A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients Wit… (NCT05238883) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors
United States, Spain72 participantsStarted 2022-03-10
Plain-language 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.
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:
* 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 prednison…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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), serious AEs (SAEs), dose-limiting toxicities (DLTs), and tolerability (dose interruptions, reductions, and dose intensity)
Timeframe: assessed up to 3 years
2
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion