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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors

Excerpt:
...- HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Safety and Tolerability of a Novel Anti-HER2 Antibody-Drug Conjugate (PF-06804103) in Patients With HER2-Expressing Solid Tumors: A Phase 1 Dose Escalation Study

Published date:
07/08/2023
Excerpt:
...in P2, patients with HER2+ or HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization [ISH]−) breast cancer received 3.0 or 4.0 mg/kg Q3W....Two (2/79, 2.5%) patients (P1, 4.0- and 5.0-mg/kg groups, n=1 each) achieved complete response; 21 (21/79, 26.6%) achieved partial response. In P2, ORR was higher in HER2+...PF-06804103 demonstrated antitumor activity...
DOI:
https://doi.org/10.1158/1535-7163.MCT-23-0101
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A phase I dose escalation study evaluating the safety and tolerability of a novel anti-HER2 antibody-drug conjugate (PF-06804103) in patients with HER2-positive solid tumors.

Excerpt:
In Part 1, groups of adult patients (pts) with HER2+ BC or HER2+ GC, who are resistant or intolerant to standard therapy or for which no standard therapy is available, received PF-06804103 intravenously once every 21 days (Q3W)...Preliminary ORR in the patients treated with doses ≥3mg/kg was 52.4% (11/21)....The PF-06804103 ADC demonstrated manageable toxicity and promising anti-tumor activity in this small, heavily pretreated study population.
DOI:
10.1200/JCO.2020.38.15_suppl.1039
Trial ID: