A Phase I Study of Hemay181 in Patients With Advanced Solid Tumors

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGanzhou Hemay Pharmaceutical Co., Ltd

About this trial

The study will be conducted in about 51 participants in total. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor efficacy of Hemay181 in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects aged 18 to 65 years;

Subjects must give informed consent to the study before the study entry and voluntarily sign a written informed consent form;

Advanced solid tumors patients that confirmed by pathology (histology or cytology) with adequate standard therapy failure or currently have no effective standard treatment (such as breast, liver, lung, gastric cancer, colorectal cancer, etc.); Standard therapy failure is defined as: patients who have undergone at least 2 lines of standard antineoplastic therapy after recurrence/metastasis (including treatment-naïve stage IV) (if only 1-line therapy is recommended for the tumor, standard 1-line therapy shall prevail), and who have been confirmed by the investigator or have a clear disease progression or are intolerable by the medical history;

At least one lesion that can be evaluated by CT/MRI (measurable lesions are required) and meet the reproducible evaluation requirements in RECIST V1.1;

Disqualifiers

Pregnant or lactating women;

Patients with known central nervous system metastatic disease;

Positive blood for human immunodeficiency virus (HIV antibody); Positive hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (HBV-DNA)>upper limit of normal; Active hepatitis C virus (HCV) infection;

Patients with active infection requiring intravenous anti-infective therapy;

Trial design

Design model

Single group

Treatments tested in this trial

  • Hemay181

    Drug

    Hemay181 will be given intravenously on the first day per cycle, and the treatment cycle is 21-days.

Treatment groups

51 Participants
are divided into 1 treatment group
Group A: Hemay181Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events

Time frame
3 weeks of treatment
2

Incidence of dose-limiting toxicity (DLT) in each dose group

Time frame
3 weeks of treatment
3

Maximum tolerated dose (MTD) or Maximum climbing dose (MAD) of Hemay181

Time frame
3 weeks of treatment
4

Subsequent recommended doses of Hemay181

Time frame
3 weeks of treatment

Secondary outcomes

1

Objective Response Rate

Time frame
3 weeks of treatment
2

Duration of Response

Time frame
3 weeks of treatment
3

Disease Control Rate

Time frame
3 weeks of treatment
4

Time to Response

Time frame
3 weeks of treatment

Other outcomes

Sponsors and contacts

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