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New treatment option for Advanced Solid Tumor
Official title HEC169096 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05451602
What this study is testing
What is HEC169096?
HEC169096 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- 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;
You likely can't join if
- 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...
- 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;
See the full eligibility 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.