HEC169096 in Participants With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HEC169096 Multiple doses of HEC169096 |
Drug: HEC169096
Multiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2.
|
Outcome Measures
Primary Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Phase 1：Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.
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Phase 2： All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor.
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Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
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Measurable or non-measurable disease as determined by RECIST 1.1;
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Adequate hematologic, hepatic and renal function;
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Life expectancy of at least 12 weeks;
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Negative pregnancy test (urine or serum) for female patients of childbearing potential;
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Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy).
Exclusion Criteria:
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Participant's cancer has a known primary driver alteration other than RET.
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Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment;
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Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment;
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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);
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Had received traditional Chinese medicine for anti-tumor within a week before receiving study drug treatment;
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Had received live vaccine within 4 weeks prior to study treatment;
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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;
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Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment .
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Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms.
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Patients with other malignant tumors within 5 years before the first use of drugs
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Patients have a history of severe cardiovascular disease;
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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.
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Patients with clinically active interstitial lung disease, active pneumonia, and radiation pneumonia requiring treatment;
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Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage);
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Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption;
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sunshine Lake Pharma Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HEC169096-ST-101