This is a multi-part, open-label, non-randomized phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of atamparib, an investigational agent, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) adenocarcinoma. The study comprises dose escalation (phase Ib) and expansion (phase II).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Bid, Oral, escalating at different dose levels
Bid, oral, RP2D
Unit 3.53, 3rd Floor, No. 5, Lane 720 Cailun Road, Pilot Free Trade Zone, Shanghai, P.R.China
Shanghai, Shanghai Municipality, China
RP2D and MTD
First cycle DLTs and all other available study data
Time frame: 28 days after the last dose
Type, incidence and severity of adverse event
Safety and tolerability profile assessed by the CTCAE v6.0
Time frame: until 28 days after the last dose
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