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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06349408




Registration number
NCT06349408
Ethics application status
Date submitted
1/04/2024
Date registered
5/04/2024
Date last updated
5/04/2024

Titles & IDs
Public title
IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1/2 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
CIBI3001A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IBI3001

Experimental: Open-label: IBI3001 monotherapy -


Treatment: Drugs: 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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Number of subjects with clinically significant changes in physical examination results
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Number of subjects with clinically significant changes in vital signs
Timepoint [3] 0 0
24 months
Primary outcome [4] 0 0
MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)
Timepoint [4] 0 0
24 months
Secondary outcome [1] 0 0
Plasma concentration (Cmax) of IBI3001
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Area under the curve (AUC) of IBI3001
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Time to maximum concentration (Tmax) of IBI3001
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Clearance (CL) of IBI3001
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Volume of distribution (V) of IBI3001
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Half-life (T1/2) of IBI3001
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Immunogenicity of IBI3001
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Objective response rate (ORR)
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Duration of response (DoR)
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Disease control rate (DCR)
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
Time to response (TTR)
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
Progression free survival (PFS)
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
Overall survival (OS)
Timepoint [13] 0 0
24 months

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2027
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Wollongong Public - Wollongong
Recruitment postcode(s) [1] 0 0
2500 - Wollongong

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Innovent Biologics (Suzhou) Co. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06349408
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yue Qu
Address 0 0
Country 0 0
Phone 0 0
+86 18664524992
Fax 0 0
Email 0 0
yue.qu@innoventbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06349408