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HFB200603 + Tislelizumab for Advanced Cancers
Phase 1
Recruiting
Research Sponsored by HiFiBiO Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group performance status of 0 or 1
Patient must have one of the following cancers and previously received the specified lines of 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: at least 2 lines of therapy, BRAF V600E negative: at least 1 line of therapy), Gastric cancer (at least 1 line of therapy), Colorectal cancer (at least 3 lines of therapy)
Must not have
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
Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the safety and effectiveness of two cancer treatments, HFB200603 and tislelizumab, in patients with advanced cancers.
Who is the study for?
Adults with certain advanced cancers (stomach, lung, colorectal, kidney cancer, melanoma) who've had specific prior treatments can join. They need a site for biopsy and measurable disease by RECIST 1.1 standards. A good performance status is required (0 or 1), and they must not have had recent cancer therapy or major surgery, no active autoimmune diseases or severe medical conditions.
What is being tested?
The trial tests HFB200603 alone and with Tislelizumab in two parts: dose-escalation to find safe levels and expansion where those doses are given based on the participant's cancer type. The goal is to determine safety and tolerability of these drugs in combination or as monotherapy.
What are the potential side effects?
Potential side effects may include reactions similar to other monoclonal antibodies such as immune-related issues, infusion reactions like CRS, organ inflammation, fatigue, digestive problems; specifics will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I have a specific cancer type and have received the required number of treatments for it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had any cancer other than the one being studied in the last 5 years.
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I do not have severe diabetes, bleeding disorders, or uncontrolled mental health conditions.
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I have a history of serious lung conditions or currently need extra oxygen.
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I have not had radiation therapy in the last 2 weeks.
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I have not had major surgery in the last 4 weeks.
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I haven't had cancer treatment in the last 2-6 weeks, depending on the type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with AEs
Number of participants with adverse events (AEs) meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria during Dose Escalation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose Expansion - HFB200603 monotherapy (optional)Experimental Treatment1 Intervention
Participants will be administered HFB200603 at monotherapy RDE as an intravenous infusion.
Group II: Dose Expansion - HFB200603 in combination with tislelizumabExperimental Treatment2 Interventions
Participants will be administered HFB200603 in combination with tislelizumab at combination RDEs as an intravenous infusion. Based on the cancer type, participants will be randomized to combination HFB200603 RDE 1 or RDE 2.
Group III: Dose Escalation - HFB200603 monotherapyExperimental Treatment1 Intervention
Participants will be administered HFB200603 at dose levels 1-4 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).
Group IV: Dose Escalation - HFB200603 in combination with tislelizumabExperimental Treatment2 Interventions
Participants will be administered HFB200603 at dose levels 1-3 in combination with one dose level of tislelizumab as an intravenous infusion to determine the combination Recommended Doses for Expansion (RDEs).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4730
Find a Location
Who is running the clinical trial?
HiFiBiO TherapeuticsLead Sponsor
4 Previous Clinical Trials
298 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I do not have severe diabetes, bleeding disorders, or uncontrolled mental health conditions.My side effects from previous cancer treatments have mostly gone away or stabilized, except for things like hair loss or numbness.You have a current autoimmune disease or a history of an autoimmune disease that could come back.I haven't had any cancer other than the one being studied in the last 5 years.I have a history of serious lung conditions or currently need extra oxygen.I can have a biopsy before and during treatment.You have a tumor that can be measured using specific guidelines called RECIST 1.1.You have previously participated in a study using tislelizumab until certain important results from that study are known.I have not had radiation therapy in the last 2 weeks.I have a specific cancer type and have received the required number of treatments for it.I have not had major surgery in the last 4 weeks.I haven't had cancer treatment in the last 2-6 weeks, depending on the type.I haven't taken high-dose steroids or immune suppressants in the last 2 weeks.You have had allergic reactions or immune-related reactions to drugs similar to monoclonal antibodies or the study drugs HFB200603 or tislelizumab.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation - HFB200603 monotherapy
- Group 2: Dose Escalation - HFB200603 in combination with tislelizumab
- Group 3: Dose Expansion - HFB200603 monotherapy (optional)
- Group 4: Dose Expansion - HFB200603 in combination with tislelizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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