HEC169096 in Participants With Advanced Solid Tumors

NCT05451602 | Recruiting Phase 1

• 1 other identifier: HEC169096-ST-101
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

HEC169096

EXPERIMENTAL

Multiple doses of HEC169096

Drug: HEC169096

Interventions

HEC169096 DRUG

Multiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2.

HEC169096

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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) 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).

You may not qualify 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 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;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

GuangDong Province Peoples Hospital

Guangzhou, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 11, 2022
• Study Start: October 21, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)