Atamparib in advanced NSCLC and other solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, non-randomized phase Ib/II study evaluating atamparib in patients with unresectable or metastatic NSCLC adenocarcinoma and other solid tumors. It uses a dose-escalation phase to identify a recommended dose, followed by an expansion phase to further assess safety and preliminary anti-tumor activity. Key endpoints include safety, tolerability, pharmacokinetics, and signs of efficacy in KRAS-mutant NSCLC and eligible solid tumors. Eligible participants have prior therapy, measurable disease, good performance status, and adequate organ function. Exclusion criteria include non-adenocarcinoma NSCLC, other actionable drivers without effective therapy, active GI issues affecting absorption, significant cardiac disease, certain drug interactions, and untreated CNS lesions.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Caicun Zhou, Dr. — Shanghai East Hospital, Yuntailu 1800
• Study coordinator: Olivia Chi Operations Program Lead, Master
• Email: olivia.chi@nervianoms.com
• Phone: 86 18621117100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.