Atamparib in Patients With Advanced Solid Tumors (PARP7)

January 25, 2026 updated by: Nerviano Medical Sciences (Shanghai) Ltd.

A Phase Ib/II Study of 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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

178

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Qin Kang, Senior Project manager, Tigermed, bachelor
  • Phone Number: 86 158 5828 6160
  • Email: qin.kang@tigermedgrp.com

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Unit 3.53, 3rd Floor, No. 5, Lane 720 Cailun Road, Pilot Free Trade Zone, Shanghai, P.R.China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: monotherapy escalation
Atamparib
Drug: atamparib escalation levels
Bid, Oral, escalating at different dose levels
Experimental: Espansion Arm a
Atamparib
Drug: atamparib RP2D
Bid, oral, RP2D
Experimental: Expansion Arm b
Atamparib
Drug: atamparib RP2D
Bid, oral, RP2D
Experimental: Expansion Arm c
Atamparib
Drug: atamparib RP2D
Bid, oral, RP2D
Experimental: Expansion Arm d
Atamparib
Drug: atamparib RP2D
Bid, oral, RP2D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RP2D and MTD
Time Frame: 28 days after the last dose
First cycle DLTs and all other available study data
28 days after the last dose
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
until 28 days after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nerviano Medical Sciences (Shanghai) Ltd.

Investigators

  • Principal Investigator: Caicun Zhou, Dr., Shanghai East Hospital, Yuntailu 1800

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 25, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP7A-ATA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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