Advanced Solid Tumor
Conditions
Brief summary
An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors.
Detailed description
This is an open-label, multi-center Phase 1/2 study in participants with advanced solid tumors, including RET fusion-positive NSCLC, MTC, and other tumors with RET activation. Phase I of this study includes a dose-escalation phase and a dose-expansion phase , which will focus on exploring MTD and/or RP2D of HEC169096 in patients with advanced solid tumours; Phase II will assess the efficacy and safety of HEC169096 at the RP2D dose.
Interventions
DRUGHEC169096
Multiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2.
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Phase 1：Pathologically documented, definitively diagnosed non-resectable advanced solid tumor. * Phase 2： All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor. * Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. * Measurable or non-measurable disease as determined by RECIST 1.1; * Adequate hematologic, hepatic and renal function; * Life expectancy of at least 12 weeks; * Negative pregnancy test (urine or serum) for female patients of childbearing potential; * Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy).
Exclusion criteria
* Participant's cancer has a known primary driver alteration other than RET. * Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment; * Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment; * Those who have received more than 30% of bone marrow radiation or wide-range radiotherapy within 4 weeks before the first study drug treatment (the patients receiving palliative radiotherapy are within 2 weeks before receiving study drug treatment); * Had received traditional Chinese medicine for anti-tumor within a week before receiving study drug treatment; * Had received live vaccine within 4 weeks prior to study treatment; * Had received any investigational agent from other clinical study within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment or are currently participating in other clinical trials; * Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment . * Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms. * Patients with other malignant tumors within 5 years before the first use of drugs * Patients have a history of severe cardiovascular disease; * Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU/ mL or ≥ 10\^4 cps/ mL; Hepatitis B: HCV antibody-positive and HCV-RNA positive), HIV antibody-positive. * Patients with clinically active interstitial lung disease, active pneumonia, and radiation pneumonia requiring treatment; * Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage); * Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption; * Patients have been treated with any strong CYP3A inhibitors or inducers within 2 weeks prior to the first dose or PPIs in the first week before the first dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: MTD and RP2D of HEC169096 | Cycle 1 (28 days) of treatment for MTD and at the end of every 2 cycle for RP2D for approximately 12 months or earlier if participant terminates from the study | Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of HEC169096 |
| Phase 2: Overall Response Rate | through study completion, an average of 1 year | As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) |
Countries
China
Outcome results
None listed