Malignant Neoplasms
Conditions
Brief summary
Phase I study of IMMH-010 in patients with advanced malignant solid tumors
Detailed description
To evaluate the safety and tolerability of single-dose and multi-dose IMMH-010 in patients with advanced solid tumors, et al.
Interventions
DRUGIMMH-010
After tolerance study, 360mg and above IMMH-010 will be administered in Dose expansion study.
Sponsors
Tianjin Chasesun Pharmaceutical Co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects are eligible only if they meet all the following criteria: 1. Age ≥ 18 years when they sign the informed consent form; 2. Patients with advanced or metastatic solid tumors that are confirmed by cytological or histological examination, who did not respond to standard treatment regimens, or did not tolerate these regimens, or had no effective standard treatment regimens, or refused standard treatment regimens; 3. The ECOG score is 0 or 1 point (see the scoring criteria in Appendix 1); 4. Based on RECIST 1.1 (see the scoring criteria in Appendix 4), Subjects in Part B study must have at least one measurable lesion, and subjects in Part A study may have no measurable lesion; Definition of measurable lesion: 1. Tumor lesion: The size must be accurately measurable on two mutually perpendicular diameters, and both diameters must be ≥10 mm or ≥2 times of the slice thickness 2. Lymph node lesion: The size must be accurately measurable on two mutually perpendicular diameters, and both diameters must be ≥15 mm or ≥2 times of the slice thickness 5. In subjects who had received other treatments, the toxic and side effects should return to grade ≤ 1 or to the baseline (NCI-CTCAE 5.0, excluding alopecia); 6. The expected survival time should be at least 3 months; 7. Subjects should have appropriate organ and bone marrow functions, and have laboratory test results within the following ranges before entering the group: Bone marrow reserve (within 14 days, no transfusion of blood or blood products, or no correction by G-CSF or other hematopoietic stimulate factors): absolute neutrophils count (ANC) ≥1.5×109/L; hemoglobin (HB) ≥90 g/L; and platelet (PLT) ≥75×109/L; Liver function: ALT≤2.5×ULN; AST≤2.5×ULN; ALP≤2.5×ULN; TBIL≤1.5×ULN (patients with known Gilbert's disease are eligible if their serum bilirubin level ≤3×ULN; and patients with metastases to liver are eligible if their ALT≤5×ULN, AST≤5×ULN, and ALP≤5×ULN); and albumin ≥3 g/dL; Kidney function: creatinine ≤1.5×ULN or creatinine clearance ≥45 mL/min as calculated according to Cockcroft-Gault formula (refer to Appendix 2); Blood coagulation function: INR, PT, and APTT≤1.5×ULN (in patients not on anticoagulants; and it is decided by investigators whether patients on anticoagulants are eligible); Cardiac enzymes CK and CKMB measures are not exceeding the upper limit of normal value; Thyroid function measures are within the normal range or mildly abnormal but requiring no treatment. 8. Fertile eligible patients (males and females) must give their consent to taking reliable contraceptive measures (hormone, barrier, or sexual abstinence) throughout the trial and at least 4 months after the last dosing; reproductive-age females must have negative blood or urine pregnancy test within 21 days prior to initial dosing; 9. The subjects must give their informed consent for the study and signed ICF voluntarily before the trial; 10. The subjects or the statutory agents should be able to communicate well and complete the study complying with the protocol.
Exclusion criteria
Subjects are excluded if they meet one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | Part A Dose escalation study at the end of Cycle 1 (Cycle1 is 21 days) | To identify the dose-limiting toxicity (DLT) in dose escalation study. |
| Adverse reaction rate | From date of singing informed consent until the 30 days after the last study dose or the start date of a new anti-cancer therapy, whichever came first. | Observe all the participants in any adverse events occurred during the period of clinical research, including clinical symptoms and signs of life, an abnormal in laboratory tests, record its clinical characteristics, severity, occurrence time, duration, treatment and prognosis, and determine its and the correlation between test drugs. NCI-CTCAE 5.0 standard was used to evaluate drug safety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | Part A Dose escalation study: At the end of Cycle1(Cycle1 is 21 days), Part B: At the end of Cycle0(Cycle0 is 4 days). | Time to peak plasma concentration. |
| AUC | Part A Dose escalation study: At the end of Cycle1(Cycle1 is 21 days), Part B: At the end of Cycle0(Cycle0 is 4 days). | Area under the plasma concentration versus time curve. |
| Progression-free survival (PFS) | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years). | PFS is defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1. |
| Duration of response (DOR) | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years). | DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1. |
| Disease control rate (DCR) | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years). | DCR is defined as the percentage of participants who have BOR of CR or PR or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1. |
| Objective response rate (ORR) | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first (up to approximately 2 years). | ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1. |
| Cmax | Part A Dose escalation study: At the end of Cycle1(Cycle1 is 21 days), Part B: At the end of Cycle0(Cycle0 is 4 days). | Peak plasma concentration. |
Countries
China
Outcome results
None listed