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Prostatic Neoplasms, Castration-ResistantPhase 1NCT02204072

BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)

A Phase 1 study testing BI 836845 and Enzalutamide in people with Prostatic Neoplasms, Castration-Resistant, run by Boehringer Ingelheim at 27 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The overall aim of the trial is to investigate the safety and anti-tumour activity of an experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide, compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients that have previously been treated and failed on… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
BI 836845 and Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
27 sitesin 8 countries
Study dates
11 Nov 2014to 1 Jun 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has histologically, or cytologically, confirmed adenocarcinoma of the prostate.
  • Male patient aged, equal to, or more than,18 years old.
  • Patients with radiographic evidence of metastatic prostate cancer (stage M1 or D2). Distant metastases evaluable by radionuclide bone scan, CT scan, or MRI within 28 days before the start of study treatment.
  • Patients with a prostate serum antigen (PSA), equal to, or more than, 5 nanograms per mililiter (ng/mL).
  • Patients with prior surgical or chemical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the patient must be willing to continue the use of LHRH agonists during protocol treatment.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
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  • Cardiac left ventricular function with resting ejection fraction >50% as determined by echocardiogram (ECHO) or multigated acquisition scan (MUGA).
  • Absolute neutrophil count (ANC) >=1500/microlitre (uL).
  • Haemoglobin >=9 gram per deciliter (g/dL).
  • Platelets >=100,000/uL.
  • Bilirubin <= 1.5 times the upper limit of normal (ULN).
  • Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 times the ULN(or <= 5 times the ULN if liver metastases are present).
  • Creatinine <= 1.5 x ULN.
  • International normalized ratio (INR) </= 2 and a partial thromboplastin time (PTT) </= 5 seconds above the ULN (unless on oral anticoagulant therapy). Patients receiving full dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (except warfarin or coumarin-like anticoagulants, which are not permitted).
  • Fasting plasma glucose < 8.9 millimols per liter (mmol/L) (< 160 milligrams per deciliter (mg/dL) and glycated haemoglobin (hemoglobin A1c (HbA1c)) < 8.0%.
  • Inclusion criteria only for patients entering phase Ib escalation and phase II:
  • Patients who have disease progression during, or after, receiving docetaxel and have had at least 12 weeks of treatment and in the opinion of the investigator are unlikely to derive significant benefit from additional docetaxel-based therapy, or were intolerant to therapy with this agent.
  • Patients who have disease progression during, or after, receiving abiraterone treatment in any setting.
  • Patients must have progressive disease defined as at least one of the following:
  • Progressive measurable disease: using conventional solid tumour criteria RECIST 1.1.
  • Bone scan progression: at least two new lesions on bone scan, plus a rising PSA as described in (c) below.
  • Increasing PSA level: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2.
  • Inclusion criterion only for patients entering phase Ib expansion cohort:
  • Patients must be receiving continuous enzalutamide treatment and show a rise in PSA level: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2.
  • Archive tumour tissue is available prior to recruitment for pharmacogenomic tests

