D-0316 First Time in Patients Ascending Dose Study

Phase 1

Completed

• Conditions: Advanced Non Small Cell Lung Cancer
• Interventions: Drug: D-0316

• Registration Number: NCT03452150
• Lead Sponsor: InventisBio Co., Ltd

Brief Summary

This is a phase 1 open label multicentre study of D-0316 administered orally in patients with advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-02
• Primary Completion: 2020-08-28
• Study Completion: 2020-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
• Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).
• Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib. In addition other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
• Confirmation that the tumour harbours an EGFR T790M mutation.
• No deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
• Evaluable or measurable disease per RECIST v1.1

Exclusion Criteria

• Treatment with an EGFR TKI (erlotinib or gefitinib) within 14 days of the first dose of study treatment.
• Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.

Other protocol defined inclusion/exclusion criteria could apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daily oral dose of D-0316	D-0316	-

Primary Outcome Measures

Name	Time	Method
Adverse events	Day 1 - Day 28	Incidence of AEs
Dose Limiting Toxicities (DLTs)	Day 1 - Day 28	Incidence of DLTs
Laboratory results	Day 1 - Day 28	Incidence of laboratory abnormalities
Vital signs	Day 1 - Day 28	Incidence of vital sign abnormalities
Electrocardiogram	Day 1 - Day 28	Incidence of ECG abnormalities

Secondary Outcome Measures

Name	Time	Method
Antitumor activity	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months	Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Pharmacokinetic: Apparent terminal half-life (t1/2)	Day 1 through 6, Cycle Day 1-Day 15	t1/2: apparent terminal half-life of D-0316
Pharmacokinetic: maximum plasma drug concentration (Cmax)	Day 1 through 6, Cycle Day 1-Day 15	Cmax: maximum plasma drug concentration of D-0316
Pharmacokinetic: Time to reach the Cmax (Tmax)	Day 1 through 6, Cycle Day 1-Day 15	tmax: Time to reach the Cmax of D-0316
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)	Day 1 through 6, Cycle Day 1-Day 15	AUC: area under the plasma concentration versus time curve for D-0316

Trial Locations

Locations (1)

Research Site; 🇨🇳 Hangzhou, Zhejiang, China