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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06418061
Other study ID # CIBI3005A101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date June 30, 2024
Est. completion date June 30, 2027

Study information

Verified date May 2024
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 198
Est. completion date June 30, 2027
Est. primary completion date June 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. Male or female subjects = 18 years old; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 4. Anticipated life expectancy of = 12 weeks; 5. Adequate bone marrow and organ function. 6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerant of standard treatment, or for which no standard treatment is available; Exclusion Criteria: 1. Enrolled in any other interventional clinical research unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study; 2. Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigators' opinion) prior to first administration of the study drug; 3. Multiple concurrent malignant tumors within 5 years: except adequately resected non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured; 4. Allergic or hypersensitive to other monoclonal antibodies and/or exatecan or other camptothecin-derived agents (e.g., topotecan) based therapy, or any ingredients of IBI3005; 5. Not eligible to participate in this study at the discretion of the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IBI3005
Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R & D code: IBI3005)

Locations

Country Name City State
Australia One Clinical Research Pty Ltd Nedlands Western Australia

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 defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed up to 3 years
Primary Number of subjects with clinically significant changes in physical examination results Clinically significant abnormal physical examination findings reported by the investigator. up to 3 years
Primary Number of subjects with clinically significant changes in vital signs Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure up to 3 years
Primary Dose limiting toxicities (DLTs) Dose limiting toxicities (DLTs) to establish MTD and/or RP2D. Up to 4 weeks
Secondary area under the curve (AUC) area under the curve (AUC) of single and multiple doses of IBI3005 up to 3 years
Secondary maximum concentration (Cmax) maximum concentration (Cmax) of single and multiple doses of IBI3005 up to 3 years
Secondary time to maximum concentration (Tmax) time to maximum concentration (Tmax) of single and multiple doses of IBI3005 up to 3 years
Secondary clearance (CL) clearance (CL) of single and multiple doses of IBI3005 up to 3 years
Secondary apparent volume of distribution (V) apparent volume of distribution (V) of single and multiple doses of IBI3005 up to 3 years
Secondary half-life (t1/2) half-life (t1/2) of IBI3005 to the last administration of IBI3005 up to 3 years
Secondary anti-drug antibody (ADA) Incidence and characterization of anti-drug antibody (ADA). up to 3 years
Secondary objective response rate (ORR) objective response rate (ORR) as evaluated per the RECIST v1.1 criteria. up to 3 years
Secondary duration of response (DoR) duration of response (DoR) as evaluated per the RECIST v1.1 criteria. up to 3 years
Secondary time to response (TTR) time to response (TTR) as evaluated per the RECIST v1.1 criteria. up to 3 years
Secondary progression free survival (PFS) as evaluated per the RECIST v1.1 criteria. up to 3 years
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