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Advanced Solid Tumor Historically Known for High EphA2 ExpressionPhase 1/2NCT04180371

Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

A Phase 1/2 study testing BT5528 and Nivolumab in people with Advanced Solid Tumor Historically Known for High EphA2 Expression and Urothelial Cancer, run by BicycleTx Limited at 28 sites in 5 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BT5528 and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
28 sitesin 5 countries
Study dates
7 Nov 2019to 31 Jul 2027
Phase
Phase 1/2
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

None listed.

Who cannot join

  • Chemotherapy treatments within 14 days prior to first dose of study treatment, other anticancer treatments, treatment within 28 days or 5 half-lives, whichever is the shorter
  • Experimental treatments within 4 weeks of first dose of BT5528
  • Prior toxicities must have resolved to Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 (except alopecia which can be Grade 2), or well-controlled Grade 2 hypothyroidism or Grade 2 adrenal insufficiency on appropriate therapy
  • Current treatment with strong inhibitors or inducers of CYP3A4 or strong inhibitors of P-gp
  • Known sensitivity to any of the ingredients of the investigational product or monomethyl auristatin E (MMAE)
  • Any condition, therapy or laboratory abnormality that might confound the results of the study, interfere with the patient's participation, or is not in the best interest of the patient to participate in the opinion of the investigator including but not limited to specific cardiovascular criteria
Show all 33Show fewer
  • Major surgery (excluding placement of vascular access) within 4 weeks of first dose of BT5528 study treatment and must have recovered adequately prior to starting study therapy
  • Receipt of live vaccine within 30 days of study treatment
  • Untreated CNS metastases or leptomeningeal disease
  • Uncontrolled hypertension (systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg that is not responsive to intervention) at screening or prior to initiation of study drug.
  • History or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the study, interfere with the patient's participation, or is not in the best interest of the patient to participate in the opinion of the Investigator including but not limited to:
  • Patients with history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, congestive heart failure or symptoms of New York Heart Association Class III-IV documented within 6 months prior to first dose of BT5528 or: (i) Mean resting corrected QT interval (QTcF) >470 msec (ii) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval (iii) Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third degree heart block
  • Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). Note: Well controlled HIV will be allowed if the patient meets all the following criteria at inclusion:
  • CD4+ T-cell (CD4+) counts ≥350 cells/uL;
  • HIV viral load <400 copies/mL
  • Without a history of opportunistic infection within the last 12 months.
  • On established antiretroviral therapy (ART) for at least 4 weeks. Use of anti-retroviral therapy is permitted, but should be discussed with the Medical Monitor on a case-by-case basis.
  • Patients with a positive hepatitis B surface antigen and/or anti-hepatitis B core antibody. Patients with a negative polymerase chain reaction (PCR) assay are permitted with appropriate antiviral therapy
  • Active hepatitis C infection with positive viral load if hepatitis C virus (HCV) antibody positive (if antibody is negative then viral load not applicable). Patients who have been treated for hepatitis C infection can be included if they have documented sustained virologic response of ≥12 weeks.
  • Thromboembolic events and/or bleeding disorders 3 months (e.g., deep vein thrombosis [DVT] or pulmonary embolism [PE]) prior to first dose
  • Prior history of pneumonitis with presence of residual symptoms
  • History of another malignancy within 3 years before the first dose of BT5528, or any evidence of residual disease from a previously diagnosed malignancy (excluding adequately treated with curative intent basal cell carcinoma, squamous cell of the skin, cervical intraepithelial neoplasia/cervical carcinoma in situ or melanoma in situ or ductal carcinoma in situ of the breast).
  • Systemic anti-infective treatment or fever within the last 14 days prior to first dose of BT5528 study treatment
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
  • Additional Exclusion Criteria (BT5528 in combination with nivolumab):
  • Prior intolerance to immune checkpoint inhibitor
  • Known hypersensitivity to checkpoint inhibitor therapy
  • Prior organ transplant (including allogeneic)
  • Diagnosis of clinically relevant immunodeficiency
  • Active systemic infection requiring therapy
  • More than 10 mg daily prednisone equivalent or other strong immunosuppressant
  • History of autoimmune disease except alopecia, vitiligo, hypothyroidism, or adrenal insufficiency
  • History of interstitial lung disease

Trial locations and contacts

28 sites in 5 countries.

28 sites in 5 countries

United States12 sites

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • California Cancer Associates for Research and Excellence, Inc.

