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Recruiting Phase 1/2

Atamparib in Patients With Advanced Solid Tumors

NCT07374419 · tracked via the Priya Life Science China tracker
Sponsor
Nerviano Medical Sciences (Shanghai) Ltd
Phase
Phase 1/2
Started
2026-03-18
Last updated
2026-07-29

Condition(s) studied

NSCLC AdenocarcinomaSolid Tumor

Investigational drug(s) / intervention(s)

atamparib escalation levelsatamparib RP2D

atamparib escalation levels: Bid, Oral, escalating at different dose levels

atamparib RP2D: Bid, oral, RP2D

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: 1. Subject must be ≥18 years of age. 2. Histologically confirmed diagnosis of unresectable advanced or metastatic NSCLC adenocarcinoma. 3. Documented KRAS mutation status at study entry. 4. 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. 5. Have measurable tumor lesions 6. ECOG 0-1 7. Adequate organ functions Exclusion criteria: 1. Non-adenocarcinoma histology of NSCLC. Patients whose tumors have a mixed histology are ineligible. 2. Wtih oncogenic driver mutation other than KRAS for which an approved therapy is available but not adequately treated. 3. Known active GI disease that would impact the absorption 4. Clinically significant cardiac disease 5. Requiring the administration of strong inhibitors or inducers of CYP3A4, P-gp or BCRP. 6. Symptomatic, or untreated CNS lesions.

Primary outcome measure(s)

  • RP2D and MTD — 28 days after the last dose
    First cycle DLTs and all other available study data
  • Type, incidence and severity of adverse event — until 28 days after the last dose
    Safety and tolerability profile assessed by the CTCAE v6.0

Trial sites (1)

FacilityCityRegionStatus
Unit 3.53, 3rd Floor, No. 5, Lane 720 Cailun Road, Pilot Free Trade Zone, Shanghai, P.R.China Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07374419 on ClinicalTrials.gov ↗ ← All trials in China