NSCLC Adenocarcinoma, Solid Tumor
Conditions
Keywords
PRP7A-ATA-001, Atamparib, Neviano, NMS
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).
Interventions
DRUGatamparib escalation levels
Bid, Oral, escalating at different dose levels
DRUGatamparib RP2D
Bid, oral, RP2D
Sponsors
Nerviano Medical Sciences (Shanghai) Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RP2D and MTD | 28 days after the last dose | First cycle DLTs and all other available study data |
| Type, incidence and severity of adverse event | until 28 days after the last dose | Safety and tolerability profile assessed by the CTCAE v6.0 |
Countries
China
Contacts
CONTACTOlivia Chi Operations Program Lead, Master
CONTACTQin Kang, Senior Project manager, Tigermed, bachelor
PRINCIPAL_INVESTIGATORCaicun Zhou, Dr.
Shanghai East Hospital, Yuntailu 1800
Outcome results
None listed