A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults

Launched by BAYER · Aug 5, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant 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 clinically meaningful benefit, or are intolerant to treatment, or refuse standard treatment.
• • Dose Escalation: all solid tumor types
• * Tumor type-specific Expansion cohorts:
• • NSCLC
• • HNSCC with primary location in oropharynx, oral cavity, hypopharynx or larynx
• • Urothelial Cancer
• • Participants must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies.
• • Have measurable disease per RECIST 1.1
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Exclusion Criteria:
• • Severe (Common terminology criteria for adverse events (CTCAE) v.5 Grade ≥ 3) infections within 4 weeks before the first study intervention administration
• • Active autoimmune disease that has required systemic treatment in past 2 years
• • Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy
• • Has active Central nervous system (CNS) metastases and/or carcinomatous meningitis.
• • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• • Cardiac disease as specified in the protocol