A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Henlius Biotech
About this trial
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX37 in patients with advanced/metastatic solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Before the trial, fully understand the content, process and possible adverse reactions of the trial, sign the informed consent form, voluntarily participate in the trial, and be able to complete the research in accordance with the requirements of the trial protocol.
At the time of signing the ICF, the applicant must be at least 18 years old and no more than 75 years old, with no gender restrictions.
part 1 of Stage Ia enrolled subjects with advanced or metastatic solid tumors confirmed by histology or cytology, who had failed at least one standard systemic treatment in the advanced or metastatic stage of the disease (subjects who had received neoadjuvant or adjuvant therapy, if disease progression or recurrence occurred within 6 months after the end of treatment) Then this treatment plan will be regarded as a failure of standard treatment, or there is currently no effective standard treatment method.
Within 4 weeks before the first administration, at least one measurable lesion was present according to the efficacy evaluation criteria of RECIST 1.1. For patients who have received radiotherapy before, if the lesion can be measured according to RECIST v1.1 and there is objective evidence proving significant progression after radiotherapy, the lesion that has undergone radiotherapy can be regarded as the target lesion. Brain metastases cannot be used as target lesions.
Disqualifiers
There should be a history of other malignant tumors within 3 years prior to the first medication, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin.
There have been adverse events in the past that led to the permanent termination of immunotherapy; Or there was a history of grade ≥2 immune-related pneumonia or immune-related myocarditis;
Has a history of (non-infectious) interstitial lung disease (ILD), and currently still requires steroid drug treatment; Or currently having active ILD, or suspected through imaging researchers at the time of screening that there is a risk of ILD aggravation or that they are not suitable to participate in this study;
It is known that the subject has had a severe allergic reaction to macromolecular protein preparations/monoclonal antibodies in the past, or is allergic to the components of the test drug preparation;
Trial design
Design model
Single group
Treatments tested in this trial
HLX37
DrugHLX37 will be administered as an intravenous (IV) infusion.
Treatment groups
254 Participants
are divided into 2 treatment groupsGroup A: Phase Ia：Dose EscalationExperimental treatment 1 intervention
Group B: Phase Ib：Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The Dose-Limiting Toxicity (DLT) of HLX37 within 21 days after the first Administration
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 21 days after the first administration of HLX37.
Time frame
From first dose to the end of Cycle 1 (each cycle is 3 weeks)2
2. The maximum tolerated dose (MTD) of HLX37
The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX37
Time frame
From first dose to the end of Cycle 1 (each cycle is 3 weeks)Secondary outcomes
1
Objective response rate (ORR)
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
Time frame
approximately up to 24 months2
Duration of response (DOR)
Length of time response continued based on investigator's assessment.
Time frame
approximately up to 24 months.3
Progression-free survival (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.4
Overall survival (OS)
Time from the date of enrollment to the date of death for any cause.
Time frame
approximately up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov