A First-in-Humans Dose Finding Study for an Aryl Hydrocarbon Receptor Inhibitor (AhRi) in Patients With Advanced Cancer

  • STATUS
    Recruiting
  • End date
    May 4, 2023
  • participants needed
    174
  • sponsor
    Bayer
Updated on 16 April 2021

Summary

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.

Details
Condition Advanced Solid Tumors
Treatment BAY2416964
Clinical Study IdentifierNCT04069026
SponsorBayer
Last Modified on16 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Advanced Solid Tumors?
Do you have any of these conditions: Do you have Advanced Solid Tumors??
Do you have any of these conditions: Do you have Advanced Solid Tumors??
Do you have any of these conditions: Do you have Advanced Solid Tumors??
Do you have any of these conditions: Do you have Advanced Solid Tumors??
Do you have any of these conditions: Do you have Advanced Solid Tumors??
Do you have any of these conditions: Do you have Advanced Solid Tumors??
Do you have any of these conditions: Do you have Advanced Solid Tumors??
Do you have any of these conditions: Do you have Advanced Solid Tumors??
Do you have any of these conditions: Do you have Advanced Solid Tumors??
Do you have any of these conditions: Do you have Advanced Solid Tumors??
Do you have any of these conditions: Do you have Advanced Solid Tumors??
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. Note: there is no limit to the number of prior treatment regimens. Immune checkpoint inhibitors are also allowed in pretreatment
Dose Escalation: all solid tumor types
Tumor type-specific high-dose (MTD or MAD) Expansion cohorts: Will be grouped by tumor type, but no specific biomarker selection will be applied
NSCLC
HNSCC
Colorectal cancer MSS
Tumor type-specific low-dose Expansion cohort: Any tumor type based on data from dose escalation and expansion indicating pharmacodynamics effect and/or clinical response from the tumor type-specific high-dose(MTD or MAD) expansion
Urothelial cancer
Have measurable disease per RECIST 1.1 as assessed by CT/MRI. At least one measurable 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 measurable if progression has been demonstrated in such lesions
Life expectancy at least 12 weeks
Eastern Cooperative Oncology Group (ECOG)performance status of 0 to 1
Adequate bone marrow and organ function as assessed by the following laboratory tests performed within 7 days before treatment initiation
Bone marrow reserve
Absolute neutrophil count (ANC) 1.5 x 109/L
Hemoglobin (Hb) 9.0g/dL, without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
Platelet count 100 x 109/L. Transfusion to meet the inclusion criteria will not be allowed
Hepatic
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)
Albumin > 25 g/L
Renal
\--- eGFR 60 mL/min as calculated using the MDRD equation or creatinine level
5x ULN
Lipase and amylase 1.5 x ULN
Coagulation
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)
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

Exclusion Criteria

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
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 known active central nervous system (CNS) metastases and/or carcinomatous meningitis
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 imaging (note that repeat imaging should be performed
Interstitial lung disease or chronic obstructive pulmonary disease (COPD) with ongoing signs and symptoms at the time of screening. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
during study screening), clinically stable and without requirement of steroid
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 etiology
treatment for at least 14 days prior to first dose of study intervention
History of organ allograft transplantation, including allogeneic bone marrow transplantation
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
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
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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