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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monotherapy escalation | Experimental | Atamparib |
|
| Espansion Arm a | Experimental | Atamparib |
|
| Expansion Arm b | Experimental | Atamparib |
|
| Expansion Arm c | Experimental | Atamparib |
|
| Expansion Arm d | Experimental | Atamparib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atamparib escalation levels | Drug | Bid, Oral, escalating at different dose levels |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivia Chi Operations Program Lead, Master | Contact | 86 18621117100 | olivia.chi@nervianoms.com | |
| Qin Kang, Senior Project manager, Tigermed, bachelor | Contact | 86 158 5828 6160 | qin.kang@tigermedgrp.com |
| Name | Affiliation | Role |
|---|---|---|
| Caicun Zhou, Dr. | Shanghai East Hospital, Yuntailu 1800 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit 3.53, 3rd Floor, No. 5, Lane 720 Cailun Road, Pilot Free Trade Zone, Shanghai, P.R.China | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D009459 | Neuroleptic Malignant Syndrome |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| atamparib RP2D |
| Drug |
Bid, oral, RP2D |
|
| D020258 | Neurotoxicity Syndromes |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |