Cancers With HER2 ExpressionPhase 1NCT04147819
A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein
A Phase 1 study testing BAY2701439 in people with Cancers With HER2 Expression, run by Bayer at 6 sites in 2 countries.
Trial summary
In this study, researchers want to learn about the safety of drug BAY2701439 and how well the drug works in patients with advanced cancer that has the protein HER2 (Human Epidermal growth factor Receptor 2) and cannot be cured by currently available treatment options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancers With HER2 Expression
- What is being tested?
- BAY2701439
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 2 Jul 2020to 26 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female participants at least 18 years of age on the day of signing informed consent.
- Participants must meet the study phase-specific disease requirements:
- Dose escalation:
- Pathologically documented, HER2-expressing (IHC3+, 2+, or 1+ and/or ISH+), unresectable locally advanced or metastatic gastric, gastroesophageal, or breast cancer that has relapsed after standard treatment options, or for which no standard treatment is available. Participants with gastric or gastroesophageal cancer must not have had prior definitive radiotherapy. Participants in the dose escalation cohorts must have evaluable disease by RECIST 1.1, assessed by local imaging.
- Dose expansion: Group A: Pathologically documented unresectable, locally advanced or metastatic breast cancer with HER2 overexpression or amplification (IHC3+ or IHC2+/ISH+) that has relapsed that has relapsed after standard treatment options, or for which no standard treatment is available.
- Group B: Pathologically documented unresectable locally advanced or metastatic breast cancer with HER2 low expression (IHC2+/ISH-, IHC1+/ISH-, or IHC1+/ISH untested) that has relapsed after standard treatment options, or for which no standard treatment is available.
Show all 26Show fewer
- Group C: Pathologically documented, unresectable locally advanced or metastatic carcinomas other than breast cancer with HER2 overexpression or amplification/mutation (IHC3+ or IHC2+/ISH+), that has relapsed after standard treatment options or for which no standard treatment is available.
- Participants in the dose expansion cohorts must have measurable disease by RECIST 1.1, assessed by local imaging.
- Availability of fresh or archival tumor samples - archival tumor samples obtained after disease progression on the most recent anti-cancer treatment may be accepted; those obtained prior to the last anti-cancer treatment may be accepted, upon agreement between the Sponsor and the Investigator.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Life expectancy of at least 6 months, as estimated by the Investigator.
- Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements, to be conducted within 28 days before start of BAY2701439 administration:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1500/mm*3
- Platelet count ≥ 100,000/mm*3
- Total bilirubin ≤ 1.5 X the upper limit of normal (ULN), except if confirmed history of Gilbert's disease
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ˂ 2.5 x ULN (≤ 5 x ULN for participants with liver involvement)
- Participants on a stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting, and Prothrombin time/International normalized ratio (PT/INR) and aPTT test results are compatible with the acceptable benefit-risk ratio at the Investigator's discretion
- Serum creatinine ≤ 1.5 x ULN and glomerular filtration rate (GFR)≥ 45 mL/min/1.73 m*2, according to the Modified Diet in Renal Disease (MDRD)abbreviated formula.
- A negative serum pregnancy test in women of childbearing potential (WOCBP) performed within 7 days before the start of BAY2701439 administration. Women and men of reproductive potential must agree to use highly effective methods of contraception, when sexually active, during the time period between signing the informed consent form until at least 6 months after the last administration of BAY2701439.
- Male and/or female who meet the requirements for contraception and breastfeeding as follows:
- Male participants: A male participant must agree to use highly effective contraception during the intervention period and for at least 6 months after intervention and refrain from donating sperm during this period.
- Female participants: A female participant is eligible to participate if she is not pregnant (confirmed by a negative serum pregnancy test within 7 days of first study treatment), not breastfeeding, or is not a woman of childbearing potential.
- Women of childbearing potential (WOCBP) must agree to use highly effective contraception during the intervention period and for at least 6 months after the last dose of study treatment.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Who cannot join
- Impaired cardiac function or clinically significant cardiac disease (i.e. congestive heart failure (CHF) New York Heart Association (NYHA) Class II, III or IV).
