D-0316 First Time in Patients Ascending Dose Study

• ClinicalTrials.gov Identifier: NCT03452150
• Recruitment Status: Active, not recruiting
• First Posted: March 2, 2018
• Last Update Posted: February 10, 2021
• Sponsor: InventisBio Inc.
• Information provided by (Responsible Party): InventisBio Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Advanced Non Small Cell Lung Cancer	Drug: D-0316	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study of D-0316 in Patients With Advanced Non Small Cell Lung Cancer With Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase
• Actual Study Start Date: January 3, 2018
• Estimated Primary Completion Date: May 1, 2021
• Estimated Study Completion Date: August 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Daily oral dose of D-0316	Drug: D-0316; If initial dosing of D-0316 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined

Outcome Measures

Primary Outcome Measures :

1. Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 - Day 28 ]
   Incidence of DLTs
2. Adverse events [ Time Frame: Day 1 - Day 28 ]
   Incidence of AEs
3. Laboratory results [ Time Frame: Day 1 - Day 28 ]
   Incidence of laboratory abnormalities
4. Vital signs [ Time Frame: Day 1 - Day 28 ]
   Incidence of vital sign abnormalities
5. Electrocardiogram [ Time Frame: Day 1 - Day 28 ]
   Incidence of ECG abnormalities

Secondary Outcome Measures :

1. Pharmacokinetic: area under the plasma concentration versus time curve (AUC) [ Time Frame: Day 1 through 6, Cycle Day 1-Day 15 ]
   AUC: area under the plasma concentration versus time curve for D-0316
2. Pharmacokinetic: maximum plasma drug concentration (Cmax) [ Time Frame: Day 1 through 6, Cycle Day 1-Day 15 ]
   Cmax: maximum plasma drug concentration of D-0316
3. Pharmacokinetic: Time to reach the Cmax (Tmax) [ Time Frame: Day 1 through 6, Cycle Day 1-Day 15 ]
   tmax: Time to reach the Cmax of D-0316
4. Pharmacokinetic: Apparent terminal half-life (t1/2) [ Time Frame: Day 1 through 6, Cycle Day 1-Day 15 ]
   t1/2: apparent terminal half-life of D-0316
5. Antitumor activity [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Jilin

Research Site

Changchun, Jilin, China, 130012

China, Shanghai

Research Site

Shanghai, Shanghai, China, 200030

China, Zhejiang

Research Site

Hangzhou, Zhejiang, China, 310052

Sponsors and Collaborators

InventisBio Inc.

More Information

• Responsible Party: InventisBio Inc.
• ClinicalTrials.gov Identifier: NCT03452150
• Other Study ID Numbers: XY-101
• First Posted: March 2, 2018
• Last Update Posted: February 10, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms