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Trial Title:
A Phase I Study of Hemay181 in Patients With Advanced Solid Tumors
NCT ID:
NCT05749432
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hemay181
Description:
Hemay181 will be given intravenously on the first day per cycle, and the treatment cycle
is 21-days.
Arm group label:
Hemay181
Summary:
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.
Detailed description:
The primary purpose of this study is to evaluate the safety and tolerability of Hemay181
in patients with advanced solid tumors, and to explore the maximum tolerated dose. The
secondary purpose is to evaluate the pharmacokinetic profile of Hemay181 in patients with
advanced solid tumors and to evaluate the preliminary evaluation of the anti-tumor
efficacy of Hemay181.
The study will be conducted in two parts. Part one, trial will be conducted in about 24
subjects to determine safety and tolerability of Hemay181 in patients with advanced solid
tumors. Part two, approximately 15-27 additional subjects with advanced solid tumors are
included to better define the tolerability and preliminary efficacy of Hemay181.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female subjects aged 18 to 65 years;
2. Subjects must give informed consent to the study before the study entry and
voluntarily sign a written informed consent form;
3. 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;
4. 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;
5. At least 4 weeks after the latest treatment (chemotherapy, targeted therapy,
immunotherapy, radiotherapy, and/or major surgery, etc.), at least 2 weeks after
endocrine therapy, and have recovered from the toxic effects caused by previous
treatment to lower than grade 1 (CTCAE version 5.0) [patients with hair loss (any
grade), pigmentation (any grade), peripheral sensory neuropathy (grade ≤2) can be
enrolled];
6. Eastern Cooperative Oncology Group(ECOG) score of 0,1；
7. Life expectancy of at least three months;
8. Adequate bone marrow, liver, kidney function, meeting the following criteria:
ANC≥1.5×10^9/L, HB≥90g/L, PLT≥75×10^9/L; ALT≤2.5×ULN, AST≤2.5×ULN with no liver
metastasis, or ALT≤5×ULN, AST≤5×ULN with liver metastasis; TBIL≤1.5×ULN; Serum
creatinine ≤1.5×ULN；
9. All female and male subjects must agree and commit to the use of a reliable
contraceptive regimen for the duration of the study and for at least 12 weeks after
at the last dose of test article.
Exclusion Criteria:
1. Pregnant or lactating women;
2. Patients with known central nervous system metastatic disease;
3. 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;
4. Patients with active infection requiring intravenous anti-infective therapy;
5. Patients with a history of irinotecan allergic reactions or previous irinotecan
gastrointestinal toxicity ≥ grade 3;
6. Have received drug therapy from other clinical trials within 4 weeks prior to
enrollment;
7. Known allergy to the active ingredient or excipients of the test drug;
8. The investigator believes that the subject has any clinical or laboratory
abnormalities and is not suitable to participate in this clinical study.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Huiping Li
Phone:
13811012595
Email:
huipingli2012@hotmail.com
Start date:
March 20, 2023
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Ganzhou Hemay Pharmaceutical Co., Ltd
Agency class:
Industry
Source:
Ganzhou Hemay Pharmaceutical Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05749432