Who cannot join

  • Prior therapy with agents targeting Insulin Growth Factor (IGF) and/or Insulin Growth Factor Receptor (IGFR) pathway.
  • Patients that have been treated with any of the following within 4 weeks of starting trial treatment: chemotherapy, immunotherapy, biological therapies, molecular targeted, hormone therapy (except LHRH agonists and LHRH antagonists), radiotherapy (except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within 2 weeks prior to study treatment).
  • Use of any investigational drug within 4 weeks before start of trial treatment or concomitantly with this trial.
  • Patients that have been treated with strong cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors, CYP2C8 inducers, within 2 weeks of starting the trial treatment.
  • Fridericia´s Corrected QT interval (QTcF) prolongation > 450 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome). The QTcF will be calculated as the mean of the 3 ECGs taken at screening.
  • Patients with small cell or neuroendocrine tumours.
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  • Patients with known or suspected leptomeningeal metastases.
  • Uncontrolled or poorly controlled hypertension.
  • Known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
  • Patients with epilepsy, seizures, or predisposing factors for seizure as judged by the investigator.
  • Patients unable to comply with the protocol as judged by the investigator.
  • Active alcohol or active drug abuse as judged by the investigator.
  • A history of allergy to human monoclonal antibodies.
  • Patients who are sexually active and unwilling to use a medically acceptable method of contraception, e.g. condom plus spermicide use for participating males, plus another form of birth control such as implants, injectables, combined oral contraceptives, intrauterine devices for female partners, during the trial and for at least three months after end of active therapy. Men unwilling to agree to not donate sperm while on trial drug and up to 6 months following the last dose of trial drug.
  • Previous or concomitant malignancies at any other site with the exception of the following:
  • benign basal cell carcinoma
  • benign low grade transitional cell carcinoma of the bladder
  • other effectively treated malignancy that has been in remission for more than 5 years and is considered to be cured
  • Only for patients entering phase Ib dose escalation and phase II cohorts:
  • Patients who have received more than 2 prior non-docetaxel containing cytotoxic chemotherapy regimens for Metastatic Castration-Resistant Prostate Cancer (mCRPC).
  • Patients who have received a taxane based treatment or abiraterone, within 4 weeks before start of study treatment.
  • Patients that have received prior enzalutamide in any setting will not be eligible.
  • Exclusion criterion only for patients entering phase Ib expansion cohort:
  • Patients that have received prior taxane-based chemotherapy or abiraterone in any setting will not be eligible for the expansion cohort.
  • Additional exclusion criterion for patients undergoing tumour biopsy:
  • For patients that are to undergo the tumour biopsy, a history of a hereditary bleeding disorder, or clinically relevant major bleeding event in the past 6 months, as judged by the investigator.
  • Further exclusion criteria apply

Trial locations and contacts

27 sites in 8 countries.

27 sites in 8 countries

Spain7 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08908

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Instituto Valenciano de Oncología

    Valencia, 46009

Other trials in Spain

United Kingdom5 sites

  • The Clatterbridge Cancer Centre

    Bebington, Wirral, CH63 4JY

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • The Christie Hospital

    Manchester, M20 4BX

  • Churchill Hospital

    Oxford, OX3 7LE

  • The Royal Marsden Hospital, Sutton

    Sutton, SM2 5PT

Other trials in United Kingdom

United States3 sites

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • NewYork-Presbyterian/Weill Cornell Medical Center

    New York, New York, 10065

  • Oregon Health and Sciences University

    Portland, Oregon, 97239

Other trials in United States

Singapore3 sites

  • National Cancer Centre Singapore

    Singapore, 169610

  • OncoCare Cancer Centre

    Singapore, 258499

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Taiwan3 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong, 999077

  • Queen Mary Hospital

    Hong Kong, 999077

Other trials in Hong Kong

Netherlands2 sites

  • Erasmus MC - Daniel den Hoed

    Rotterdam, 3075 EA

  • Tweesteden Ziekenhuis, locatie Tilburg

    Tilburg, 5042 AD

Other trials in Netherlands

South Korea2 sites

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Phase Ib/II, Multicentre, Open Label, Randomized Study of BI 836845 in Combination With Enzalutamide, Versus Enzalutamide Alone, in Metastatic Castration-Resistant Prostate Cancer (CRPC) Following Disease Progression on Docetaxel-Based Chemotherapy and Abiraterone

The overall aim of the trial is to investigate the safety and anti-tumour activity of an experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide, compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients that have previously been treated and failed on docetaxel and abiraterone treatments. Initially, a tolerability and safety phase (phase Ib escalation) will be performed to confirm the maximum tolerated dose (MTD), or recommended doses of both BI 836845 and enzalutamide that can be taken together.

Once the MTD, or recommended phase II dose, have been determined an expansion cohort will also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and have a rise in prostate serum antigen (PSA) levels. Patients may not have received prior docetaxel or abiraterone. Patients in this cohort will receive the MTD, or recommended phase II dose, of BI 836845 and enzalutamide determined in the phase Ib escalation phase.

