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

  • STATUS
    Recruiting
  • End date
    Jul 24, 2027
  • participants needed
    213
  • sponsor
    Bayer
Updated on 5 December 2021

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. 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.

Details
Condition Cancers With HER2 Expression
Treatment BAY2701439, BAY2701438
Clinical Study IdentifierNCT04147819
SponsorBayer
Last Modified on5 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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
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
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/mm3
Platelet count 100,000/mm3
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 m2, 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

Exclusion Criteria

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
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