AnBogen Therapeutics Receives Approval from U.S. FDA for Phase Ib/II Protocol Amendment for ABT-101
U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) protocol amendment for its phase Ib/II trial of ABT-101, an orally administered, irreversible, mutant selective tyrosine kinase inhibitor targeting oncogenic mutations of HER2 Exon20 insertion expressed in non-small cell lung cancer (NSCLC).
The ABT101-102 clinical trial was approved by the Ministry of Health and Welfare and will be conducted at multiple medical centers.
The ABT101-102 clinical trial is divided into two phases, Phase I and Phase II, to evaluate the safety, tolerability, pharmacokinetics and antitumor efficacy of ABT101 in patients with HER2 Exon20 mutated non-small cell lung cancer (NSCLC) using the BOIN (Bayesian optimal interval design) method. NSCLC patients with HER2 Exon20 mutation, the safety, tolerability, pharmacokinetics and antitumor efficacy of ABT101.
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