Not Yet RecruitingPhase 1/2

Atamparib in Patients With Advanced Solid Tumors

China178 participantsStarted 2026-02-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Have measurable tumor lesions
✓. ECOG 0-1
✓. Adequate organ functions

Exclusion criteria

✕. 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
✕. Requiring the administration of strong inhibitors or inducers of CYP3A4, P-gp or BCRP.
✕. Symptomatic, or untreated CNS lesions.

What they're measuring

RP2D and MTD

Timeframe: 28 days after the last dose

Type, incidence and severity of adverse event

Timeframe: until 28 days after the last dose

Trial details

NCT IDNCT07374419

SponsorNerviano Medical Sciences (Shanghai) Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07-31

Contact for this trial

Olivia Chi Operations Program Lead, Master

86 18621117100 olivia.chi@nervianoms.com

View on ClinicalTrials.gov More NSCLC Adenocarcinoma trials