NCT05383898CompletedPhase 1/2
Study to Evaluate D-1553 in Subjects With Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
This is a phase 1/2, open label study of D-1553 single agent 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 NSCLC with KRasG12C mutation
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 225 (actual)
- First submitted
- 13 May 2022
- Start date
- 16 Mar 2021
- Primary completion date
- 17 Nov 2023
- Lead sponsor
- InventisBio Co., Ltd
- Diseases
- Lung cancer
- NCT number
- NCT05383898
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 225
- From 16 Mar 2021 to the primary completion date, 17 Nov 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Subject with unstable or progressive central nervous system (CNS) metastases.
- Subject is pregnant or lactating.
Who the study is looking for
- Subject with histologically proven, locally advanced, unresectable and/or metastatic NSCLC 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 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 central laboratory.
- Subject has measurable disease according to RECIST, v1.1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital (Cancer Hospital of the University of Chinese Academy of Sciences) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
- Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: A pooled analysis of phase 1/2 study.Eur J Cancer · 2026 · PMID 41330054
This page is information, not medical advice. Discuss any trial with your doctor.