- Left ventricular ejection fraction (LVEF) < 50% (as measured at screening by echocardiogram).
- History or concurrent condition of interstitial lung disease/pneumonitis or severely impaired pulmonary function.
- Participants known to be affected by genetic defects linked to radiation hypersensitivity, such as ataxia-telangiectasia (A-T; Online Mendelian Inheritance in Man [OMIM] #208900) and A-T-like disorder (meiotic recombination 11 homolog [MRE11]), Nijmegen breakage syndrome (OMIM #251260) and Nijmegen breakage Syndrome-like disorder (RAD50), Fanconi anemia (OMIM #227650), DNA ligase IV deficiency (OMIM #606593), RIDDLE syndrome (RNF168), radiosensitive severe combined immunodeficiency (RS-SCID), DNA-PK radiosensitive combined immunodeficiency (DNA-PK-RS-SCID), Cornelia de Lange syndrome.
- History of Myelodysplastic syndrome (MDS)/treatment-related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML.
- Infections of Common terminology criteria for adverse events (CTCAE) version 5.0 Grade 2 not responding to therapy or active clinically serious infections of CTCAE Grade >2.
- History of hypersensitivity or severe infusion related reaction to any Trastuzumab-containing drug (e.g. trastuzumab, T-DM1) or any other ingredients contained in BAY2701439.
- Chemotherapy, experimental cancer therapy, biologic therapy or immunotherapy within 4 weeks before start of BAY2701439 administration. Start of study treatment is allowed in shorter timeframes provided 5 half-lives of the prior drug(s) have elapsed before the start of BAY2701439 administration. Previous high-dose chemotherapy needing hematopoietic-stem-cell-rescue is prohibited.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Johns Hopkins Hospital/Health System
Baltimore, Maryland, 21287
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center
New York, New York, 10022
Washington University School of Medicine
St Louis, Missouri, 63110
United Kingdom2 sites
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, SM2 5PT
About this study
Official title: A Phase 1 Open-label, First-in-human, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of Thorium-227 Labeled Antibody-chelator Conjugate BAY2701439, in Participants With Advanced HER2-expressing Tumors
In this study, researchers want to learn about the safety of drug BAY2701439 and how well the drug works in patients with advanced cancer that has the protein HER2 (Human Epidermal growth factor Receptor 2) and cannot be cured by currently available treatment options. The study will include patients with HER2 expressing breast, gastric (stomach) or gastroesophageal (stomach and esophagus) cancer, as well as other cancers that have HER2. Researchers want to find the best dose of BAY2701439 for patients and look at the way the body absorbs, distributes and excretes the drug.
The study drug is a type of therapy called a 'targeted alpha therapy' which uses an antibody to deliver a radioactive particle to cancer cells. BAY2701439 contains thorium-227 which emits radiation (a lot of energy that moves from one place to another with damaging effects). The thorium-227 in the drug is attached to an 'antibody' (large protein) that specifically binds to HER2 on the cancer cells and will emit its radiation in the form of alpha particles. The alpha particles are expected to damage the tumor cells and cause them to die, but spare surrounding tissue as alpha particles travel only very short distances in the body. This is the first study in humans for drug BAY2701439. Patients participating in this study will receive the drug by injection every 6 weeks a maximum 6 times. Observation after treatment last up to 3 years.
- Conditions
- Cancers With HER2 Expression
- Being tested
- BAY2701439
- Keywords
- Human epidermal growth factor receptor 2(HER2), Targeted alpha therapy, Thorium-227, HER2 low, HER2-low, HER2 positive, HER2-positive, HER2 expressing, HER2-expressing, Breast cancer, Gastric cancer
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2701439Drug
Intravenous (IV) injection on Day 1 of each cycle.The duration of each cycle will be 6 weeks (42 days).
BAY2701439Drug
Intravenous (IV) injection on Day 1 of each cycle and 1 hour before the start of administration of BAY2701439. The duration of each cycle will be 6 weeks (42 days).
