A Study of HFB200301 in Adult Patients With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
The purpose of this study is to test the safety and tolerability of HFB200301 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable dose of HFB200301 is determined. During the expansion part, participants will take the dose of study drug 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 |
|---|---|---|
| Phase 1 |
Detailed Description
This is a Phase 1, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of
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A Screening Period of up to 28 days
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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
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A Follow-up Period which involves 1 visit.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HFB200301 - Dose Escalation 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 a starting dose level 1 in Cohort 1. Participants in Cohorts 2-5 will receive increasing dose levels until RDE is established.
|
| Experimental: HFB200301 - Dose Expansion Participants will be administered HFB200301 at RDE as an intravenous infusion. |
Drug: HFB200301
Participants with certain cancer types will be administered the RDE.
|
Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), changes in laboratory values, vital signs and electrocardiogram (ECG) [Cycle 1 Day 1 to 30 days after the last dose of HFB200301 (each cycle is 28 days), assessed up to 3 years]
- To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion [Cycle 1 Day 1 to 30 days after the last dose of HFB200301 (each cycle is 28 days), assessed up to 3 years]
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) [Baseline to 30 days after the last dose of HFB200301 (each cycle is 28 days), assessed up to 3 years]
- Disease Control Rate (DCR) as determined by (m)RECIST 1.1 and iRECIST [Baseline to 30 days after the last dose of HFB200301 (each cycle is 28 days), assessed up to 3 years]
- Duration of Response (DOR) as determined by (m)RECIST 1.1 and iRECIST [Start of first response to first date of disease progression, clinical progression or death, whichever occurs first, assessed up to 3 years]
- Progression Free Survival (PFS) as determined by (m)RECIST 1.1 and iRECIST [Baseline to disease progression or death, whichever occurs first, assessed up to 3 years]
- Minimum serum concentration (Cmin) [Cycle 1 Day 1 to day of the last dose of HFB200301 (each cycle is 28 days), through study completion, an average of 3 year]
- Maximum serum concentration (Cmax) [Cycle 1 Day 1 to day of the last dose of HFB200301 (each cycle is 28 days), through study completion, an average of 3 year]
- Area under the concentration versus time curve (AUC) [Cycle 1 Day 1 to day of the last dose of HFB200301 (each cycle is 28 days), through study completion, an average of 3 year]
- Terminal half-life (T1/2) [Cycle 1 Day 1 to day of the last dose of HFB200301 (each cycle is 28 days), through study completion, an average of 3 year]
- Serum concentration for measurement of anti-HFB200301 antibodies [Cycle 1 Day 1 to day of the last dose of HFB200301 (each cycle is 28 days), through study completion, an average of 3 year]
- To assess the pharmacodynamic (PD) effects of HFB200301 in the blood and in the tumor [Cycle 1 Day 1 to Cycle 3 Day 2 (each cycle is 28 days)]
Percent change in immunologic changes to immune cells in the blood and tumor
Other Outcome Measures
- AUC vs percent of Tcell changes in the blood [Cycle 1 Day 1 to Cycle 4 Day 1 (each cycle is 28 days)]
- AUC vs percent of Tcell changes in the tumor [Cycle 1 Day 1 to Cycle 4 Day 1 (each cycle is 28 days)]
- AUC vs percent change in tumor size [Cycle 1 Day 1 to Cycle 4 Day 1 (each cycle is 28 days)]
- Percent Tcell changes in the blood vs percent change in tumor size [Cycle 1 Day 1 to Cycle 4 Day 1 (each cycle is 28 days)]
- Percent Tcell changes in the tumor vs percent change in tumor size [Cycle 1 Day 1 to Cycle 4 Day 1 (each cycle is 28 days)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Previously received the following lines of systemic therapy for the advanced/metastatic disease:
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Gastric cancer: at least 2 lines of therapy
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Renal cell carcinoma: at least 2 lines of therapy
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Melanoma:
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BRAF V600E mutant: must have received at least 2 lines of therapy
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BRAF V600E wild type: must have received at least 1 line of therapy
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Sarcoma: at least 1 line of therapy
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Testicular germ cell tumor: at least 2 lines of therapy
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Cervical cancer: at least 2 lines of therapy
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Mesothelioma: at least 2 lines of therapy
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Non-small cell lung cancer: at least 3 lines of therapy
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Head and neck squamous cell carcinoma: at least 2 lines of therapy
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Suitable site to biopsy at pre-treatment and on-treatment
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Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST (mRECIST) for mesothelioma
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Eastern Cooperative Oncology Group performance status of 0 or 1
Exclusion Criteria:
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Systemic anti-cancer therapy within 2 weeks prior to start of study drug
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For soft tissue sarcoma and testicular germ cell tumor patients only: prior immune therapy
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Therapeutic radiation therapy within the past 2 weeks
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Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2) receptor
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Active autoimmune disease requiring systemic treatment in the previous 2 years
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Systemic steroid therapy (>10 mg/day of prednisone or equivalent) or any immune suppressive therapy
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Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) relating to prior anti cancer therapy with the following exceptions:
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All grades of alopecia are acceptable
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Endocrine dysfunction on replacement therapy is acceptable
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Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition
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Major surgery within 2 weeks of the first dose of study drug
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History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2
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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
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Using sensitive substrates of major cytochrome P450 (CYP450) enzymes
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Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Scottsdale | Arizona | United States | 85259 |
| 2 | USC/Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033 |
| 3 | Mayo Clinic | Jacksonville | Florida | United States | 32224 |
| 4 | The University of Texas, MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 5 | NEXT Virginia Cancer Specialists | Fairfax | Virginia | United States | 22031 |
Sponsors and Collaborators
- HiFiBiO Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HFB-200301-01
- 2021-006231-25