HEC169096 treatment for advanced solid tumors

Phase 1/2 Study of the Highly-selective RET Inhibitor,HEC169096 in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

This study is testing a new treatment called HEC169096 to see if it can safely help people with advanced solid tumors, like certain lung and thyroid cancers.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 456 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sunshine Lake Pharma Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Guangzhou)
• Trial ID: NCT05451602 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, and effectiveness of HEC169096 in patients with advanced solid tumors, including specific types of lung and thyroid cancers. It consists of a Phase I dose-escalation and dose-expansion phase to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D), followed by a Phase II assessment of efficacy and safety at the RP2D. The study is open-label and multi-center, allowing for a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with pathologically documented, non-resectable advanced solid tumors that have oncogenic RET-rearrangements or mutations.

Not a fit: Patients whose cancer has a known primary driver alteration other than RET may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors harboring RET alterations.

How similar studies have performed: Other studies targeting RET alterations in solid tumors have shown promise, indicating potential for success with this approach.

Eligibility criteria

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.

Where this trial is running

Guangzhou

• GuangDong Province Peoples Hospital — Guangzhou, China (Recruiting)

Conditions Advanced Solid Tumor