A Study to Evaluate D-1553 in Combination Therapy in Non-Small Cell Lung Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Phase 1b Dose escalation of D-1553 combination therapies Phase 1b will determine maximal tolerated dose and/or recommended phase 2 dose of D-1553 in combination with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. |
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.
Drug: Other
Standard treatment of NSCLC.
|
| Experimental: Phase 2 of D-1553 combination therapies Phase 2 will evaluate the efficacy and safety of D-1553 combined with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. |
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.
Drug: Other
Standard treatment of NSCLC.
|
Outcome Measures
Primary Outcome Measures
- 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])
Eligibility Criteria
Criteria
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.
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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.
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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:
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Subject with unstable or progressive central nervous system (CNS) metastases.
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Subjects with clinically significant cardiovascular disease.
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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.
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Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
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Subject is pregnant or lactating.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Chest Hospital | Shanghai | Shanghai | China | 200030 |
| 2 | Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences | Hangzhou | Zhejiang | China | 310005 |
Sponsors and Collaborators
- InventisBio Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1553-105