Evaluating Hemay181 for advanced solid tumors

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Antitumor Efficacy of Hemay181 in Patients With Advanced Solid Tumors

This study is testing a new treatment called Hemay181 to see if it is safe and effective for people with advanced solid tumors that haven't improved with standard treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05749432 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, and pharmacokinetic profile of Hemay181 in patients with advanced solid tumors. It will involve approximately 51 participants, divided into two parts: the first part will focus on determining the maximum tolerated dose, while the second part will further evaluate tolerability and preliminary anti-tumor efficacy. Participants must have advanced solid tumors that have not responded to standard therapies. The study will utilize imaging techniques to evaluate measurable lesions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with advanced solid tumors that have failed at least two lines of standard therapy.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard treatment options.

How similar studies have performed: While this approach is being explored, similar studies have shown promise in evaluating new treatments for advanced solid tumors.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Huiping Li

Conditions: Solid Tumor