Advanced/Metastatic Solid TumorsPhase 1NCT07480681
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 1 study testing HLX97 and Fulvestrant in people with Advanced/Metastatic Solid Tumors, run by Shanghai Henlius Biotech.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced/Metastatic Solid Tumors
- What is being tested?
- HLX97 and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Part 1B will enroll subjects with histologically or cytologically confirmed advanced or metastatic HR-positive, HER2-negative breast cancer.
- Part 2 will enroll subjects with histologically or cytologically confirmed advanced or metastatic HR-positive, HER2-negative breast cancer.
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- ECOG performance status of 0-1;
- Life expectancy ≥ 12 weeks;
- Adequate bone marrow and organ function.
Who cannot join
- 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).
- Presence of spinal cord compression or clinically symptomatic central nervous system (CNS) metastases, defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants to control symptoms. Subjects with stable brain metastases may be included. Subjects with previously diagnosed brain metastases are eligible if they have completed treatment, have recovered from the acute effects of radiotherapy or surgery prior to enrollment, have discontinued corticosteroid therapy for these metastases for at least 3 weeks, and are neurologically stable for 2 months (requiring MRI confirmation).
- 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).
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- Note: Subjects with chronic, stable Grade 2 toxicity deemed by the investigator to be related to prior anti-tumor therapy (defined as no worsening to ≥ Grade 2 for at least 3 months prior to enrollment and managed with standard medical measures) may be enrolled; for example: chemotherapy-induced neuropathy, fatigue, and residual toxicity from prior immunotherapy (Grade 1 or 2 endocrinopathies, which may include hypothyroidism/hyperthyroidism, Type 1 diabetes mellitus, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation/vitiligo).
- Prior radiotherapy to bone marrow involving >25% of the total bone marrow volume (e.g., prior whole pelvic radiotherapy, whole spine radiotherapy, etc.; excluding local radiotherapy to single or a few vertebral bodies, local radiotherapy to the chest wall, etc.).
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (defined as requiring drainage at least once monthly).
- Use of therapeutic anticoagulants. Low molecular weight heparin is permitted. Use of vitamin K antagonists or Factor Xa inhibitors may be permitted after discussion with the sponsor.
- Active inflammatory gastrointestinal disease, refractory or unresolved chronic diarrhea, or history of gastrectomy, gastric banding surgery, or other gastrointestinal conditions or surgeries that could significantly alter the absorption of HLX97 tablets. Treated gastroesophageal reflux disease is permitted.
- Patients who received systemic corticosteroids (prednisone ≥10 mg/day or equivalent dose of similar medication) or other immunosuppressive agents within 14 days prior to the first dose.
- etc
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Advanced/Metastatic Solid Tumors
- Being tested
- HLX97, Fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX97Drug
HLX 97 will be taken as an oral medication.
FulvestrantDrug
Fulvestrant will be taken as an intramuscular medication.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation（Single） | Experimental | A total of 5 dose escalations were preset: Dose1, Dose2, Dose3, Dose4, Dose5 Receives: Drug: HLX97 |
| Dose Escalation（in combination with Fulv） | Experimental | A total of 3 dose escalations were preset: Dose1, Dose2, Dose3 Receives: Drug: HLX97; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 28 days after the first administration of HLX97.
Measured: From first dose to the end of Cycle 1 (each cycle is 4 weeks)
MTD
the highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX97
Measured: From first dose to the end of Cycle 1 (each cycle is 4 weeks)
ORR
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
Measured: approximately up to 24 months
PFS
The PFS is defined as the time from the date of enrollment to the date of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause,whichever occurred first.
Measured: approximately up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480681
- Sponsor's protocol ID
- HLX97-FIH101
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07480681
- Acronym / sponsor ID
- HLX97-FIH101
- Conditions
- Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation（Single） | Experimental | Drug: HLX97A total of 5 dose escalations were preset: Dose1, Dose2, Dose3, Dose4, Dose5 |
| Dose Escalation（in combination with Fulv） | Experimental | Drug: HLX97, Drug: FulvestrantA total of 3 dose escalations were preset: Dose1, Dose2, Dose3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- ECOG performance status of 0-1;
- Life expectancy ≥ 12 weeks;
Key exclusion criteria (13 listed)
- 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).
- Presence of spinal cord compression or clinically symptomatic central nervous system (CNS) metastases, defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants to control symptoms. Subjects with stable brain metastases may be included. Subjects with previously diagnosed brain metastases are eligible if they have completed treatment, have recovered from the acute effects of radiotherapy or surgery prior to enrollment, have discontinued corticosteroid therapy for these metastases for at least 3 weeks, and are neurologically stable for 2 months (requiring MRI confirmation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX97HLX 97 will be taken as an oral medication. | Drug | Dose Escalation（Single）, Dose Escalation（in combination with Fulv） |
| FulvestrantFulvestrant will be taken as an intramuscular medication. | Drug | Dose Escalation（in combination with Fulv） |
Primary outcome
DLT
Time frame: From first dose to the end of Cycle 1 (each cycle is 4 weeks)
DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 28 days after the first administration of HLX97.
MTD
Time frame: From first dose to the end of Cycle 1 (each cycle is 4 weeks)
the highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX97
ORR
Time frame: approximately up to 24 months
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
PFS
Time frame: approximately up to 24 months.
The PFS is defined as the time from the date of enrollment to the date of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause,whichever occurred first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX97 and Fulvestrant in people with Advanced/Metastatic Solid Tumors, run by Shanghai Henlius Biotech.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhixin Yu (021-22200000, zhixin_yu@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: From first dose to the end of Cycle 1 (each cycle is 4 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.