Locally Advanced Solid Tumor
Conditions
Brief summary
This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.
Interventions
DRUGIBI3001
The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study. IBI3001 is proposed to be administered by intravenous infusion (IV)
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female participants ≥ 18 years old; 2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 3. Has an anticipated life expectancy of ≥ 12 weeks; 4. Adequate bone marrow and organ function: 5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion. 6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks. Key
Exclusion criteria
1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan; 2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study; 3. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours); 4. Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment; 5. Known symptomatic central nervous system (CNS) metastases. 6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases; 7. History of endotracheal or gastrointestinal stent implantation; 8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention; 9. Esophageal or gastric varices requiring immediate intervention; 10. Not eligible to participate in this study at the discretion of the investigator; 11. Do not have adequate treatment washout period before study drug administration. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | 24 months | Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria |
| Number of subjects with clinically significant changes in physical examination results | 24 months | Clinically significant abnormal physical examination findings reported by the investigator. |
| Number of subjects with clinically significant changes in vital signs | 24 months | Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure |
| MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs) | 24 months | Dose limiting toxicity (DLT) to establish MTD or RP2D |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of distribution (V) of IBI3001 | 24 months | Apparent volume of distribution of IBI3001 |
| Half-life (T1/2) of IBI3001 | 24 months | T1/2 of IBI3001 for single and multiple doses |
| Immunogenicity of IBI3001 | 24 months | Incidence of anti-drug (IBI3001) antibody |
| Objective response rate (ORR) | 24 months | ORR as evaluated per the RECIST v1.1 criteria |
| Plasma concentration (Cmax) of IBI3001 | 24 months | Plasma concentration of IBI3001 for single and multiple doses. |
| Disease control rate (DCR) | 24 months | DCR as evaluated per the RECIST v1.1 criteria |
| Time to response (TTR) | 24 months | TTR as evaluated per the RECIST v1.1 criteria |
| Progression free survival (PFS) | 24 months | PFS as evaluated per the RECIST v1.1 criteria |
| Overall survival (OS) | 24 months | Overall survival. |
| Duration of response (DoR) | 24 months | DoR as evaluated per the RECIST v1.1 criteria |
| Area under the curve (AUC) of IBI3001 | 24 months | AUC of IBI3001 for single and multiple doses |
| Time to maximum concentration (Tmax) of IBI3001 | 24 months | Tmax of IBI3001 for single and multiple doses. |
| Clearance (CL) of IBI3001 | 24 months | Clearance of IBI3001 from the plasma |
Countries
Australia, China
Contacts
Primary ContactSujie Zhang
Backup ContactYue Qu
Outcome results
None listed