Advanced Solid Tumors
Conditions
Brief summary
An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients with Advanced Solid Tumors
Interventions
DRUGICP-B794
Intravenous administration once every 3 weeks
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years and ≤75 years. 2. Histologically confirmed other locally advanced or metastatic solid tumors. 3. Life expectancy ≥3 months. 4. Adequate organs function within 7 days prior to the first dose of ICP-B794 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1。 6. At least one measurable lesion per RECIST V1.1 criteria. 7. Able to provide archived tumor tissue sample (within 2 years) or fresh tumor tissue sample. 8. Female participants of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening. 9. WOCBP and male participants must agree to use contraceptive method. 10. Female participants must not breastfeed or plan pregnancy during the study and for at least 6 months after the last dose of investigational drug. 11. Participants must be able to communicate effectively with investigators and comply with all study requirements. 12. Participants voluntarily joined the study and signed the informed concent form (ICF).
Exclusion criteria
1. Other active primary malignancies within 3 years prior to the first dose of investigational product. 2. Prior or current treatment with the similar drug or related treatment specified in the protocol. 3. Having a past medical history and unhealthy lifestyle history as specified in the protocol, or suffering from diseases as specified in the protocol. 4. Toxicities from prior anti-tumor therapy not recovered to ≤ Grade 1 (per CTCAE V5.0). 5. Major arterial or venous thrombotic events within 3 months prior to first dose. 6. Active bleeding within 2 months prior to screening or history of clinically significant bleeding tendency. 7. Major surgery within 28 days prior to first dose or minor surgery within 2 weeks prior to first dose. 8. Requirement for systemic corticosteroid therapy within 14 days prior to first dose. 9. History of severe hypersensitivity, or known severe hypersensitivity to the active pharmaceutical ingredient, inactive ingredients in the drug product, or antibody-based drugs, or hypersensitivity to recombinant human or murine proteins, or history of severe infusion reaction. 10. Administration of any live vaccine within 4 weeks prior to first dose or history of hypersensitivity reactions of any grade. 11. Female participants who are pregnant, lactating, or planning pregnancy during the study. 12. Any psychiatric or cognitive disorder that may impair understanding or execution of the informed consent document and/or protocol compliance 13. Other conditions determined by the investigator that render patients unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to 2 years | — |
| Incidence, character, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0 | Up to 2 years | — |
| Dose-limiting toxicities (DLT) | Up to 2 years | Incidence, character, and severity of dose-limiting toxicities. |
| The Recommended Dose (RD) of ICP-B794 for expansion and Maximum Tolerated Dose (MTD) | Up to 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR) | Up to 2 years |
| Progression-Free Survival (PFS) | Up to 2 years |
| Radiographic progression-free survival (rPFS) | Up to 2 years |
| Overall survival (OS) | Up to 2 years |
| Apparent Clearance (CL/F) | Up to 2 years |
| Maximum Plasma Concentration (Cmax) | Up to 2 years |
| Time to Maximum Plasma Concentration (Tmax) | Up to 2 years |
| Half-life (T1/2) | Up to 2 years |
| Area under the concentration-time curve from zero time to infinity (AUC0-∞) | Up to 2 years |
| Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t) | Up to 2 years |
| Number of participants with anti-drug antibodies (ADA) to ICP-B794 | Up to 2 years |
| Terminal Apparent Volume of Distribution (Vz/F) | Up to 2 years |
| Objective Response Rate (ORR) | Up to 2 years |
| Disease control rate (DCR) | Up to 2 years |
Other
| Measure | Time frame |
|---|---|
| B7-H3 protein expression | Up to 2 years |
Countries
China
Contacts
Primary ContactYilong Wu
Outcome results
None listed