Study to Evaluate D-1553 in Subjects With Solid Tumors
Phase 1
Active, not recruiting
- Conditions
- NSCLCCRCSolid Tumor, Adult
- Interventions
- Drug: D-1553
- Registration Number
- NCT04585035
- Lead Sponsor
- InventisBio Co., Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
Not provided
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose escalation of D-1553 monotherapy D-1553 Phase 1a will evaluate up to 7 sequential cohorts with different doses of D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation. Dose combination of D-1553 with other therapies D-1553 Phase 1b will determine the MTD of D-1553 in combination treatment in subjects with advanced or metastatic NSCLC, CRC and other solid tumors. There are multiple groups in Phase 1b for different tumor types and treatment combinations to evaluate safety, MTD and RP2D. Phase 2 of D-1553 monotherapy and combination therapies D-1553 The Phase 2 portion is a multi-arm, parallel, open label study to evaluate the efficacy of D- 1553 single agent and combination treatments in subjects with advanced or metastatic solid tumors with KRas G12C mutation. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose.
- Primary Outcome Measures
Name Time Method 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 Subject incidence of Dose-limiting toxicities (DLT) through out the DLT period, approximately 21 days Number of subjects participants with adverse events Through study completion, approximately 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇨🇳Taoyuan City, Taiwan