Read more

The randomised trial (phase II) will be an open label, parallel group study design in a 1:1 ratio to which patients will receive either BI 836845 plus enzalutamide (Arm A) at the MTD/recommended doses, or enzalutamide alone (Arm B).

In all parts of the trial safety, anti-tumour activity will be assessed, in addition to circulating tumour cells (CTC), prostate serum antigen (PSA) response and progression, and determination of Overall Survival (OS).

Being tested
BI 836845, Enzalutamide
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

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

Study groups in NCT02204072
Study groupRoleWhat they receive
BI 836845 & EnzalutamideExperimentalNot described
Receives: Drug: BI 836845; Drug: Enzalutamide
EnzalutamideActive comparatorNot described
Receives: Drug: Enzalutamide

What is being measured

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

  1. Phase Ib Escalation Part: Number of Patients With Dose Limiting Toxicities (DLTs)

    Number of patients with DLTs were used to determine the maximum tolerated dose (MTD) in the Phase Ib escalation part. The MTD in this study was defined as the highest protocol dose level of xentuzumab in combination with enzalutamide, at which no more than 1 out of 6 patients in a cohort experienced a DLT during the MTD evaluation period.

    Measured: From first administration of xentuzumab up to start of Cycle 2, up to 28 days.

  2. Phase Ib Escalation Part: Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose Limiting Toxicity (DLT) During the First Treatment Course

    Maximum tolerated dose (MTD) based on the occurrence of dose limiting toxicity (DLT) during the first treatment course. The MTD in this study was defined as the highest protocol dose level of xentuzumab in combination with enzalutamide, at which no more than 1 out of 6 patients in a cohort experienced a DLT during the MTD evaluation period.

    Measured: From first administration of xentuzumab up to start of Cycle 2, up to 28 days.

  3. Phase Ib Expansion Part: Prostate Specific Antigen (PSA) Response

    The primary endpoint of the Phase Ib expansion part was PSA response. PSA response was defined as a decline in PSA value >50% compared to baseline which was confirmed by the next available value occurring at least 3 weeks later. The confirmatory value had to be at least 50% lower than the baseline, but could be higher than the first PSA value taken into account for response. However the confirmatory value was not allowed to be 50% higher than this first PSA value. If it was ≥ 50% higher than the first PSA value, the next available sample was to be taken to determine if response had been achieved. The date of response was the date that the first 50% (or greater) decline was observed. Number of participants with response is reported.

    Measured: At Cycle 1 Day 1 before study treatment and from Cycle 3 Day 1 and Day 1 of every cycle thereafter until the end of treatment, up to 35 months.

  4. Phase II Part: Progression Free Survival (PFS) Based on Investigator Assessment

    PFS was defined as the time from randomisation until radiological tumour progression in bone (based on Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria) or soft tissue (based on modified RECIST 1.1) or death from any cause, whichever occurred earlier. Clinical disease progression was not considered for determination of a PFS event, unless the outcome of the progression was death. Median PFS time in months is reported.

    PFS was calculated as follows:

    For patients with 'event' as an outcome for PFS (according to modified RECIST version 1.1 or PCWG2):

    PFS [days] = date of outcome - date of randomisation + 1.

    For patients with 'censored' as an outcome for PFS (according to modified RECIST version 1.1 or PCWG2):

    PFS (censored) [days] = date of outcome - date of randomisation + 1.

    Measured: From randomisation until radiological tumor progression or death from any cause, whichever occurred earlier, up to 1269 days.

Secondary outcomes (11)

  1. Phase Ib Expansion Part: Progression Free Survival (PFS) Based on Investigator Assessment

    PFS was defined as the time from randomisation until radiological tumour progression in bone (based on Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria) or soft tissue (based on modified RECIST 1.1) or death from any cause, whichever occurred earlier. Clinical disease progression was not considered for determination of a PFS event, unless the outcome of the progression was death. Median PFS time in months is reported.

    PFS was calculated as follows:

    For patients with 'event' as an outcome for PFS: (according to modified RECIST version 1.1 or PCWG2) PFS [days] = date of outcome - date of first treatment administration + 1.

