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Recruiting NCT07374419

Atamparib in Patients With Advanced Solid Tumors

Phase I / Phase II Interventional NSCLC Adenocarcinoma Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: atamparib escalation levels, atamparib RP2D.
Who it may be relevant to
Registry conditions: NSCLC Adenocarcinoma, Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug atamparib escalation levels
    Bid, Oral, escalating at different dose levels
  • Drug atamparib RP2D
    Bid, oral, RP2D

Primary outcome measures

  • RP2D and MTD [Time frame: 28 days after the last dose]
  • Type, incidence and severity of adverse event [Time frame: until 28 days after the last dose]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Unit 3.53, 3rd Floor, No. 5, Lane 720 Cailun Road, Pilot Free Trade Zone, Shanghai, P.R.Ch — Shanghai

Identifiers

NCT: NCT07374419 · PRP7A-ATA-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