A Phase 1 interventional study of HFB200603 and Tislelizumab in Renal Cell Carcinoma, Melanoma and Non Small Cell Lung Cancer, sponsored by HiFiBiO Therapeutics. Active, not recruiting at 11 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by HiFiBiO Therapeutics · Phase 1, Interventional, and Treatment
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.
This is a Phase 1a/b, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's planned enrollment of 83 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →HiFiBiO Therapeutics is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient must have one of the following cancers and previously received the following lines of systemic therapy for the advanced/metastatic disease:
Melanoma:
Exclusion Criteria:
Participants will be administered HFB200603 at dose levels 1-4 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).
Drug: HFB200603
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).
Drug: HFB200603 · Drug: Tislelizumab
Participants will be administered HFB200603 at monotherapy RDE as an intravenous infusion.
Drug: HFB200603
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.
Drug: HFB200603 · Drug: Tislelizumab
Participants will be administered HFB200603 as described in the experimental arm.
Participants will be administered tislelizumab as described in the experimental arm.
Also known as: BGB-A317
Number of participants with adverse events (AEs) meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria during Dose Escalation
Severity of adverse events will be based on common terminology criteria for adverse events (CTCAE) version 5.0
Time frame: The first cycle of treatment (Day 1 up to Day 21)
Number of participants with AEs
Severity of AEs will be assessed based on CTCAE version 5.0 (except for cytokine release syndrome which will be assessed by American Society for Transplantation and Cellular Therapy grading)
Time frame: 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
Number of participants with changes in laboratory values
Time frame: 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
Number of participants with changes in vital signs
Time frame: 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
Number of participants with changes in electrocardiogram (ECG)
Time frame: 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
Number of participants with changes in tolerability (dose interruptions and dose intensity)
Time frame: 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
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion
Time frame: 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
Objective Response Rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-RECIST (iRECIST)
Time frame: Baseline to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
Disease Control Rate (DCR) as determined by RECIST 1.1 and iRECIST
Time frame: Baseline to 90 days after the last dose of study drug(s) (each cycle is 21 days), assessed up to 3 years
Duration of Response (DOR) as determined by RECIST 1.1 and iRECIST
Time frame: Start of first response to first date of disease progression, clinical progression or death, whichever occurs first, assessed up to 3 years
Progression Free Survival (PFS) as determined by RECIST 1.1 and iRECIST
Time frame: Baseline to disease progression or death, whichever occurs first, assessed up to 3 years
Minimum serum concentration (Cmin)
Time frame: Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 21 days), through study completion, an average of 3 year
Maximum serum concentration (Cmax)
Time frame: Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 21 days), through study completion, an average of 3 year
Area under the concentration versus time curve (AUC)
Time frame: Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 21 days), through study completion, an average of 3 year
Terminal half-life (T1/2)
Time frame: Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 21 days), through study completion, an average of 3 year
Serum concentration for measurement of anti-HFB200603 antibodies
Time frame: Cycle 1 Day 1 to day of the last dose of study drug(s) (each cycle is 21 days), through study completion, an average of 3 year
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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