    For patients with 'censored' as an outcome for PFS (according to modified RECIST version 1.1 or PCWG2):

    PFS (censored) [days] = date of outcome - date of first treatment administration + 1.

    Measured: From first treatment administration of any study medication until radiological tumor progression or death from any cause, whichever occurred earlier, up to 1114 days.

  2. Phase Ib Expansion Part: Changes in Circulating Tumour Cells (CTC) Response - CTC Reduction From >=5 to <5 Cells Per 7.5 mL Blood for at Least One Post-baseline Time Point

    Changes in circulating tumour cells (CTC) response - CTC reduction from >=5 to <5 cells per 7.5 mL blood for at least one post-baseline time point. Number of participants with CTC Response (yes/no) is reported.

    Measured: Prior to study drug administration at Day 1 Cycle 1, Day 1 Cycle 2, Day 1 Cycle 3, Day 1 Cycle 5, Day 1 Cycle 7 and every 12 weeks thereafter, up to end of treatment. Up to 35 months.

  3. Phase II Part: Radiological Progression Free Survival (PFS), Based on Central Review

    PFS was defined as the time from randomisation until radiological tumour progression in bone (based on Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria) or soft tissue (based on modified RECIST 1.1) or death from any cause, whichever occurred earlier. Clinical disease progression was not considered for determination of a PFS event, unless the outcome of the progression was death. Median PFS time in months is reported.

    PFS was calculated as follows:

    For patients with 'event' as an outcome for PFS: (according to modified RECIST version 1.1 or PCWG2) PFS [days] = date of outcome - date of first treatment administration + 1.

    For patients with 'censored' as an outcome for PFS (according to modified RECIST version 1.1 or PCWG2):

    PFS (censored) [days] = date of outcome - date of first treatment administration + 1.

    Measured: From randomisation until radiological tumor progression or death from any cause, whichever occurred earlier, up to 1269 days.

  4. Phase II Part: Overall Survival (OS)

    Overall survival (OS) defined as the time from randomisation to death from any cause. Median survival time in months is reported.

    Overall survival at cut-off date for final analysis (24-Oct-2019) is reported.

    Measured: From randomisation until radiological tumor progression or death from any cause (until cut-off date for final analysis), whichever occurred earlier, up to 1269 days.

  5. Phase II Part: Time to Prostate Specific Antigen (PSA) Progression

    For the definition of time to PSA progression, the following rules are used:

    • Decline from baseline in PSA before increasing: Time to PSA progression is defined as the time from the date of randomisation until the date where a 25% or greater increase in PSA and an absolute increase of 2 ng/mL or more from baseline, is documented (which is confirmed by the next available value occurring at least 3 weeks later).
    • No decline from baseline in PSA: Time to PSA progression is defined as the time from the date of randomisation until the date where a 25% or greater increase in PSA and an absolute increase of 2 ng/mL or more from baseline, is documented. However, only values after 12 weeks of therapy are considered.

    Time to PSA progression [days] = date of PSA progression - date of randomisation + 1.

    For patients not presenting with PSA progression or being lost to follow-up:

    Time to PSA progression (censored) [days] = date of censoring - date of randomisation + 1.

    Measured: At screening, at Cycle 1 Day 1 and from Cycle 3 Day 1 and at Day 1 of every cycle thereafter until end of treatment, up to 40.1 months.

  6. Phase II Part: Maximum Decline in Prostate Specific Antigen (PSA)

    Maximum decline in (PSA) compared to baseline. The maximum decline in PSA is defined as the change in PSA between the baseline PSA value and the minimum post-baseline PSA value. The change from baseline is defined as: Change from baseline in PSA (ng/mL) = PSA value post-baseline - PSA value at baseline.

    Maximum decline in PSA is defined as:

    Maximum decline in PSA (ng/mL) = min(PSA value post-baseline) - PSA value at baseline.