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation of BAY2701439 | Experimental | The target population consists of participants with advanced HER2-expressing/amplified breast, gastric or gastroesophageal cancer. Receives: Drug: BAY2701439 |
| HER2 overexpressing breast cancer | Experimental | Dose expansion of BAY2701439 Receives: Drug: BAY2701439 |
| HER2 low expressing breast cancer | Experimental | Dose expansion of BAY2701439 Receives: Drug: BAY2701439 |
| Other HER2 overexpressing advanced carcinomas | Experimental | Dose expansion of BAY2701439 Receives: Drug: BAY2701439 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation: Incidence of TEAEs including TESAEs
TEAE: Treatment-emergent adverse event TESAE: Treatment-emergent serious adverse event
Measured: After first administration of study intervention up to 42 days after the last dose of study intervention
Dose escalation: Severity of TEAEs including TESAEs
Measured: After first administration of study intervention up to 42 days after the last dose of study intervention
Dose escalation: Frequency of DLTs at each dose level
DLT:Dose limiting toxicity
Measured: Up to 42 days after first administration of study intervention on cycle 1 (42 days) day 1
Dose expansion: ORR by RECIST 1.1 based on Investigator review
ORR: Objective response rate
Measured: Up to 12 months after End of treatment
Dose expansion: Frequency of TEAEs
Measured: After first administration of study intervention up to 42 days after the last dose of study intervention
Dose expansion: Severity of TEAEs
Measured: After first administration of study intervention up to 42 days after the last dose of study intervention
Secondary outcomes (9)
Dose escalation: Recommended dose level(s) of BAY2701439 for the dose expansion cohorts
The dose level(s) recommended for the dose expansion cohorts will be defined after evaluation of incidence and severity of TEAEs, PK, and ORR by RECIST 1.1, collected in the cycles of treatment during the dose escalation part of the study.
Measured: Maximum 6 cycles (each cycle is 42 days)
Dose escalation: Recommended treatment schedule of BAY2701439 for the dose expansion cohorts
The treatment schedule recommended for the dose expansion cohorts will be defined after evaluation of incidence and severity of TEAEs, PK, and ORR by RECIST 1.1, collected in the cycles of treatment during the dose escalation part of the study.
Measured: Maximum 6 cycles (each cycle is 42 days)
Dose expansion: Recommended dose for further clinical development of BAY2701439
The dose recommended for further clinical development will be defined after evaluation of incidence and severity of TEAEs, PK, and ORR by RECIST 1.1, collected in the cycles of treatment during the dose escalation and expansion parts of the study.
Measured: Maximum 6 cycles (each cycle is 42 days)
Cmax of thorium-227
Cmax: Maximum observed exposure
Measured: Cycle 1 (42 days)
Cmax of radium-223
Cmax: Maximum observed exposure
Measured: Cycle 1 (42 days)
Cmax of total antibody
Cmax: Maximum observed exposure
Measured: Cycle 1 (42 days)
AUC(0-42 days) of thorium-227
AUC: Area under the curve
Measured: Cycle 1 (42 days)
AUC(0-42 days) of radium-223
AUC: Area under the curve
Measured: Cycle 1 (42 days)
AUC(0-42 days) of total antibody
AUC: Area under the curve
Measured: Cycle 1 (42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start2 Jul 2020
- Primary completion21 Aug 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancers With HER2 ExpressionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147819
- Sponsor's protocol ID
- 19829
- Other IDs
- 2019-001741-40, 2019
- Status last verified
- Sep 2024
- First submitted
- 25 Oct 2019
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Anderson PM, Subbiah V, Trucco MM. Current and future targeted alpha particle therapies for osteosarcoma: Radium-223, actinium-225, and thorium-227. Front Med (Lausanne). 2022 Nov 15;9:1030094. doi: 10.3389/fmed.2022.1030094. eCollection 2022.
