Advanced solid tumor
Conditions
Interventions
Dose-escalation group:Divide into 7 groups and treat respectively
Expansion group:Two appropriate dose
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. All subjects or legal representatives must sign an informed consent form approved by the Ethics Committee before any screening procedure starts; 2. Patients with recurrent or/and metastatic advanced solid tumors confirmed by histology or cytology at 18 years old or older; 3. The expansion phase may include hepatocellular carcinoma (HCC), triple-negative and/or inflammatory breast cancer, colorectal cancer, esophageal cancer, gastric cancer, non-small cell lung cancer, head and neck cancer, and/or cancer types that shows efficacy of drug in dose escalation phase; 4. Patients whose situation have no standard treatment or standard treatment failed or is intolerable; 5. According to RECIST 1.1 standard, there is at least one measurable target lesion; 6. Patients with no central nervous system metastasis, or asymptomatic brain metastasis without any treatment intervention, or clinical and radiological stability for least 4 weeks prior to screening. For the latter 2 cases, patients are required to have no long-term use of corticosteroids. And the number of lesions in the brain should be = 2, and the maximum diameter of lesion should be =12 weeks; 9. ECOG (Eastern Tumor Cooperative Group) score of baseline is 0 or 1. For patients with hepatocellular carcinoma, the Child-Pugh liver function should be rated as Class A; 10. Patients meeting the following laboratory examination requirements during screening: (1) Bone marrow reserve (blood transfusion within 14 days prior to screening to meet the requirement is forbidden): Absolute Neutrophil Count (ANC) > 1.5x10^9/L; Platelets >=100 x10^9/L; Hemoglobin >=90 g/L; (2) Renal function: serum creatinine = 60 mL/min, calculated by Cockcroft-Gault formula; (3) Liver function: Total bilirubin =45% and hemodynamic stability as determined by echocardiography or by multi-gated acquisition scan(MUGA); 12. The patient must recover from the previous therapeutic toxicity to <=1 grade, except: (1) hair loss; (2) hyperpigmentation; (3) long-term toxicity caused by radiotherapy which investigator judge as unrecoverable; (4) neurotoxicity of grade 2 and below caused by platinum (CTCAE 5.0); 13. Women of childbearing age and all male subjects must agree to use effective contraceptive methods during the study period and 30 days after discontinuation of study.
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to any active ingredient or excipient of RMX1002 tablets, or to have history of specific allergic reactions (asthma, rheumatism, eczema dermatitis) that the investigator judges to be unsuitable for treatment; 2. Patients who have previously received treatment of EP4 inhibitors; 3. Patients who have been treated with COX-2 drugs and show significant toxicity or intolerance (such as cardiovascular toxicity, nephrotoxicity, allergies, etc.); 4. Patients who have been treated with COX-2 inhibitors or NSAIDs within 14 days prior to drug administration or during the study period (see Appendix 6 for a list of specific drugs) 5. Patients who have received any other study medication within 30 days prior to the first dose of investigational drug; 6. Patients who have been treated with systemic anti-tumor treatment within 28 days prior to the first dose of investigational drug, including chemotherapy, biological immunotherapy, hormone therapy, anti-tumor Chinese medicine treatment (except for bisphosphonates for bone metastasis treatment), or patients who, after receiving a cell treatment, have been confirmed therapeutic cells in their body have disappeared or disease progresses; 7. Patients who currently or previously suffer a second tumor excluding the scope of the study protocol (except for well-treated basal cell carcinoma or squamous cell carcinoma, and cervical carcinoma in situ) unless the second tumor has been radically treated and shows no evidence of recurrence or metastasis within 5 years; 8. Patients who have had abdominal fistula, gastrointestinal perforation or abdominal abscess within 30 days before screening; 9. Patients who have a significant history of gastrointestinal disease or present illness 1 month prior to signing informed consent, such as inability to swallow, uncontrollable nausea and vomiting, chronic diarrhea, and intestinal obstruction, and patients who have active digestive tract ulcers or other chronic gastrointestinal diseases within 12 months prior to signing the informed consent form, are have inability of drug swallowing or difficulty in administration, transportation or absorption of the drug, or have previously performed a bowel resection or Total gastrectomy; 10. Patients who had a previous organ transplants or who are preparing for organ transplantation; 11. Those who have undergone major surgical treatment, incisional biopsy or undergone significant traumatic injury within 4 weeks prior to the first dose of investigational drug (all patient in former cases must fully recover and stabilize before study begins); 12. Female patients during pregnancy or lactation; 13. Any situation of uncontrolled hypertension (>140/90), QTc is abnormal and with clinically significant in ECG examination (corrected QTc > 450 msec [male] or QTc > 470 msec [female] at resting state), unstable coronary artery disease confirmed by uncontrolled arrhythmia, unstable angina pectoris, decompensated congestive heart failure (> New York Heart Association Class II) or myocardial infarction within 6 months prior to investigational drug administration; 14. Any uncontrollable serious problem related with the clinical study (such as drug abuse, uncontrolled psychiatric state or cognitive impairment, uncontrolled pleural effusion and/or pericardial effusion, uncontrolled complications, including active infections, arterial thrombosis, and symptomaticpulmonary embolism; 15. Patients whose tests as below have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index;Efficacy evaluation index; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK/PD evaluation index; | — |
Countries
China
Contacts
Public ContactShen Lin
Beijing Cancer Hospital
Outcome results
None listed