A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients Wit… (NCT05789069) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors
United States, Italy, Spain83 participantsStarted 2023-05-09
Plain-language summary
The purpose of this study is to test the safety and tolerability of HFB200603 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 HFB200603 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200603 as a single agent or combination therapy is determined. During the expansion part, participants will take the doses of HFB200603 as a monotherapy (optional arm) or in combination with tislelizumab that were determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 toxicitie…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the right dose and measuring side effects rather than proving the treatment works, what does that mean for my personal risk compared to standard treatment options for my specific cancer?
2The trial is listed as 'active but no longer recruiting' — does that mean it's completely closed to new patients, or is there any circumstance where my doctor could still explore enrollment for me?
3One of the main things this study is measuring is dose-limiting toxicities — meaning side effects serious enough to cap the dose — so what kinds of side effects have been seen so far with HFB200603, especially when combined with the immunotherapy tislelizumab?
4Because this trial involves both a new experimental drug and an immunotherapy combination, how would my doctor monitor me for overlapping side effects, and how would that affect my other treatment options if things don't go well?
5Given that my cancer type is one of the five being studied here, would my doctor consider this trial only after standard treatments have been tried, or could it be worth discussing as an earlier option in my care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AEs) meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria during Dose Escalation
Timeframe: The first cycle of treatment (Day 1 up to Day 21)
2
Number of participants with AEs
Timeframe: Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
3
Number of participants with changes in laboratory values
Timeframe: Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
4
Number of participants with changes in vital signs
Timeframe: Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
5
Number of participants with changes in electrocardiogram (ECG)
Timeframe: Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
6
Number of participants with changes in tolerability (dose interruptions and dose intensity)
Timeframe: Cycle 1 Day 1 to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years