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Gastric CancerPhase 1NCT05238883

A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

A Phase 1 study testing HFB200301 and Tislelizumab in people with Gastric Cancer and Renal Cell Carcinoma, run by HiFiBiO Therapeutics at 10 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Renal Cell Carcinoma, Melanoma
What is being tested?
HFB200301 and Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
10 sitesin 2 countries
Study dates
10 Mar 2022to 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

  • 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
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  • 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

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 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 prednisone or equivalent) or any immune suppressive therapy ≤ 14 days before first dose
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  • Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) relating to prior anti cancer therapy with the following exceptions:
  • All grades of alopecia are acceptable
  • Endocrine dysfunction on replacement therapy is acceptable
  • Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition
  • Major surgery within 4 weeks of the first dose of study drug
  • History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2. For combination only: non-small cell lung cancer patients, mesothelioma 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 HFB200301
  • Using sensitive substrates of major cytochrome P450 (CYP450) enzymes
  • Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years
  • 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
  • Hypersensitivity to tislelizumab or any of its excipients.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States7 sites

  • NEXT Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Spain3 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

About this study

Official title: A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist 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 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.

Read the detailed description

This is a Phase 1a/1b, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of

  1. A Screening Period
  2. A Treatment Period during which participants will receive the study drug on the first day of each cycle
  3. A Follow-up Period
Being tested
HFB200301, Tislelizumab
Medical subject headings
Stomach Neoplasms, Carcinoma, Renal Cell, Melanoma, Sarcoma, Testicular Germ Cell Tumor, Uterine Cervical Neoplasms, Mesothelioma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFB200301Drug

    Participants will be administered HFB200301 as described in the experimental arm.

  • TislelizumabDrug

    Also called BGB-A317

    Participants will be administered tislelizumab as described in the experimental arm.

Study groups in NCT05238883
Study groupRoleWhat they receive
Dose Escalation - HFB200301 monotherapyExperimentalParticipants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).
Receives: Drug: HFB200301
Dose Escalation - HFB200301 in combination with tislelizumabExperimentalParticipants will be administered HFB200301 at dose levels 1-4 in combination with one dose level of tislelizumab as an intravenous infusion to determine the combination Recommended Dose for Expansion (RDE).
Receives: Drug: HFB200301; Drug: Tislelizumab
Dose Expansion - HFB200301 monotherapyExperimentalParticipants will be administered HFB200301 at monotherapy RDE as an intravenous infusion.
Receives: Drug: HFB200301
Dose Expansion - HFB200301 in combination with tislelizumabExperimentalParticipations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion.
Receives: Drug: HFB200301; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), and tolerability (dose interruptions, reductions, and dose intensity)

    Measured: assessed up to 3 years

  2. To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion

    Measured: assessed up to 3 years

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    Measured: assessed up to 3 years

  2. Disease Control Rate (DCR)

    Measured: assessed up to 3 years

  3. Duration of Response (DOR)

    Measured: assessed up to 3 years

  4. Progression Free Survival (PFS)

    Measured: assessed up to 3 years

  5. Maximum serum concentration (Cmax)

    Measured: average of 3 years

  6. Terminal half-life (T1/2)

    Measured: average of 3 years

  7. Area under the concentration versus time curve (AUC)

    Measured: average of 3 years

  8. Serum concentration for measurement of anti-HFB200301 antibodies

    Measured: average of 3 years

  9. To assess the pharmacodynamic (PD) effects of HFB200301 as a single agent and in combination

    Percent change in immunologic changes to immune cells

    Measured: average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start10 Mar 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05238883
Sponsor's protocol ID
HFB-200301-01
Other IDs
2021-006231-25, 2024-511286-11-00
Status last verified
Nov 2025
First submitted
16 Dec 2021
Last updated
21 Nov 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gao Z, Zhang Q, Chen H, Chen J, Kang J, Yu H, Song Y, Zhang X. TNFR2 promotes pancreatic cancer proliferation, migration, and invasion via the NF-kappaB signaling pathway. Aging (Albany NY). 2023 Aug 16;15(16):8013-8025. doi: 10.18632/aging.204941. Epub 2023 Aug 16.

    PubMed 37589506

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HFB200301 and Tislelizumab in people with Gastric Cancer and Renal Cell Carcinoma, run by HiFiBiO Therapeutics at 10 sites in 2 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 15 inclusion and 18 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Spain. 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), serious AEs (SAEs), dose-limiting toxicities (DLTs), and tolerability (dose interruptions, reductions, and dose intensity) (time frame: assessed up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05238883, which also lists 1 linked publication.

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 21 Nov 2025.

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