Atamparib in Patients With Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNerviano Medical Sciences (Shanghai) Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
Subject must be ≥18 years of age.
Histologically confirmed diagnosis of unresectable advanced or metastatic NSCLC adenocarcinoma.
Documented KRAS mutation status at study entry.
Have received at least one line of standard therapy and experienced radiographic tumor progression to the last administered treatment and have failed institutional standards of care.
Disqualifiers
Non-adenocarcinoma histology of NSCLC. Patients whose tumors have a mixed histology are ineligible.
Wtih oncogenic driver mutation other than KRAS for which an approved therapy is available but not adequately treated.
Known active GI disease that would impact the absorption
Clinically significant cardiac disease
Trial design
Treatments tested in this trial
- atamparib escalation levels
- atamparib RP2D
Treatment groups
178 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov