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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

ConditionAdvanced/Metastatic Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Henlius Biotech

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • HLX97

    Drug

    HLX 97 will be taken as an oral medication.

  • Fulvestrant

    Drug

    Fulvestrant will be taken as an intramuscular medication.

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Dose Escalation（Single）Experimental treatment 1 intervention
Group B: Dose Escalation（in combination with Fulv）Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From first dose to the end of Cycle 1 (each cycle is 4 weeks)
2

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

Time frame
From first dose to the end of Cycle 1 (each cycle is 4 weeks)
3

ORR

Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.

Time frame
approximately up to 24 months
4

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.

Time frame
approximately up to 24 months.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: