Locally Advanced Solid Tumor Clinical Trial
Official title:
A Phase 1/2 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
This is a Phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. It includes a Phase 1 section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3001, and a Phase 2 section to explore and confirm the efficacy, safety and tolerability of IBI3001 at its RP2D.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | May 30, 2027 |
Est. primary completion date | May 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: Criteria for Phase 1 only: 1. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. 2. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment. Key Exclusion Criteria: 1. Progressed or refractory to an antibody drug conjugate that consists of a topoisomerase I inhibitor; 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. - |
Country | Name | City | State |
---|---|---|---|
Australia | Wollongong Public | Wollongong | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Innovent Biologics (Suzhou) Co. Ltd. |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects with adverse events | Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria | 24 months | |
Primary | Number of subjects with clinically significant changes in physical examination results | Clinically significant abnormal physical examination findings reported by the investigator. | 24 months | |
Primary | Number of subjects with clinically significant changes in vital signs | Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure | 24 months | |
Primary | MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs) | Dose limiting toxicity (DLT) to establish MTD or RP2D | 24 months | |
Secondary | Plasma concentration (Cmax) of IBI3001 | Plasma concentration of IBI3001 for single and multiple doses. | 24 months | |
Secondary | Area under the curve (AUC) of IBI3001 | AUC of IBI3001 for single and multiple doses | 24 months | |
Secondary | Time to maximum concentration (Tmax) of IBI3001 | Tmax of IBI3001 for single and multiple doses. | 24 months | |
Secondary | Clearance (CL) of IBI3001 | Clearance of IBI3001 from the plasma | 24 months | |
Secondary | Volume of distribution (V) of IBI3001 | Apparent volume of distribution of IBI3001 | 24 months | |
Secondary | Half-life (T1/2) of IBI3001 | T1/2 of IBI3001 for single and multiple doses | 24 months | |
Secondary | Immunogenicity of IBI3001 | Incidence of anti-drug (IBI3001) antibody | 24 months | |
Secondary | Objective response rate (ORR) | ORR as evaluated per the RECIST v1.1 criteria | 24 months | |
Secondary | Duration of response (DoR) | DoR as evaluated per the RECIST v1.1 criteria | 24 months | |
Secondary | Disease control rate (DCR) | DCR as evaluated per the RECIST v1.1 criteria | 24 months | |
Secondary | Time to response (TTR) | TTR as evaluated per the RECIST v1.1 criteria | 24 months | |
Secondary | Progression free survival (PFS) | PFS as evaluated per the RECIST v1.1 criteria | 24 months | |
Secondary | Overall survival (OS) | Overall survival. | 24 months |
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