Hepatocellular carcinoma, esophageal cancer, gastric cancer, and anal carcinoma
Conditions
Interventions
Hepatocellular carcinoma subjects:ONC-392 initial dose 10mg/kg, Q3W x2 times, followed by 6mg/kg, Q3W
Subjects with esophageal, gastric and anal cancer:ONC-392 initial dose 10mg/kg, Q3W x2 times, followed by 6mg/kg, Q3W
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the written informed consent. 2. Age = 18 years old when signing the informed consent form. 3. Male or female. 4. ECOG score 0 or 1. 5. Histologically or cytologically confirmed, locally advanced or metastatic HCC, EC, GC (including EGC), and AC that have failed first-line systemic therapy or are intolerant to first-line or more standard therapies. 6. At least one measurable lesion meeting the definition of RECIST 1.1. 7. Adequatet organ function. 8. HCC subjects with Child-Pugh score = 7. 9. Contraception from the first dose to 6 months after the last dose. 10. Estimated survival period = 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Subjects who have not recovered from AEs caused by previous anti-tumor therapy to Grade = 1 as defined by NCI-CTCAEv5.0. 2. Failure to meet the washout period for prior antineoplastic therapy prior to first treatment. 3. Major surgery within 4 weeks before the first treatment. 4. The subject expects any other form of anti-tumor treatment during the study period. 5. Receiving chronic systemic corticosteroid therapy. 6. Accepting warfarin chronic anticoagulant therapy at present and during the study period. 7. Subjects who have had CTCAE 5.0 = grade 3 infusion reactions to monoclonal antibodies. 8. Immune-related adverse events (irAE) of grade = 3 occurred in previous immunotherapy or led to the termination of immunotherapy. 9. The subject has known active central nervous system metastasis. 10. Have major cardiovascular and cerebrovascular diseases. 11. Clinically significant bleeding symptoms or definite bleeding tendency within 6 months prior to the first dose. 12. Active colitis. History or presence of gastrointestinal perforation and/or fistula, active gastric/duodenal ulcer (EC and GC subjects are excluded), intestinal obstruction, diverticulitis within 6 months prior to the first dose. 14. History of allogeneic organ transplantation or hematopoietic stem cell transplantation, or plans to receive organ, or bone marrow transplantation during the study. 15. Vaccination within 1 month before the first dose, or planned vaccination during the study period. 16. Other malignant tumors that have not been cured within 5 years before the first administration, except for early malignant tumors that have been completely cured. 17. Pregnant or lactating women. 18. Other situations where the investigator believes that the subject is not suitable for participating in clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate, ORR;DoR, BoR, DCR, mPFS, PFS3, PFS6;mOS, OS6, OS12;Pharmacokinetics;Anti-drug antibody; | — |
Countries
China
Contacts
Public ContactRuihua Xu
Sun Yat-sen University Cancer Center
Outcome results
None listed