NSCLC
Conditions
Interventions
Group 1:ONC-392 0.1 mg/kg
Group 2:ONC-392 0.3 mg/kg
Group 3:ONC-392 1 mg/kg
Group 4:ONC-392 3 mg/kg
Group 5:ONC-392 10 mg/kg
Group 6:ONC-392 RP2D
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient signed the informed consent in person and voluntarily agreed to participate; 2. The patient is male or female and >= 18 years old at the time of signing the informed consent; 3. The patient must meet the histological or cytological diagnostic criteria for NSCLC or any other type of cancer or sarcoma, progressive metastatic disease, or progressive locally advanced disease for which no local treatment is available; 4. According to the ECOG score standard table, the patient must have a physical condition <= 2; 5. The patient must have adequate organ function; 6. The serum pregnancy test of female patients with fertility potential must be negative to qualify; 7. Women who were pre-menopausal or had been postmenopausal for no more than 5 years, after hysterectomy/oophorectomy or surgical birth control to participate in the study must be willing to use 2 appropriate contraceptive methods to prevent pregnancy or avoid heterosexual activity from 1 visit to 6 months after the last administration of the drug.Approved contraceptive methods include: intrauterine devices, diaphragm containing spermicide, cervical cap containing spermicide, male condom or female condom containing spermicide.Spermicide alone is not an acceptable method of contraception; 8. Male patients must agree to use an appropriate contraceptive method from the first dose to six months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Patients who received chemotherapy, radiation, or biologic cancer therapy within 4 weeks prior to the first dose of study treatment, or who did not recover to CTCAE level 1 or better due to adverse events (other than hair loss or peripheral neurotoxicity) due to cancer treatment 4 weeks prior. 2. Within 30 days before receiving ONC392 treatment, patients participated in clinical trials of other new drugs or used medical devices under clinical development. 3. Patients expect to receive any other form of antitumor therapy during the study period. 4. the patient is receiving chronic systemic steroid therapy, > 10 mg/day, or any other form of immunosuppressive drug. 5. The patient received warfarin chronic anticoagulant therapy. 6. Had other known malignancies in the past 2 years. Note: Subjects with basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast cancer, cervical cancer in situ) who have received potentially curative treatment cannot be excluded. 7. Patients with active Central nervous system (CNS) metastasis and/or cancerous meningitis are known.Patients with previously treated brain metastases may participate, provided they have been clinically stable for at least 1 month prior to the start of the study, as defined by :(1) no evidence of new or expanded brain metastases and (2) steroid withdrawal, or a stable dose of steroids for at least 1 month. 8. Patients with active pneumonia and active colitis (including but not limited to Crohn's disease). 9. The patient previously had severe hypersensitivity to other monoclonal antibody drugs. 10. The patient has any active autoimmune disease or a documented history of autoimmune disease other than vitiligo or cured childhood asthma/atopic disease. 11. The patient had previously received anti-CTLA-4 antibody therapy. 12. Patients who had an active infection requiring treatment or who had received continuous antibiotic treatment for > for 14 days prior to onc-392. 13. Number of copies /ml of hbv-dna > 500 copies /ml in a known patient who is positive for Human Immunodeficiency Virus (HIV) or hepatitis c Virus, or hepatitis b after antiviral treatment. 14. The patient has a known mental illness or substance abuse condition that would prevent them from cooperating with the trial. 15. At the time of signing the informed consent, the patient had a history of substance abuse (including alcohol abuse) within the past 1 year. 16. Patients with uncontrolled ascites or pleural effusion.However, patients with stable clinical status after treatment (including therapeutic pleural puncture or abdominal puncture) are eligible. 17. The patient is pregnant or breastfeeding, or expects to become pregnant or have a child during the estimated study period. 18. In the investigator's judgment, the patient has prior or current evidence of any disease, treatment, or laboratory test abnormality that may confound the results of the study or affect the patient's participation in the study as a whole, or participation in the study is not in the patient's best interest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs/weight;physical examination;ECG;Laboratory examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK;ADA;; | — |
Countries
China
Contacts
Public ContactXianfeng Fang
OncoImmune-Guangzhou,Inc.
Outcome results
None listed