Dosage regimen of an anti-cdh6 antibody-drug conjugate

An anti-CDH6 antibody-drug conjugate for use in treating or preventing cancer, the anti-CDH6 antibody-drug conjugate having the structure represented by the following formula:

• wherein AB represents an anti-CDH6 antibody or the functional fragment of the antibody, n represents the average number of units of the drug-linker structure conjugated to the antibody per antibody, and the antibody is connected to the linker via a sulfhydryl group derived from the antibody;
• and wherein the anti-CDH6 antibody-drug conjugate is a salt thereof or a hydrate of the anti-CDH6 antibody-drug conjugate or the salt, wherein the average number of units of the drug-linker structure conjugated per antibody is 7 to 8, wherein the antibody comprises:
• the heavy chain amino acid sequence represented by SEQ ID NO:
• 87 or an amino acid sequence derived from the amino acid sequence represented by SEQ ID NO:
• 87 in which one or two amino acids are deleted from the carboxyl terminus thereof;
• and the light chain amino acid sequence represented by SEQ ID NO:
• 88, wherein a dose of the antibody-drug conjugate is in a range of 1.6 mg/kg to 9.6 mg/kg, wherein the antibody-drug conjugate is administered by intravenous administration, wherein the antibody-drug conjugate is administered once every 3 weeks.

A method of treating or preventing cancer in a subject, comprising administering to a subject with cancer an anti-CDH6 antibody-drug conjugate comprising an anti-CDH6 antibody and an antitumor compound connected by a linker, wherein the linker and the antitumor compound are represented by the following formula:

• -(Succinimid-3-yl-N)—CH2CH2CH2CH2CH2—C(═O)-GGFG-NH—CH2—O—CH2—C(═O)—(NH-DX)
• wherein -(Succinimid-3-yl-N)— has a structure represented by the following formula:
• which is connected to the antibody at position 3 thereof and is connected to a methylene group in the linker structure containing this structure on the nitrogen atom at position 1, and (NH-DX) represents a group represented by the following formula:
• wherein the nitrogen atom of the amino group at position 1 is the connecting position, wherein the anti-CDH6 antibody comprises CDRH1 consisting of the amino acid sequence of SEQ ID NO:
• 17, CDRH2 consisting of the amino acid sequence of SEQ ID NO:
• 60 and CDRH3 consisting of the amino acid sequence of SEQ ID NO:
• 19 in its heavy chain variable region and CDRL1 consisting of the amino acid sequence of SEQ ID NO:
• 12, CDRL2 consisting of the amino acid sequence of SEQ ID NO:
• 13 and CDRL3 consisting of the amino acid sequence of SEQ ID NO:
• 14 in its light chain variable region.

A method of treating or preventing cancer in a subject, comprising administering to a subject with cancer an anti-CDH6 antibody-drug conjugate having the structure represented by the following formula:

• wherein AB represents an anti-CDH6 antibody or the functional fragment of the antibody, n represents the average number of units of the drug-linker structure conjugated to the antibody per antibody, and the antibody is connected to the linker via a sulfhydryl group derived from the antibody;
• and wherein the anti-CDH6 antibody-drug conjugate is a salt thereof or a hydrate of the anti-CDH6 antibody-drug conjugate or the salt, wherein the average number of units of the drug-linker structure conjugated per antibody is 7 to 8, wherein the antibody comprises:
• the heavy chain amino acid sequence represented by SEQ ID NO:
• 87 or an amino acid sequence derived from the amino acid sequence represented by SEQ ID NO:
• 87 in which one or two amino acids are deleted from the carboxyl terminus thereof;
• and the light chain amino acid sequence represented by SEQ ID NO:
• 88, wherein a dose of the antibody-drug conjugate is in a range of 1.6 mg/kg to 9.6 mg/kg, wherein the antibody-drug conjugate is administered by intravenous administration, wherein the antibody-drug conjugate is administered once every 3 weeks.