A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

Launched by HIFIBIO THERAPEUTICS · Mar 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HFB200603, both on its own and in combination with another medication called tislelizumab, for adult patients with advanced cancers such as renal cell carcinoma, melanoma, non-small cell lung cancer, gastric cancer, and colorectal cancer. The goal is to find out how safe and tolerable this treatment is for patients. The trial has two parts: first, researchers will gradually increase the doses to determine the highest safe dose, and then they will treat participants with the doses found to be safe, grouping them based on their specific type of cancer.

To participate in this trial, patients must have already received certain previous treatments for their cancer. For example, those with renal cell carcinoma must have had at least two prior therapies. Participants will also need to have a specific kind of disease that can be measured and a suitable site for a biopsy before starting treatment. While in the study, patients will receive close monitoring, and they should be prepared for regular check-ups to assess how well the treatment is working and if they can tolerate the medication. It's important for potential participants to know that there are specific health conditions and recent treatments that may prevent them from joining the trial, so discussing eligibility with a healthcare provider is essential.

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Eligibility criteria

• Inclusion Criteria:
• * Patient must have one of the following cancers and previously received the following lines of systemic therapy for the advanced/metastatic disease:
• • Renal cell carcinoma: at least 2 lines of therapy
• • Non-small cell lung cancer: at least 2 lines of therapy
• * Melanoma:
• • BRAF V600E positive: must have received at least 2 lines of therapy
• • BRAF V600E negative: must have received at least 1 line of therapy
• • Gastric cancer: at least 1 line of therapy
• • Colorectal cancer: at least 3 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
• • 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 cytotoxic agents with major delayed toxicity (e.g., mitomycin C), 6 weeks of washout are mandated.
• • Therapeutic radiation therapy within the past 2 weeks
• • Active autoimmune diseases or history of autoimmune disease that may relapse
• • Any malignancy ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively
• • Systemic steroid therapy (\>10 mg/day of prednisone or equivalent) or any immune suppressive medication ≤ 14 days before first dose
• • Patients with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (e.g., alopecia, neuropathy, and specific laboratory abnormalities)
• • Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition
• • Major surgery within 28 days of the first dose of study drug
• • History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis or acute lung diseases. For combination only: non-small cell lung cancer patients, 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 HFB200603 or tislelizumab
• • 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