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NCT Number: NCT07374419

Atamparib in Patients With Advanced Solid Tumors

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).

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Key information

Conditions

NSCLC Adenocarcinoma Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chemically-Induced Disorders Nervous System Diseases Neuroleptic Malignant Syndrome Neurotoxicity Syndromes Poisoning Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Unit 3.53, 3rd Floor, No. 5, Lane 720 Cailun Road, Pilot Free Trade Zone, Shanghai, P.R.China

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atamparib escalation levels

Drug

Bid, Oral, escalating at different dose levels

atamparib RP2D

Drug

Bid, oral, RP2D

Primary outcomes

  1. RP2D and MTD

    Time frame: 28 days after the last dose

    First cycle DLTs and all other available study data

  2. Type, incidence and severity of adverse event

    Time frame: until 28 days after the last dose

    Safety and tolerability profile assessed by the CTCAE v6.0

Study contacts

Contact information is provided by the study sponsor or research team.

Olivia Chi Operations Program Lead, Master

CONTACT

[email protected]

86 18621117100

Qin Kang, Senior Project manager, Tigermed, bachelor

CONTACT

[email protected]

86 158 5828 6160

Sponsors and collaborators

Lead sponsor

Nerviano Medical Sciences (Shanghai) Ltd.

Industry

Registry information

Official study title

A Phase Ib/II Study of Atamparib in Patients With Advanced Solid Tumors

Acronym: PARP7

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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