    Measured: At screening, at Cycle 1 Day 1 and from Cycle 3 Day 1 and at Day 1 of every cycle thereafter until end of treatment, up to 40.1 months.

  7. Phase II Part: Percentage Change in Prostate Specific Antigen (PSA) at Week 12

    Percentage change in PSA from baseline to Week 12. Percentage change in PSA from baseline to week 12 of treatment is defined as:

    Percentage change in PSA (%) = 100*(PSA value at week 12 - PSA value at baseline)/PSA value at baseline

    For this assessment, it is allowed to take a value:

    • until one week later than week 12, in case the PSA assessment was delayed
    • one day earlier due to the one day window allowed by the protocol Values from assessments between day 84 and day 92 after first treatment administration will therefore be taken into account (according to the protocol schedule for visits at week 12).

    Measured: At baseline and at Week 12.

  8. Phase II Part: Prostate Specific Antigen (PSA) Response

    PSA response - defined as a decline in PSA value >50% (which is confirmed by a second value 3 to 4 weeks apart).

    PSA response was defined as a decline in PSA value >50% compared to baseline which was confirmed by the next available value occurring at least 3 weeks later. The confirmatory value had to be at least 50% lower than the baseline, but could be higher than the first PSA value taken into account for response. However the confirmatory value was not allowed to be 50% higher than this first PSA value. If it was ≥ 50% higher than the first PSA value, the next available sample was to be taken to determine if response had been achieved. Number of participants with response is reported.

    Measured: At Cycle 1 Day 1 and from Cycle 3 Day 1 and at Day 1 of every cycle thereafter until end of treatment, up to 40.1 months.

  9. Phase II Part: Circulating Tumour Cells (CTC) Reduction Defined as CTC Decline From ≥5 to <5 Cells Per 7.5 mL Blood for at Least One Post-baseline Time-point

    CTC reduction is defined as CTC decline from ≥5 to <5 cells per 7.5 mL blood for at least one post-baseline time-point. Patients with a CTC value < 5 cells per 7.5mL blood at baseline, or with missing baseline values were not taken into consideration for this endpoint. Baseline value is the value collected before a patient starts treatment with trial medication.

    Number of participants per category is reported.

    Measured: Prior to study drug administration at Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1 and then every 12 weeks thereafter, until end of treatment. Up to 40.1 months.

  10. Phase II Part: Maximum Decline (%) in Circulating Tumour Cells (CTC) Counts

    Maximum decline in CTC counts (in number of cells) compared with baseline that occurred at any point after treatment start , defined as the difference between the minimum post-baseline CTC value and the baseline CTC value. Patients with missing baseline value are considered missing for this criterion. Baseline value is the value collected before a patient starts treatment with trial medication. Positive values for maximum decline in CTC are possible in case no decline in CTC occurred. This indicates an increase in CTC.

    Measured: Prior to study drug administration at Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1 and then every 12 weeks thereafter, until end of treatment. Up to 40.1 months.

  11. Phase II Part: Circulating Tumour Cells (CTC) Status at Week 12

    CTC status (≥5 or <5 cells per 7.5mL blood) at Week 12. Number of participants per category is reported.

    Measured: At Week 12.

Timeline

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

  1. First posted30 Jul 2014 (estimated)
  2. Study start11 Nov 2014
  3. Primary completion18 Oct 2019
  4. Study completion1 Jun 2023

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02204072
Sponsor's protocol ID
1280.8
Other IDs
2013-004011-41
Status last verified
Jun 2025
First submitted
29 Jul 2014
Last updated
15 Jul 2025
Individual data sharing
Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 836845 and Enzalutamide in people with Prostatic Neoplasms, Castration-Resistant, run by Boehringer Ingelheim at 27 sites in 8 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 25 inclusion and 27 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: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Spain, United Kingdom, United States, Singapore, Taiwan and 3 more countries. 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?

Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase Ib Escalation Part: Number of Patients With Dose Limiting Toxicities (DLTs) (time frame: From first administration of xentuzumab up to start of Cycle 2, up to 28 days.). The study lists 4 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 NCT02204072.

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 15 Jul 2025.

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