Atamparib in Patients With Advanced Solid Tumors
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
atamparib escalation levels
DrugBid, Oral, escalating at different dose levels
atamparib RP2D
DrugBid, oral, RP2D
Treatment groups
178 Participants
are divided into 5 treatment groupsGroup A: monotherapy escalationExperimental treatment 1 intervention
Group B: Espansion Arm aExperimental treatment 1 intervention
Group C: Expansion Arm bExperimental treatment 1 intervention
Group D: Expansion Arm cExperimental treatment 1 intervention
Group E: Expansion Arm dExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
RP2D and MTD
First cycle DLTs and all other available study data
Time frame
28 days after the last dose2
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 doseSponsors and contacts
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Source ClinicalTrials.gov