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, Italy83 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 range18 Years
SexALL
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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…
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