NCT07374419

Brief 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).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for phase_1

Timeline
33mo left

Started Feb 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026Jan 2029

First Submitted

Initial submission to the registry

January 6, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

January 6, 2026

Last Update Submit

January 25, 2026

Conditions

Solid TumorNSCLC Adenocarcinoma

Keywords

PRP7A-ATA-001, AtamparibNeviano, NMS

Outcome Measures

Primary Outcomes (2)

  • RP2D and MTD

    First cycle DLTs and all other available study data

    28 days after the last dose

  • Type, incidence and severity of adverse event

    Safety and tolerability profile assessed by the CTCAE v6.0

    until 28 days after the last dose

Study Arms (5)

monotherapy escalation

EXPERIMENTAL

Atamparib

Drug: atamparib escalation levels

Espansion Arm a

EXPERIMENTAL

Atamparib

Drug: atamparib RP2D

Expansion Arm b

EXPERIMENTAL

Atamparib

Drug: atamparib RP2D

Expansion Arm c

EXPERIMENTAL

Atamparib

Drug: atamparib RP2D

Expansion Arm d

EXPERIMENTAL

Atamparib

Drug: atamparib RP2D

Interventions

atamparib RP2DDRUG

Bid, oral, RP2D

Espansion Arm aExpansion Arm bExpansion Arm cExpansion Arm d
atamparib escalation levelsDRUG

Bid, Oral, escalating at different dose levels

monotherapy escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Neuroleptic Malignant Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurotoxicity SyndromesPoisoningChemically-Induced Disorders

Study Officials

  • Caicun Zhou, Dr.

    Shanghai East Hospital, Yuntailu 1800

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Chi Operations Program Lead, Master

CONTACT

86 18621117100olivia.chi@nervianoms.com

Qin Kang, Senior Project manager, Tigermed, bachelor

CONTACT

86 158 5828 6160qin.kang@tigermedgrp.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 28, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

January 31, 2029

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

CN(1)