
Title
Minimum serum concentration (Cmin)
Time Frame
Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 28 days), through study completion, an average of 3 year
Title
Maximum serum concentration (Cmax)
Time Frame
Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 28 days), through study completion, an average of 3 year
Title
Area under the concentration versus time curve (AUC)
Time Frame
Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 28 days), through study completion, an average of 3 year
Title
Terminal half-life (T1/2)
Time Frame
Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 28 days), through study completion, an average of 3 year
Title
Serum concentration for measurement of anti-HFB200301 antibodies
Time Frame
Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 28 days), through study completion, an average of 3 year
Title
To assess the pharmacodynamic (PD) effects of HFB200301 as a single agent and in combination in the blood and in the tumor
Description
Percent change in immunologic changes to immune cells in the blood and tumor
Time Frame
Cycle 1 Day 1 to Cycle 3 Day 2 (each cycle is 28 days)
Other Pre-specified Outcome Measures:
Title
AUC vs percent of Tcell changes in the blood
Time Frame
Cycle 1 Day 1 to Cycle 4 Day 1 (each cycle is 28 days)
Title
AUC vs percent of Tcell changes in the tumor
Time Frame
Cycle 1 Day 1 to Cycle 4 Day 1 (each cycle is 28 days)
Title
AUC vs percent change in tumor size
Time Frame
Cycle 1 Day 1 to Cycle 4 Day 1 (each cycle is 28 days)
Title
Percent Tcell changes in the blood vs percent change in tumor size
Time Frame
Cycle 1 Day 1 to Cycle 4 Day 1 (each cycle is 28 days)
Title
Percent Tcell changes in the tumor vs percent change in tumor size
Time Frame
Cycle 1 Day 1 to Cycle 4 Day 1 (each cycle is 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Lefkovitz, Clinical Trial Manager
Phone
+1(513)579-9911
Email
e.lefkovitz@Medpace.com
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Terminated
Facility Name
NEXT Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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