HEC169096 in Participants With 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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: HEC169096

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 Type: Interventional
• Enrollment (Estimated): 456
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • GuangDong Province Peoples Hospital
    • Contact: Haiyan Tu; Phone Number: 13798012949; Email: tuhaiyan@gdph.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: MTD and RP2D of HEC169096	Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (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
Phase 2: Overall Response Rate	As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HEC169096-ST-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No