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Trial Title:
Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT06418061
Condition:
Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI3005
Description:
Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R & D
code: IBI3005)
Arm group label:
IBI3005
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
One Clinical Research Pty Ltd
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Contact:
Last name:
Azim Khan
Phone:
08 6279 9466
Email:
azim.khan@oneclinicalresearch.com.au
Start date:
June 30, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06418061
