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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06349408
Other study ID # CIBI3001A101
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 30, 2024
Est. completion date May 30, 2027

Study information

Verified date April 2024
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact Yue Qu
Phone +86 18664524992
Email yue.qu@innoventbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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. -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IBI3001
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)

Locations

Country Name City State
Australia Wollongong Public Wollongong New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

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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