NSCLC AdenocarcinomaPhase 1/2PARP7NCT07374419
Atamparib in Patients With Advanced Solid Tumors
A Phase 1/2 study testing atamparib escalation levels and atamparib RP2D in people with NSCLC Adenocarcinoma and Solid Tumor, run by Nerviano Medical Sciences (Shanghai) Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Adenocarcinoma, Solid Tumor
- What is being tested?
- atamparib escalation levels and atamparib RP2D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2026to 31 Jan 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qin Kang, Senior Project manager, Tigermed, bachelor contact
China1 site, 1 recruiting
- Recruiting
Unit 3.53, 3rd Floor, No. 5, Lane 720 Cailun Road, Pilot Free Trade Zone, Shanghai, P.R.China
Shanghai, Shanghai Municipality, 200000
Olivia Chi, Master, 86 18621117100, Olivia.Chi@nervianoms.com
Caicun zhou, MD
About this study
Official title: 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).
- Conditions
- NSCLC Adenocarcinoma, Solid Tumor
- Being tested
- atamparib escalation levels, atamparib RP2D
- Keywords
- PRP7A-ATA-001, Atamparib, Neviano, NMS
- Medical subject headings
- Neuroleptic Malignant Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atamparib escalation levelsDrug
Bid, Oral, escalating at different dose levels
atamparib RP2DDrug
Bid, oral, RP2D
| Study group | Role | What they receive |
|---|---|---|
| monotherapy escalation | Experimental | Atamparib Receives: Drug: atamparib escalation levels |
| Espansion Arm a | Experimental | Atamparib Receives: Drug: atamparib RP2D |
| Expansion Arm b | Experimental | Atamparib Receives: Drug: atamparib RP2D |
| Expansion Arm c | Experimental | Atamparib Receives: Drug: atamparib RP2D |
| Expansion Arm d | Experimental | Atamparib Receives: Drug: atamparib RP2D |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D and MTD
First cycle DLTs and all other available study data
Measured: 28 days after the last dose
Type, incidence and severity of adverse event
Safety and tolerability profile assessed by the CTCAE v6.0
Measured: until 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start18 Mar 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nerviano Medical Sciences (Shanghai) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Dr., Principal investigator, Shanghai East Hospital, Yuntailu 1800
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374419
- Sponsor's protocol ID
- PRP7A-ATA-001
- Acronym
- PARP7
- Status last verified
- Jul 2026
- First submitted
- 6 Jan 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of Atamparib in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07374419
- Acronym / sponsor ID
- PARP7 / PRP7A-ATA-001
- Conditions
- NSCLC Adenocarcinoma, Solid Tumor
- Keywords
- PRP7A-ATA-001, Atamparib, Neviano, NMS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Nerviano Medical Sciences (Shanghai) Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| monotherapy escalation | Experimental | Drug: atamparib escalation levelsAtamparib |
| Espansion Arm a | Experimental | Drug: atamparib RP2DAtamparib |
| Expansion Arm b | Experimental | Drug: atamparib RP2DAtamparib |
| Expansion Arm c | Experimental | Drug: atamparib RP2DAtamparib |
| Expansion Arm d | Experimental | Drug: atamparib RP2DAtamparib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atamparib escalation levelsBid, Oral, escalating at different dose levels | Drug | monotherapy escalation |
| atamparib RP2DBid, oral, RP2D | Drug | Espansion Arm a, Expansion Arm b, Expansion Arm c, Expansion Arm d |
Primary outcome
RP2D and MTD
Time frame: 28 days after the last dose
First cycle DLTs and all other available study data
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for NSCLC Adenocarcinoma
RecruitingPhase 1
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
Solid Tumor, Adult, Metastatic Solid Tumor
RecruitingPhase 1/2
A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors
MTAP-deleted Solid Tumors
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced Cancer
RecruitingPhase 2
Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma
NSCLC, EGFR Positive Non-small Cell Lung Cancer
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qin Kang, Senior Project manager, Tigermed, bachelor contact
Caicun Zhou, Dr. principal investigator
Shanghai East Hospital, Yuntailu 1800
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing atamparib escalation levels and atamparib RP2D in people with NSCLC Adenocarcinoma and Solid Tumor, run by Nerviano Medical Sciences (Shanghai) Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Chi Operations Program Lead, Master (86 18621117100, olivia.chi@nervianoms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP2D and MTD (time frame: 28 days after the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.