Oncology
Conditions
Interventions
Part A: AI-081 Group 1:Intravenous infusion of AI-081 Injection at a dose level of 1 mg/kg, once every 3 weeks
Part A: AI-081 Group 2:Intravenous infusion of AI-081 Injection at a dose level of 3 mg/kg, once every 3 weeks
Part A: AI-081 Group 3:Intravenous infusion of AI-081 Injection at a dose level of 10 mg/kg, once every 3 weeks
Part A: AI-081 Group 4:Intravenous infusion of AI-081 Injection at a dose level of 20 mg/kg, once every 3 weeks
Part BI: AI-081 Group B1:Intravenous infusion of AI-081 Injection at a dose level of 3 mg/kg, once every 3 weeks
Part BI: AI-081 Group B2:Intravenous infusion of AI-081 Injection at a dose level of 10 mg/kg, once every 3 weeks
Part BI: AI-081 Group B3:Intravenous infusion of AI-081 Injection at a dose level of 20 mg/kg, once every 3 weeks
Part BII: AI-081 Group 1:Intravenous infusion of AI-081 Injection at a dose level of RP2D1 (the lower dose among the appropriate doses for each indication), once every 3 weeks
Part BII: AI-081 Group 2:Intravenous infusion of AI-081 Injection at a dose level of RP2D2 (the higher dose among the appropriate doses for each indication.), once every 3 weeks
Part BII: AI-081 Group E:Intravenous infusion of AI-081 Injection at a dose level of RP2D (Recommended Phase II Dose), once every 3 weeks
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria for Part A: 1. Participants aged >=18 years on the day of signing the informed consent form. 2. Male or female participants are eligible. Female participants of childbearing potential must have a negative pregnancy test. 3. Eastern Cooperative Oncology Group (ECOG) performance status =1 and a life expectancy of >=12 weeks. 4. Participants with advanced or metastatic solid tumors that have been histologically or cytologically confirmed and have progressed after standard therapy, are intolerant to standard therapy, are unlikely to benefit from standard therapy, have no access to standard therapy, or refuse standard therapy. 5. At least one measurable lesion according to RECIST version 1.1. 6. Adequate organ function. 7. Voluntary agreement to participate in the study by signing the written informed consent form. 8. Participants must agree to use effective contraception from the first administration of the study drug until 120 days after the last dose of study treatment. Inclusion criteria for Part B: 1. Participants aged >=18 years on the day of signing the informed consent form. 2. Male or female participants are eligible. Female participants of childbearing potential must have a negative pregnancy test. 3. Eastern Cooperative Oncology Group (ECOG) performance status =1 and a life expectancy of >=12 weeks. 4. (1) Histologically confirmed unresectable or metastatic colorectal cancer with disease progression after first- or second-line systemic therapy, or intolerance due to toxicity with refusal of other standard therapy or lack of access to other standard therapy; microsatellite stable (MSS) status. (2) Histologically or cytologically confirmed locally advanced or metastatic non–small cell lung cancer with positive tumor PD-L1 expression and negative targetable driver gene alterations. (3) Histologically or cytologically confirmed small cell lung cancer with extensive-stage disease, with progression or recurrence after first- or second-line systemic therapy, or intolerance due to toxicity with refusal of other standard therapy or lack of access to other standard therapy. (4) Pathologically confirmed advanced or metastatic high-grade epithelial ovarian cancer with disease progression or recurrence after at least one line of systemic therapy, or intolerance due to toxicity with refusal of other standard therapy or lack of access to other standard therapy; prior disease progression or recurrence after platinum-based therapy. (5) Histologically confirmed advanced or metastatic cutaneous or visceral angiosarcoma that is not amenable to curative treatment or where curative treatment is refused; taxane-resistant disease. 5. At least one measurable lesion according to RECIST version 1.1. 6. Adequate organ function. 7. Voluntary agreement to participate in the study by signing the written informed consent form. 8. Participants must agree to use effective contraception from the first administration of the study drug until 120 days after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: Exclusion criteria for both Part A and Part B: 1. Adverse events (AEs) related to prior antitumor therapy that have not recovered to 10 mg/day prednisone or equivalent within 7 days prior to the first dose. 4. Presence of active or symptomatic brain metastases, or a history of leptomeningeal metastasis. 5. History of another malignancy requiring systemic treatment within 24 months prior to C1D1, other than the tumor being treated in this study. 6. History of >= Grade 3 allergic reactions or hypersensitivity reactions to intravenous infusion drugs. 7. Tumor encasement of major blood vessels, or presence of obvious necrosis, cavitation, or bleeding, or invasion of surrounding major organs and vessels; or requirement for oral anticoagulant therapy; or clinically significant bleeding within 6 months prior to the first dose or a known bleeding tendency; or melena, hematemesis, or hemoptysis within 1 month prior to the first dose; or participants considered by the investigator to be at risk of visceral bleeding; or any other condition considered by the investigator to pose a high risk of fatal bleeding. 8. History of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose. 9. Moderate or large pleural effusion, pericardial effusion, or ascites requiring drainage every two weeks or more frequently within 4 weeks prior to the first dose. 10. History of major cardiovascular events or severe immune-related adverse events within 6 months prior to the first dose. 11. Active infection requiring systemic intravenous antimicrobial therapy within 14 days prior to C1D1, or active infection requiring oral antimicrobial therapy within 7 days prior to C1D1. 12. Evidence of active interstitial lung disease (ILD) or noninfectious pneumonitis within 28 days prior to C1D1. 13. Any condition that, in the opinion of the investigator, would make participation in the study not in the best interest of the participant. 14. Participants who are pregnant or breastfeeding, or who plan to become pregnant or father a child during the study or within 120 days after the last dose of the study drug. 15. Uncontrolled hypertension. 16. QTcF >470 ms on electrocardiogram during the screening period. 17. Known HIV antibody positivity; or HCV RNA positivity; or chronic HCV infection without completion of curative anti-HCV therapy at least 4 weeks prior to the first dose; or HBsAg positivity and/or elevated HBV DNA with refusal to initiate anti-HBV therapy at least one week before the first dose of the study drug; or active tuberculosis; or other active infectious diseases that are difficult to control. 18. The washout period for prior antitumor therapy such as chemotherapy, targeted therapy, or radiotherapy is 14 days. The washout period for antitumor antibody-based therapies is 28 days. The washout period for proprietary Chinese medicines with approved antitumor indications (excluding herbal decoctions) is 7 days. For palliative radiotherapy to painful metastatic lesions or lesions at potentially sensitive sites (e.g., epidural space), the washout period is at least 7 days prior to the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D);Part A: Incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs).;Part B: Objective response rate (ORR).;Part B: Incidence of TEAEs and TRAEs, and the study treatment discontinuation rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A and Part B: Pharmacokinetics.;Part A and Part B: Anti-drug antibodies (ADA);Part A and Part B: Objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and best overall response (BoR).;Part A and Part B: Progression-free survival (PFS).;Part A and Part B: Overall survival (OS).; | — |
Countries
China
Contacts
Public ContactYilong Wu
Guangdong Provincial People's Hospital
Outcome results
None listed