Renal Cell CarcinomaPhase 1NCT05789069
A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing HFB200603 and Tislelizumab in people with Renal Cell Carcinoma and Melanoma, run by HiFiBiO Therapeutics at 11 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Melanoma, Non Small Cell Lung Cancer
- What is being tested?
- HFB200603 and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 9 May 2023to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (e.g., alopecia, neuropathy, and specific laboratory abnormalities)
Show all 11Show fewer
- Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition
- Major surgery within 28 days of the first dose of study drug
- History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis or acute lung diseases. For combination only: non-small cell lung cancer patients, or patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening
- History of allergic reactions, immune related reactions, or cytokine release syndrome (CRS) attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB200603 or tislelizumab
- For combination only: Prior randomization in a tislelizumab study regardless of the treatment arm, until the primary and key secondary endpoints of the study have read out
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Spain5 sites
Clinica Universidad de Navarra - Madrid
Madrid, 28027
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, 28040
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, 28050
Clinica Universidad de Navarra - Pamplona
Pamplona, 31008
Hospital Clinico Universitario de Valencia
Valencia, 46010
United States3 sites
New Experimental Therapeutics of Virginia - NEXT Oncology
Fairfax, Virginia, 22031
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Italy3 sites
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, 80131
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, 00168
Centro Ricerche Cliniche di Verona s.r.l.
Verona, 37134
About this study
Official title: A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200603 (Anti-BTLA Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors
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.
Read the detailed description
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
- A Screening Period of up to 28 days
- A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 21 days. Number of cycles depends on how the disease responds to the study drug
- A Follow-up Period which involves 2 visits
- Conditions
- Renal Cell Carcinoma, Melanoma, Non Small Cell Lung Cancer, Gastric Cancer, Colorectal Cancer
- Being tested
- HFB200603, Tislelizumab
- Medical subject headings
- Carcinoma, Renal Cell, Melanoma, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFB200603Drug
Participants will be administered HFB200603 as described in the experimental arm.
TislelizumabDrug
Also called BGB-A317
Participants will be administered tislelizumab as described in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation - HFB200603 monotherapy | Experimental | Participants will be administered HFB200603 at dose levels 1-4 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE). Receives: Drug: HFB200603 |
| Dose Escalation - HFB200603 in combination with tislelizumab | Experimental | 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). Receives: Drug: HFB200603; Drug: Tislelizumab |
| Dose Expansion - HFB200603 monotherapy (optional) | Experimental | Participants will be administered HFB200603 at monotherapy RDE as an intravenous infusion. Receives: Drug: HFB200603 |
| Dose Expansion - HFB200603 in combination with tislelizumab | Experimental | 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. Receives: Drug: HFB200603; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Secondary outcomes (9)
Objective Response Rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-RECIST (iRECIST)
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to disease progression or death, whichever occurs first, assessed up to 3 years
Minimum serum concentration (Cmin)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start9 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HiFiBiO Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789069
- Sponsor's protocol ID
- HFB-200603-01
- Other IDs
- 2022-502891-22-00
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2023
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200603 (Anti-BTLA Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05789069
- Acronym / sponsor ID
- HFB-200603-01
- Conditions
- Renal Cell Carcinoma, Melanoma, Non Small Cell Lung Cancer, Gastric Cancer, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- HiFiBiO TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- A Screening Period of up to 28 days
- A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 21 days. Number of cycles depends on how the disease responds to the study drug
- A Follow-up Period which involves 2 visits
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation - HFB200603 monotherapy | Experimental | Drug: HFB200603Participants will be administered HFB200603 at dose levels 1-4 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE). |
| Dose Escalation - HFB200603 in combination with tislelizumab | Experimental | Drug: HFB200603, Drug: TislelizumabParticipants 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). |
| Dose Expansion - HFB200603 monotherapy (optional) | Experimental | Drug: HFB200603Participants will be administered HFB200603 at monotherapy RDE as an intravenous infusion. |
| Dose Expansion - HFB200603 in combination with tislelizumab | Experimental | Drug: HFB200603, Drug: TislelizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient must have one of the following cancers and previously received the following lines of systemic therapy for the advanced/metastatic disease:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFB200603Participants will be administered HFB200603 as described in the experimental arm. | Drug | Dose Escalation - HFB200603 in combination with tislelizumab, Dose Escalation - HFB200603 monotherapy, Dose Expansion - HFB200603 in combination with tislelizumab, Dose Expansion - HFB200603 monotherapy (optional) |
| TislelizumabAlso: BGB-A317Participants will be administered tislelizumab as described in the experimental arm. | Drug | Dose Escalation - HFB200603 in combination with tislelizumab, Dose Expansion - HFB200603 in combination with tislelizumab |
Primary outcome
Number of participants with adverse events (AEs) meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria during Dose Escalation
Time frame: The first cycle of treatment (Day 1 up to Day 21)
Severity of adverse events will be based on common terminology criteria for adverse events (CTCAE) version 5.0
Number of participants with AEs
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
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)
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HFB200603 and Tislelizumab in people with Renal Cell Carcinoma and Melanoma, run by HiFiBiO Therapeutics at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria during Dose Escalation (time frame: The first cycle of treatment (Day 1 up to Day 21)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.