A Study of HDM2006 in Patients With Advanced Solid Tumor
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
About this trial
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2006 in patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. The subjects understand and voluntarily (or legally authorized guardian) sign a written informed consent form (ICF) approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Disqualifiers
1. Subjects who are concurrently participating in another clinical study, unless it is an observational (non-interventional) clinical study or they are in the survival follow-up period of an interventional study.
Subjects who have received major surgery within 4 weeks prior to the first dose, excluding minor surgery, such as appendicitis surgery, tissue acquisition for tumor biopsy, etc.;
Subjects who have received bone marrow (equivalent to pelvic bone marrow area) or extensive radiotherapy within 28 days prior to the first dose; subjects who have received local radiotherapy (e.g., thoracic and rib radiotherapy) within 7 days prior to the first dose of the study drug;
Subjects who have previously received HPK1 inhibitor treatment. 3. Subjects who have history of active malignancies within the past 2 years, with the exception of tumors in this study and cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, cervix carcinoma in situ, breast cancer in situ, etc.
Trial design
Design model
Sequential
Treatments tested in this trial
HDM2006
DrugOral administration within half an hour after a meal, QD
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: HDM2006Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase)
DLT will be determined by definition during the DLT observation period.
Time frame
up to 21 days following first dose2
Incidence and severity of adverse events(for dose escalation phase)
The safety profile of HDM2006 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame
Until 30 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first3
Change from baseline in HPK1 expression in tumor tissues (dose expansion)
HPK1 expression levels will be measured using Flow Cytometry. The unit of measure is percentage of positive cells.
Time frame
through study completion, an average of 1 year4
Changes from baseline in pSLP-76 expression in tumor tissue (dose expansion)
pSLP-76 expression levels will be measured using Flow Cytometry. The unit of measure is percentage of positive cells.
Time frame
From baseline through study completion, an average of 1 yearSecondary outcomes
1
Plasma concentration of HDM2006
Plasma concentration of HDM2006
Time frame
up to7 days following last dose2
Objective Response Rate (ORR)(for dose escalation phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Time frame
through study completion, an average of 1 year3
Time to Response (TTR)
TTR is defined as the interval from the start of study therapy to the first documentation of an objective response.
Time frame
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months4
Progression free survival (PFS)
PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause.
Time frame
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsSponsors and contacts
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Source ClinicalTrials.gov