    Encinitas, California, 92024

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Sarah Cannon and HCA Research Institute

    Nashville, Tennessee, 37221

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Stephenson Cancer Center (Oklahoma University)

    Oklahoma City, Oklahoma, 73104

  • University of California - Irvine Medical Center

    Orange, California, 92868

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

Other trials in United States

Spain5 sites

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, 08908

  • Hospital Universitario Vall d'Hebron

    Barcelona, 8035

  • Hospital Fundación Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

Other trials in Spain

United Kingdom5 sites

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • The Leeds Teaching Hospitals NHS Trust Of Trust Headquarters, St James's University Hospital

    Leeds, LS9 7TF

  • Sarah Cannon Research Institute UK

    London, United Kingdom, W1G 6AD

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom, M20 4BX

  • Sir Bobby Robson Cancer Trials Research Centre, The Northern Center for Cancer Care, Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Belgium4 sites

  • Institut Jules Bordet

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels

  • Antwerp University Hospital (UZA)

    Edegem

  • Universitair Ziekenhuis Gent (UZ)

    Ghent, 9000

Other trials in Belgium

South Korea2 sites

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722

Other trials in South Korea

About this study

Official title: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression

This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to:

  • Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab
  • Learn more about the side effects of BT5528
  • Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer.
  • Learn more about BT5528 therapy alone and in combination with nivolumab.
Read the detailed description

BT5528 consists of a bicyclic peptide (Bicycle®) which binds to EphA2, and is covalently attached to a spacer and a protease cleavable peptide linker attached to MMAE.

The Phase I/II multi-center, open-label trial will evaluate BT5528 administered once-weekly as a single agent and in combination with nivolumab. The Phase I portion is a dose escalation primarily designed to assess the safety and tolerability of BT5528 and to determine recommended Phase II dose(s) (RP2D). Following selection of a recommended Phase II dose(s) (RP2D), a dose expansion portion will be initiated with the primary objective of evaluating the clinical activity of BT5528.

Being tested
BT5528, Nivolumab
Keywords
EphA2, ovarian cancer, urothelial cancer, bladder cancer, NSCLC, TNBC, gastric cancer, GEJ cancer, HNSCC
Medical subject headings
Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Triple Negative Breast Neoplasms, Gastrointestinal Neoplasms, Urinary Bladder Neoplasms, Stomach Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • BT5528Drug

    Participants will receive a 60-minute intravenous infusion of BT5528 once a week (Days 1, 8, 15, and 22) or every other week (Days 1 and 15) on a 4-week cycle at the selected dose.

  • NivolumabDrug

    Also called Opdivo

    Participants will receive nivolumab at 480mg intravenous infusion every 4 weeks.

Study groups in NCT04180371
Study groupRoleWhat they receive
Phase I - Dose escalation (BT5528)ExperimentalCohorts of participants will receive increasing doses of BT5528. It is expected that up to 72 participants will participate in this dose escalation arm.
Receives: Drug: BT5528
Phase I - Dose escalation combination (BT5528 & nivolumab)ExperimentalCohorts of participants will receive increasing doses of BT5528 and a standard dose of nivolumab. It is expected that up to 24 participants will participate in this dose-escalation combination arm.
Receives: Drug: BT5528; Drug: Nivolumab
Phase II - Dose expansion 1 (BT5528)ExperimentalA cohort of participants will receive the selected dose of BT5528 as a monotherapy. It is expected that up to 164 patients have solid tumors (Cohort 1: urothelial cancers, Cohort 2: ovarian cancer, Cohort 3: non-small cell lung cancer, Cohort 4: head and neck cancer, Cohort 5: triple-negative breast cancer, and Cohort 6: gastric/upper gastrointestinal cancer) historically known for high expression of EphA2 will participate in this dose-expansion arm, Cohort 7: urothelial MMAE exposed, Cohort 8: head and neck squamous cell carcinoma
Receives: Drug: BT5528

What is being measured

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

  1. Part A-1 and A-2(escalations): Number of participants receiving BT5528 alone and in combination with nivolumab with treatment-emergent adverse events

    Safety reported as incidence of treatment-emergent adverse events

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until 30 days post last dose

  2. Part A-1 and A-2 (escalations): Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities from BT5528 treatment alone and in combination with nivolumab

    Maximum Tolerated Dose (MTD)

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  3. Part B: Objective response rate by RECIST 1.1 in participants with solid tumors historically known for high expression of EphA2 tumor expression receiving BT5528 treatment

    Objective Response Rate (ORR)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks during study treatment)

  4. Part B: Duration of response by RECIST 1.1 in participants with solid tumors historically known for high expression of EphA2 receiving BT5528 treatment

    Duration of Response (DOR)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks during study treatment)

  5. Part B: Clinical benefit rate by RECIST 1.1 in participants with solid tumors historically known for high expression of EphA2 receiving BT5528 treatment

    Clinical benefit rate

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks during study treatment)

  6. Part B: Time to tumor progression by RECIST 1.1 in participants solid tumors historically known for high expression of EphA2 receiving BT5528 treatment

    Time to Progression (TTP)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks during study treatment)

  7. Part B: Progression-free survival by RECIST 1.1 in participants solid tumors historically known for high expression of EphA2 receiving BT5528 treatment

    Progression free survival (PFS)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks during study treatment)

  8. Part B: PFS at 6 months by RECIST 1.1 in participants with solid tumors historically known for high expression of EphA2 receiving BT5528 treatment

    Progression free survival (PFS)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months)

  9. Part B: Overall survival (OS) at 1 year in participants solid tumors historically known for high expression of EphA2 receiving BT5528 treatment

    Overall survival (OS)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until death or loss of follow-up or withdrawal of consent

Secondary outcomes (17)

  1. Part A-1 and A-2 (escalations): Objective response rate (ORR) by RECIST 1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 alone and in combination with nivolumab

    Objective Response Rate (ORR)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months

  2. Part A-1 and A-2 (escalations): Duration of response (DOR) by RECIST 1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 alone and in combination with nivolumab

    Duration of Response (DOR)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months

  3. Part A-1 and A-2 (escalations): Clinical benefit rate (CBR) by RECIST 1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 alone and in combination with nivolumab

    Clinical benefit rate (CBR)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months

  4. Part A-1 and A-2 (escalations): Time to tumor progression (TTP) by RECIST 1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 alone and in combination with nivolumab

    Time to progression (TTP)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months

  5. Part A-1 and A-2 (escalations): Progression-free survival (PFS) time by RECIST 1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 alone and in combination with nivolumab

    Progression free survival (PFS)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months

  6. Part A-1 and A-2 (escalations): Progression free survival at 6 months by RECIST 1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 alone and in combination with nivolumab

    Progression free survival (PFS)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months)

  7. Part A-1 and A-2 (escalations): Overall survival time at 12 months in participants with advanced solid tumors with high EphA2 levels receiving BT5528 alone and in combination with nivolumab

    Overall survival (OS)

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until death or loss of follow-up or withdrawal of consent (assessed every 3 months up to 12 months

  8. Part B: Determination of the number of participants with advanced solid tumors historically known for high expression of EphA2 receiving BT5528 with treatment-emergent adverse events

    Safety reported as incidence of treatment-emergent adverse events

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until 30 days post last dose

  9. All parts: Determine the plasma concentrations of BT5528 in plasma from all participants taking BT5528 alone and in combination with nivolumab

    plasma concentrations of BT5528 in plasma from all participants taking BT5528 alone and in combination with nivolumab

    Measured: From Cycle 1,and end of each cycle (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or withdrawal of consent(assessed up to 12 months

  10. All parts: Determine the plasma concentrations of MMAE in plasma from all participants taking BT5528 alone and in combination with nivolumab

    plasma concentrations of MMAE in plasma from all participants taking BT5528 alone and in combination with nivolumab

    Measured: From Cycle 1,and end of each cycle (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or withdrawal of consent(assessed up to 12 months

  11. All parts: Number of participants positive for anti-drug antibodies (ADA) from all participants receiving BT5528 alone and in combination with nivolumab

    Measured: From Cycle 1,and end of each cycle (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or withdrawal of consent(assessed up to 12 months

  12. Part B: The association between EphA2 expression level and objective response rate (ORR) per RECIST v1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    To investigate if the high expression of EphA2 is associated with high ORR per RECIST 1.1 participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months

  13. Part B: The association between EphA2 expression level and duration of response (DOR) by RECIST 1.1 and per EphA2 expression in participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    To investigate if the high expression of EphA2 is associated with high DOR per RECIST 1.1 participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months

  14. Part B: The association between EphA2 expression level and clinical benefit rate (CBR) per RECIST v1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    To investigate if the high expression of EphA2 is associated with high CBR per RECIST 1.1 participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months

  15. Part B: The association between EphA2 expression level and time to tumor progression (TTP) per RECIST v1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    To investigate if the high expression of EphA2 is associated with long TTP per RECIST 1.1 participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months

  16. Part B: The association between EphA2 expression level and progression-free survival (PFS) at 6 months by RECIST 1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    To investigate if the high expression of EphA2 is associated with long PFS at 6 months per RECIST 1.1 participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months

  17. Part B: The association between EphA2 expression level and overall survival (OS) at 1 year by RECIST v1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    To investigate if the high expression of EphA2 is associated with long OS at 1 year per RECIST 1.1 participants with advanced solid tumors with high EphA2 levels receiving BT5528 treatment

    Measured: From Cycle 1 Day 1 (each cycle is 28 days) until death or loss of follow-up or withdrawal of consent (assessed every 3 months up to 12 months)

Timeline

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

  1. First posted27 Nov 2019
  2. Study start7 Nov 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jul 2027 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
288 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04180371
Sponsor's protocol ID
BT5528-100
Status last verified
Oct 2026
First submitted
19 Nov 2019
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BT5528 and Nivolumab in people with Advanced Solid Tumor Historically Known for High EphA2 Expression and Urothelial Cancer, run by BicycleTx Limited at 28 sites in 5 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 0 inclusion and 33 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Spain, United Kingdom, Belgium, South Korea. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Part A-1 and A-2(escalations): Number of participants receiving BT5528 alone and in combination with nivolumab with treatment-emergent adverse events (time frame: From Cycle 1 Day 1 (each cycle is 28 days) until 30 days post last dose). The study lists 9 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 NCT04180371.

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 16 Oct 2026.

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