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Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (KAT6A/B Small Molecule Inhibitor) in Patients With Advanced/Metastatic Solid Tumor

NCT07480681•Shanghai Henlius Biotech

View on ClinicalTrials.gov

Summary

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary efficacy of HLX97 ( KAT6A/B inhibitor) in patients with advanced/metastatic solid tumors.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
•18-80 years of age, either sex;
•Subjects who meet the corresponding requirements below will be enrolled.
•1. Part 1A will enroll subjects with histologically or cytologically confirmed advanced/metastatic HR-positive, HER2-negative breast cancer (BC), castration-resistant prostate cancer (CRPC), or non-small cell lung cancer (NSCLC) who have failed standard therapy or for whom no standard therapy exists.
•2. Part 1B will enroll subjects with histologically or cytologically confirmed advanced or metastatic HR-positive, HER2-negative breast cancer.
•3. Part 2 will enroll subjects with histologically or cytologically confirmed advanced or metastatic HR-positive, HER2-negative breast cancer.
•ECOG performance status of 0-1;
•Life expectancy ≥ 12 weeks;
•Adequate bone marrow and organ function.
•Presence of residual toxicity from prior anti-tumor therapy that has not resolved, defined as toxicity not resolved to Grade ≤1 or baseline levels per CTCAE V5.0 (alopecia excepted).
+7 more criteria

Exclusion Criteria

•History of any second malignancy within 3 years prior to signing the ICF. Exceptions include early-stage malignancies (carcinoma in situ or Stage I tumors) that have been curatively treated, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, or papillary thyroid cancer.
•Active systemic infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose.
•Subjects with poorly controlled clinical symptoms or diseases of the cardiovascular and cerebrovascular system, including but not limited to:
•NYHA Class ≥II heart failure or left ventricular ejection fraction (LVEF) \< 50%; Unstable angina; Myocardial infarction or cerebrovascular accident within 6 months (excluding lacunar infarction, minor cerebral ischemia, or transient ischemic attack); Poorly controlled arrhythmias (including QTc interval ≥450 ms for males or ≥470 ms for females, calculated using the Fridericia formula); Poorly controlled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg despite active treatment).

Key Dates

Start Date

March 1, 2026

Primary Completion Date

March 1, 2028

Completion Date

June 1, 2028

Last Updated

March 18, 2026

Enrollment

138

ESTIMATED participants

Conditions

Advanced/Metastatic Solid Tumors

Interventions

HLX97

DRUG

Fulvestrant

DRUG

Contacts

Zhixin Yu

CONTACT

021-22200000 zhixin_yu@henlius.com

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Advanced/Metastatic Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor

Inclusion Criteria

Exclusion Criteria

A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced/Metastatic Solid Tumors

HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumours

Study of NMS-1116354 in Advanced/Metastatic Solid Tumors