Payload Information

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Each Antibody-drug Conjugate Related to This Payload

Full Information of The Activity Data of The ADC(s) Related to This Payload

BAY-1862864 [Phase 1]

ADC Info

Identified from the Human Clinical Data

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Experiment 1 Reporting the Activity Date of This ADC				[1]
Patients Enrolled	Key inclusion criteria: histologically confirmed relapsed/refractory CD22+ NHL with available tissue for CD22 testing; bone marrow involvement <25%; ≥1 prior failed chemo/immunotherapy; ineligible for HDT ASCR; ECOG ≤2; life expectancy ≥12 weeks; adequate organ function; reproductive safety measures; written informed consent
Administration Dosage	Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 1.5 MBq (2 mg antibody chelator conjugate [ACC]).
*Related Clinical Trial*
NCT Number	NCT02581878	Phase Status	PHASE1
Clinical Description	An Open-label Phase I, Dose-escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Biodistribution, Radiation Dosimetry and Pharmacokinetics of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma
Primary Endpoint	Primary endpoint is maximum tolerated dose (MTD) assessment based on dose-limiting toxicities (DLTs) occurrence [Time Frame: Up to 6 weeks].

References

Ref 1	Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma