NSCLC
Conditions
Brief summary
This is a Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combination Therapy in Subjects with KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Interventions
DRUGD-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.
DRUGOther
Standard treatment of NSCLC.
Sponsors
InventisBio Co., 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
* Subject with histologically proven, locally advanced or metastatic NSCLC for which has no standard treatment or the subject has been previously treated with first- or second-line systemic therapy. * Subject has KRasG12C mutation in tumor tissue or other biospecimens 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 local laboratory. * Subject has measurable disease according to RECIST v1.1. For phase 1b subjects who have no measurable lesions but whose disease can be evaluated are also acceptable.
Exclusion criteria
* Subject with unstable or progressive central nervous system (CNS) metastases. * Subjects with clinically significant cardiovascular disease. * Subject with interstitial lung disease (ILD) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. * Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications. * Subject is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject incidence of Dose-limiting toxicities (DLT) | Through out the DLT period, approximately 21 days | Subject incidence of Dose-limiting toxicities (DLT) |
| Number of subjects participants with adverse events | Till study completion, approximately 3 years | Number of subjects participants with adverse events |
| Antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation | Till study completion, approximately 3 years | Overall Response Rate (ORR, Complete Response \[CR\] + Partial Response \[PR\]) |
Countries
China
Outcome results
None listed