Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

The dose levels will be escalated following a modified 3+3 dose escalation scheme.

IMP4297(senaparib)

Min Song

Asia Beamon

Kirstie Armstrong

Nancy Zangmeister

Brittany Callaway

Debbie Metcalf

Grace Murray

Carol Han

Linda Raineri

Xiaoling Chen

Ying Cheng

Yan Wang

Jing Zhang

So Yun Yun

Jung Soon Kim

Lee Seul Gi

Kang Yoonsook

Pei-Chen Hsu

Hsiang-Lien Li

Lillian Lee

Shu-Ling Chang

Hsiao-Ying Yang

This is an open-label, multi-center, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, PK characteristics and anti-tumor activity of PARP inhibitor IMP4297 and temozolomide combination therapy in patients with advanced solid tumors and with ES-SCLC who develops disease progression after 1L platinum-based regimen.

This study will be conducted in two parts. Part I of the study will be dose escalation evaluation to determine the MTD and/or recommended phase 2 dose（RP2D） of IMP4297 in combination with temozolomide. Part II of the study will be conducted in two expansion cohorts (sensitive ES-SCLC cohort and resistant ES-SCLC cohort) to further evaluate the anti-tumor activity, safety and tolerability of this regimen in ES-SCLC patients.

IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer

A Phase Ib/II, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer

TEAEs, vital signs, physical examinations, electrocardiogram (ECG), laboratory tests (including serum chemistry, hematology, and urinalysis, coagulation), etc.

the maximum tolerated dose:the highest dose level at which \<1/3 patients experience DLT

the percentage of patients who had a best response rating of CR and PR which was maintained ≥4 weeks from the first manifestation of that rating.

To characterize the plasma PK profile of IMP4297 and temozolomide via population PK (popPK) modeling

Progression-free survival (PFS),Duration of response (DoR),Disease control rate (DCR)

Correlation between IMP4297 plasma concentration and QT interval

TEAE, vital signs, physical examinations, ECG, laboratory tests (including serum chemistry, hematology, urinalysis and coagulation), etc.

progression-free survival (PFS ),duration of response (DoR),Disease control rate （DCR),overall survival (OS)

PK parameters derived from IMP4297 and temozolomide plasma concentration data

Spots Global Cancer Trial Database for imp4297(senaparib)