Advanced Solid Tumor
Conditions
Brief summary
To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B208 in the trial participants of unresectable advanced or metastatic solid tumors
Interventions
DRUGICP-B208
ICP-B208 will be administered by intravenous infusion every 3 weeks (Q3W) until disease progression (PD) or the occurrence of unacceptable toxicity or withdrawal from the study for other reasons (whichever occurs first).
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 years old to 75 years old; 2. Unresectable locally advanced or metastatic gastrointestinal tumors or other advanced solid tumors that have failed previous systemic treatment and have been confirmed by histopathology or cytology; 3. The ECOG physical fitness score is 0 to 1 point. 4. There is at least one measurable lesion; 5. The organ function level must meet the prescribed standards; 6. Effective contraceptive measures should be taken from the date of signing the informed consent form until at least 6 months after the use of the last dose of the study drug. 7. Voluntarily enroll in the group and sign the informed consent form, and follow the trial treatment protocol and visit plan.
Exclusion criteria
1. Other active malignant tumors occurred within 3 years before the first administration of the study drug; 2. Received the anti-tumor treatment defined by the protocol within the time range before the first administration of the study drug specified in the protocol; 3. Trial participants with unstable primary CNS tumors or CNS metastases; 4. Uncontrollable or significant major cardiovascular diseases; 5. Severe or uncontrollable systemic diseases; Or any unstable systemic disease; 6. Active infection as defined in the plan; 7. Have a history of severe allergic reactions to active pharmaceutical ingredients, non-active components in drugs or antibody drugs; 8. Those who are known to have a history of alcohol abuse or drug abuse; 9. Other circumstances that the researcher deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The types, severity, correlation with the investigational drug and incidence of adverse events and serious adverse events | 2 years |
| The types, severity and incidence of dose-limiting toxicity (DLT) | 1 year |
| The Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD) | 1 year |
| Objective response rate (ORR) by researchers | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) | 1 year |
| Time to Maximum Plasma Concentration (Tmax) | 1 year |
| Half-life (T1/2) | 1 year |
| Area under the concentration-time curve from zero time to infinity (AUC0-∞) | 1 year |
| Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t) | 1 year |
| Apparent Clearance(CL/F) | 1 year |
| Terminal Apparent Volume of Distribution (Vz/F) | 1 year |
| The ORR evaluated by the researchers | 2 years |
| The Disease Control Rate (DCR) evaluated by the researchers | 2 years |
| The Duration of Response (DOR) evaluated by the researchers | 2 years |
| The Progression-Free Survival (PFS) evaluated by the researchers | 2 years |
| The Radiographic Progression-Free Survival (rPFS) evaluated by the researchers | 2 years |
| The Overall Survival (OS) evaluated by the researchers | 2 years |
| Number of participants with anti-drug antibodies (ADA) to ICP-B208 | 1 year |
Countries
China
Contacts
CONTACTAixia Lu
Outcome results
None listed