PubMed 36457575
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, First-in-human, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of Thorium-227 Labeled Antibody-chelator Conjugate BAY2701439, in Participants With Advanced HER2-expressing Tumors
- ClinicalTrials.gov ID
- NCT04147819
- Acronym / sponsor ID
- 19829
- Conditions
- Cancers With HER2 Expression
- Keywords
- Human epidermal growth factor receptor 2(HER2), Targeted alpha therapy, Thorium-227, HER2 low, HER2-low, HER2 positive, HER2-positive, HER2 expressing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 1 Nov 2019 (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.
In this study, researchers want to learn about the safety of drug BAY2701439 and how well the drug works in patients with advanced cancer that has the protein HER2 (Human Epidermal growth factor Receptor 2) and cannot be cured by currently available treatment options. The study will include patients with HER2 expressing breast, gastric (stomach) or gastroesophageal (stomach and esophagus) cancer, as well as other cancers that have HER2. Researchers want to find the best dose of BAY2701439 for patients and look at the way the body absorbs, distributes and excretes the drug.
The study drug is a type of therapy called a 'targeted alpha therapy' which uses an antibody to deliver a radioactive particle to cancer cells. BAY2701439 contains thorium-227 which emits radiation (a lot of energy that moves from one place to another with damaging effects). The thorium-227 in the drug is attached to an 'antibody' (large protein) that specifically binds to HER2 on the cancer cells and will emit its radiation in the form of alpha particles. The alpha particles are expected to damage the tumor cells and cause them to die, but spare surrounding tissue as alpha particles travel only very short distances in the body. This is the first study in humans for drug BAY2701439. Patients participating in this study will receive the drug by injection every 6 weeks a maximum 6 times. Observation after treatment last up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose escalation of BAY2701439 | Experimental | Drug: BAY2701439The target population consists of participants with advanced HER2-expressing/amplified breast, gastric or gastroesophageal cancer. |
| HER2 overexpressing breast cancer | Experimental | Drug: BAY2701439Dose expansion of BAY2701439 |
| HER2 low expressing breast cancer | Experimental | Drug: BAY2701439Dose expansion of BAY2701439 |
| Other HER2 overexpressing advanced carcinomas | Experimental | Drug: BAY2701439Dose expansion of BAY2701439 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Male or female participants at least 18 years of age on the day of signing informed consent.
- Participants must meet the study phase-specific disease requirements:
- Pathologically documented, HER2-expressing (IHC3+, 2+, or 1+ and/or ISH+), unresectable locally advanced or metastatic gastric, gastroesophageal, or breast cancer that has relapsed after standard treatment options, or for which no standard treatment is available. Participants with gastric or gastroesophageal cancer must not have had prior definitive radiotherapy. Participants in the dose escalation cohorts must have evaluable disease by RECIST 1.1, assessed by local imaging.
- Dose expansion: Group A: Pathologically documented unresectable, locally advanced or metastatic breast cancer with HER2 overexpression or amplification (IHC3+ or IHC2+/ISH+) that has relapsed that has relapsed after standard treatment options, or for which no standard treatment is available.
- Group B: Pathologically documented unresectable locally advanced or metastatic breast cancer with HER2 low expression (IHC2+/ISH-, IHC1+/ISH-, or IHC1+/ISH untested) that has relapsed after standard treatment options, or for which no standard treatment is available.
Key exclusion criteria (8 listed)
- Impaired cardiac function or clinically significant cardiac disease (i.e. congestive heart failure (CHF) New York Heart Association (NYHA) Class II, III or IV).
- Left ventricular ejection fraction (LVEF) < 50% (as measured at screening by echocardiogram).
- History or concurrent condition of interstitial lung disease/pneumonitis or severely impaired pulmonary function.
