Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Solid Tumors Clinical Trial

Official title:

A Phase 1, Multicenter, Open-label Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06418061
• Other study ID #: CIBI3005A101
• Status: Not yet recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

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