Study to Evaluate D-1553 in Subjects With Solid Tumors

NSCLC Clinical Trial

Official title:

A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04585035
• Other study ID #: D1553-101
• Secondary ID: KEYNOTE-C15 MK34
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2, 2020
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: InventisBio Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1/2, open label study of D-1553 single agent and combination treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: February 2025
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, for which no standard treatment is available, or the subject is refractory to or intolerant of existing standard treatment.
• Subject has KRasG12C mutation in tumor tissue or other bio-specimens containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a central laboratory.
• Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
• Subject has measurable disease according to RECIST, v1.1.

Exclusion Criteria:

• Subject with unstable or progressive central nervous system (CNS) metastases.
• Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.
• Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is > 480 msec based on triplicate measurements of electrocardiogram (ECG).
• Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;
• Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection;
• Subject has any history or evidence of substance abuse or medical, psychological or social conditions that may, in the opinion of the investigator, interfere with participation in the study or evaluation of the study results.
• Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
• Subject has unresolved toxicities from prior anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE, v5.0, Grade = 1 (Grade = 2 for peripheral neuropathy).
• Subject had major surgery within 4 weeks prior to study intervention administration or last dose of palliative radiation therapy within 2 weeks prior to study intervention administration.
• Subject is pregnant or lactating.

Related Conditions & MeSH terms

• CRC
• Neoplasms
• NSCLC
• Solid Tumor, Adult

Intervention

Drug:
• D-1553
D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.
• D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other
Standard treatment of solid tumor, NSCLC or CRC

Locations

Country	Name	City	State
Australia	Research Site	Blacktown	New South Wales
Australia	Research Site	East Albury	New South Wales
Australia	Research Site	Fitzroy	Victoria
Australia	Research Site	Frankston	Victoria
Australia	Research Site	Kogarah	New South Wales
Australia	Research Site	Malvern	Victoria
Australia	Research Site	Nedlands	Western Australia
Australia	Research Site	Waratah	New South Wales
Australia	Research Site	Woodville South	South Australia
Korea, Republic of	Research Site	Seogu	Busan
Korea, Republic of	Research Site	Seongnam-si	Gyeonggi-Do
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei City
Taiwan	Research Site	Taoyuan City
United States	Research Site	Detroit	Michigan
United States	Research Site	Fresno	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	New York	New York
United States	Research Site	Orange	California
United States	Research Site	Portland	Oregon
United States	Research Site	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
InventisBio Co., Ltd	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of Dose-limiting toxicities (DLT)		through out the DLT period, approximately 21 days
Primary	Number of subjects participants with adverse events		Through study completion, approximately 3 years
Primary	Plasma concentration of D-1553 as a single agent or in combination with other therapies in subjects wiht advanced or metastatic solid tumors with KRas G12C mutation.		Through study completion, approximately 3 years