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Clinical Trial NCT05238883 for 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 is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors Phase 1 72 Combination Therapy
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
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
- HFB-200301-01
- 2021-006231-25 (EudraCT Number)
- 2024-511286-11-00 (EU Study (CTIS) Number)
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalDose 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). | HFB200301 Participants will be administered HFB200301 as described in the experimental arm. |
ExperimentalDose 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). | HFB200301 Participants will be administered HFB200301 as described in the experimental arm. Tislelizumab Participants will be administered tislelizumab as described in the experimental arm. |
ExperimentalDose Expansion - HFB200301 monotherapy Participants will be administered HFB200301 at monotherapy RDE as an intravenous infusion. | HFB200301 Participants will be administered HFB200301 as described in the experimental arm. |
ExperimentalDose Expansion - HFB200301 in combination with tislelizumab Participations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion. | HFB200301 Participants will be administered HFB200301 as described in the experimental arm. Tislelizumab Participants will be administered tislelizumab as described in the experimental arm. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), and tolerability (dose interruptions, reductions, and dose intensity) | assessed up to 3 years | |
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion | assessed up to 3 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective Response Rate (ORR) | assessed up to 3 years | |
Disease Control Rate (DCR) | assessed up to 3 years | |
Duration of Response (DOR) | assessed up to 3 years | |
Progression Free Survival (PFS) | assessed up to 3 years | |
Maximum serum concentration (Cmax) | average of 3 years | |
Terminal half-life (T1/2) | average of 3 years | |
Area under the concentration versus time curve (AUC) | average of 3 years | |
Serum concentration for measurement of anti-HFB200301 antibodies | average of 3 years | |
To assess the pharmacodynamic (PD) effects of HFB200301 as a single agent and in combination | Percent change in immunologic changes to immune cells | average of 3 years |
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
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.
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