- Participants known to be affected by genetic defects linked to radiation hypersensitivity, such as ataxia-telangiectasia (A-T; Online Mendelian Inheritance in Man [OMIM] #208900) and A-T-like disorder (meiotic recombination 11 homolog [MRE11]), Nijmegen breakage syndrome (OMIM #251260) and Nijmegen breakage Syndrome-like disorder (RAD50), Fanconi anemia (OMIM #227650), DNA ligase IV deficiency (OMIM #606593), RIDDLE syndrome (RNF168), radiosensitive severe combined immunodeficiency (RS-SCID), DNA-PK radiosensitive combined immunodeficiency (DNA-PK-RS-SCID), Cornelia de Lange syndrome.
- History of Myelodysplastic syndrome (MDS)/treatment-related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML.
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 |
|---|---|---|
| BAY2701439Intravenous (IV) injection on Day 1 of each cycle.The duration of each cycle will be 6 weeks (42 days). | Drug | Dose escalation of BAY2701439, HER2 low expressing breast cancer, HER2 overexpressing breast cancer, Other HER2 overexpressing advanced carcinomas |
| BAY2701439Intravenous (IV) injection on Day 1 of each cycle and 1 hour before the start of administration of BAY2701439. The duration of each cycle will be 6 weeks (42 days). | Drug | Dose escalation of BAY2701439, HER2 low expressing breast cancer, HER2 overexpressing breast cancer, Other HER2 overexpressing advanced carcinomas |
Primary outcome
Dose escalation: Incidence of TEAEs including TESAEs
Time frame: After first administration of study intervention up to 42 days after the last dose of study intervention
TEAE: Treatment-emergent adverse event TESAE: Treatment-emergent serious adverse event
Dose escalation: Severity of TEAEs including TESAEs
Time frame: After first administration of study intervention up to 42 days after the last dose of study intervention
Dose escalation: Frequency of DLTs at each dose level
Time frame: Up to 42 days after first administration of study intervention on cycle 1 (42 days) day 1
DLT:Dose limiting toxicity
Dose expansion: ORR by RECIST 1.1 based on Investigator review
Time frame: Up to 12 months after End of treatment
ORR: Objective response rate
Dose expansion: Frequency of TEAEs
Time frame: After first administration of study intervention up to 42 days after the last dose of study intervention
Dose expansion: Severity of TEAEs
Time frame: After first administration of study intervention up to 42 days after the last dose of study intervention
9 secondary outcomes
Dose escalation: Recommended dose level(s) of BAY2701439 for the dose expansion cohorts
Time frame: Maximum 6 cycles (each cycle is 42 days)
Dose escalation: Recommended treatment schedule of BAY2701439 for the dose expansion cohorts
Time frame: Maximum 6 cycles (each cycle is 42 days)
Dose expansion: Recommended dose for further clinical development of BAY2701439
Time frame: Maximum 6 cycles (each cycle is 42 days)
Cmax of thorium-227
Time frame: Cycle 1 (42 days)
Cmax of radium-223
Time frame: Cycle 1 (42 days)
Cmax of total antibody
Time frame: Cycle 1 (42 days)
AUC(0-42 days) of thorium-227
Time frame: Cycle 1 (42 days)
AUC(0-42 days) of radium-223
Time frame: Cycle 1 (42 days)
AUC(0-42 days) of total antibody
Time frame: Cycle 1 (42 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 36457575Anderson PM, Subbiah V, Trucco MM. Current and future targeted alpha particle therapies for osteosarcoma: Radium-223, actinium-225, and thorium-227. Front Med (Lausanne). 2022 Nov 15;9:1030094. doi: 10.3389/fmed.2022.1030094. eCollection 2022.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Related trials for Cancers With HER2 Expression
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 1
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
RecruitingPhase 3
A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
HER2-positive Breast Cancer
RecruitingPhase 1
Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer
Lung Cancer (NSCLC), HER2 Expression
RecruitingPhase 3
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Endometrial Cancer
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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2701439 in people with Cancers With HER2 Expression, run by Bayer at 6 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 26 inclusion and 8 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 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose escalation: Incidence of TEAEs including TESAEs (time frame: After first administration of study intervention up to 42 days after the last dose of study intervention). The study lists 6 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 NCT04147819, 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 27 Sep 2024.