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Association details:
Biomarker:HER-2 expression
Cancer:Lung Cancer
Drug:DF1001 (HER2 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Dose Escalation of DF1001 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications

Excerpt:
...HER2 expression by immunohistochemistry and/or erbb2 amplification and/or erbb2 activating mutations must be documented on either archival tissue or fresh tumor biopsy.Nivolumab Dose EscalationPatients must be eligible to receive nivolumab per its label for a malignancy of epithelial origin.ORPatients for which no standard therapy exists or standard therapy has failed. ...
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Phase 1/2 Study of DF1001, a novel tri-specific, NK cell engager therapy targeting HER2, in patients with advanced solid tumors: Phase 1 DF1001 monotherapy dose-escalation results.

Published date:
05/25/2023
Excerpt:
Best overall response (BoR) of Partial Response (PR) by RECIST 1.1 was observed in 5 patients, with duration of up to 13 months, and 22 patients experienced stable disease (SD), for a Clinical Benefit Rate (CBR) of 39.7%. Responders included patients with refractory lung and breast cancer, whose tumors expressed HER2 1+ to 3+ by IHC....DF1001 monotherapy demonstrates promising anti-tumor activity in treatment refractory patients with a spectrum of HER2 expression...
DOI:
10.1200/JCO.2023.41.16_suppl.2508
Trial ID: