An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of the Aryl Hydrocarbon Receptor Inhibitor (AhRi) BAY 2416964 in Participants With Advanced Solid Tumors

  • End date
    Jan 31, 2024
  • participants needed
  • sponsor
Updated on 20 October 2022


In this study researchers want to gather relevant information regarding the safety of BAY2416964 and how well the drug works in participants with a type of solid tumors that cannot be cured by currently available drugs. Researchers want to find the highest dose of BAY2416964 that participants could take without having too many side effects, how the drug is tolerated and the way the body absorbs, distributes and gets rid of the study dug. BAY2416964 is a small molecule which blocks the Aryl Hydrocarbon Receptor (a protein involved in immune cell reaction to tumor cells) allowing the body to use its immune response against the tumor cells.

Condition Advanced Solid Tumors
Treatment BAY2416964
Clinical Study IdentifierNCT04069026
Last Modified on20 October 2022


Yes No Not Sure

Inclusion Criteria

Participants must be ≥18 years of age inclusive, at the time of signing the informed consent
Participants with following histologically or cytologically confirmed advanced solid tumors that have progressed after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment
Dose Escalation: all solid tumor types
Tumor type-specific high-dose (MTD or MAD) Expansion cohorts: Will be grouped by tumor type
Life expectancy at least 12 weeks
Eastern Cooperative Oncology Group (ECOG)performance status of 0 to 1
Bone marrow reserve
Have measurable disease per RECIST 1.1 as assessed by CT/MRI. At least one measurable
Adequate bone marrow and organ function as assessed by the following laboratory tests performed within 7 days before treatment initiation
lesion by RECIST 1.1 is required. Lesions situated in a previously irradiated
area, or in an area subjected to other loco-regional therapy, are considered
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
measurable if progression has been demonstrated in such lesions
Platelet count ≥ 100 x 10^9/L. Transfusion to meet the inclusion criteria will not be allowed
Albumin > 25 g/L
Hemoglobin (Hb) ≥ 9.0g/dL, without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
Total bilirubin ≤ 1.5 x the upper limit of normal range (ULN). Known Gilbert syndrome is allowed if total bilirubin is ≤ 3 x ULN
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases)
\--- eGFR ≥ 60 mL/min as calculated using the MDRD equation or creatinine
level ≤ 1.5x ULN
Lipase and amylase ≤ 1.5 x ULN
International normalized ratio (INR) OR prothrombin time (PT) AND activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
Adequate cardiac function, measured by echocardiography within 28 days before start of
study intervention (left ventricular ejection fraction within institutional
normal range for age and gender)

Exclusion Criteria

Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
Congestive heart failure New York Heart Association (NYHA) greater than Class I or cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or calcium channel blockers
Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
Severe (CTCAE v.5 Grade ≥ 3) infections within 4 weeks before the first BAY2416964 administration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Clinically active infections (CTCAE v.5 > Grade 1) within 2 weeks before the first BAY2416964 administration
imaging (note that repeat imaging needs to be performed during study screening), clinically
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease
Participants with previously treated brain metastases may participate provided they are
radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat
stable and without requirement of steroid treatment for at least 14 days prior to first
dose of study intervention
Significant acute gastrointestinal disorders with diarrhea as a major symptom, e.g
Crohn's disease, malabsorption, or ≥ NCI-CTCAE v. 5.0 Grade 2 diarrhea of any
History of organ allograft transplantation, including allogeneic bone marrow
Has received prior radiotherapy within 2 weeks before start of BAY2416964 or received
radiation therapy to the lung that is > 30 Gy within 6 months before start of study
intervention. Participants must have recovered from all radiation-related toxicities
not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout
is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
Treatment with systemic immunosuppressant medications (including but not limited to
doses > 10 mg/day prednisone or equivalent, cyclophosphamide, azathioprine
methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2
weeks before the first BAY2416964 administration
The use of inhaled corticosteroids, or low doses of glucocorticoids (no more than 10 mg/day
prednisone or equivalent; if a higher dose would be needed to maintain adrenal function
investigator must obtain approval from sponsor), and mineralocorticoids (e.g
fludrocortisone for adrenal insufficiency) is allowed
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