Malignant solid tumor patients
Conditions
Interventions
Test group:Phase Ia:
Administer once on the first day of the single administration period (C0D1-C0D3) and stop for 2 days
If no DLT event occurs, enter the first cycle of multiple dosing periods (C1D1-C1D28), with one dose per day, 28 days per cycle, for a total of 28 days
If no DLT occurs, continue administration until the subject experiences disease progression, withdrawal, or intolerance. The dosage for each administration is determined by the dosage group of the sub
Sponsors
Shandong First Medical University Affiliated Cancer Hospital/Shandong Cancer Prevention and Treatment Research Institute/Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 75 years old, regardless of gender. 2. Meet the following standards: Stage Ia: Patients with advanced malignant solid tumors who have been confirmed by histology or cytology, have failed previous standard treatment regimens, are unable to tolerate or refuse existing therapies. According to the RECIST 1.1 standard, there is at least one evaluable lesion. Phase Ib: Malignant solid tumors confirmed by histology or cytology, with indications for radiation therapy, and an estimated radiation therapy time greater than 4 weeks. According to RECIST 1.1 standard, there is at least one measurable lesion and at least one suitable lesion for puncture. 3. Expected survival time = 3 months. 4. ECOG score 0-1 points. 5. Adequate organ and bone marrow function. 6. Women and men with fertility must agree to use appropriate contraceptive methods (hormone or barrier methods or abstinence) during the study period and within 3 months after the last dose; Female subjects of childbearing age must have a negative blood pregnancy test within 7 days before administration. 7. Understand and be willing to sign a written informed consent form, and be able to follow the research protocol for treatment, visits, and other research procedures.
Exclusion criteria
Exclusion criteria: 1. Patients who have received treatment with DNA-PK inhibitors. 2. Within 4 weeks or 5 half-lives (whichever is longer) prior to the first administration of research treatment, patients have received systemic chemotherapy, traditional Chinese medicine with anti-tumor indications, or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, or biological therapy), or continue to receive these drug treatments during the study period. Except for the following three situations: ·Accept nitrosourea or mitomycin C at least 6 weeks before the last medication. ·Receive extensive radiation therapy (>30% bone marrow radiation therapy), which should be at least 8 weeks after the last radiation therapy. ·Having undergone palliative radiotherapy for bone metastases, it is necessary to wait at least 2 weeks from the last radiotherapy. 3. Patients who underwent major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first administration of the study treatment, and who were scheduled to undergo surgery during the study period. 4. Brain metastasis; Presence of meningeal or brainstem metastasis; Subjects with spinal cord compression. 5. Patients with other malignant tumors within the past 5 years are excluded, except for those who have undergone curative treatment and have not experienced disease recurrence within 5 years after treatment for basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or other carcinoma in situ. 6. Those who have not recovered to CTCAE (V5.0) level 1 or below in terms of previous anti-tumor treatment toxicity, excluding CTCAE (V5.0) level 2 peripheral neurotoxicity and any level of hair loss. 7. Other serious or uncontrolled diseases evaluated by researchers. 8. Subjects with cardiac dysfunction. 9. Pregnant (pre medication pregnancy test positive) or lactating subjects. 10. Subjects with a previous history of severe allergies (such as allergic shock), or patients with allergies to investigational drug related excipients or other components. 11. Researchers believe that there are other factors that are not suitable for participating in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics;Pharmacodynamics;Biomarker; | — |
Countries
China
Contacts
Public ContactYu Jinming/Sun Yuping
Shandong First Medical University Affiliated Cancer Hospital/Shandong Cancer Prevention and Treatment Research Institute/Shandong Cancer Hospital
Outcome results
None listed