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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: IBI3005

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • One Clinical Research Pty Ltd
      • Contact: Azim Khan; Phone Number: 08 6279 9466; Email: azim.khan@oneclinicalresearch.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI3005	Drug: IBI3005; Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R & D code: IBI3005)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Dose limiting toxicities (DLTs)	Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
area under the curve (AUC)	area under the curve (AUC) of single and multiple doses of IBI3005	up to 3 years
maximum concentration (Cmax)	maximum concentration (Cmax) of single and multiple doses of IBI3005	up to 3 years
time to maximum concentration (Tmax)	time to maximum concentration (Tmax) of single and multiple doses of IBI3005	up to 3 years
clearance (CL)	clearance (CL) of single and multiple doses of IBI3005	up to 3 years
apparent volume of distribution (V)	apparent volume of distribution (V) of single and multiple doses of IBI3005	up to 3 years
half-life (t1/2)	half-life (t1/2) of IBI3005 to the last administration of IBI3005	up to 3 years
anti-drug antibody (ADA)	Incidence and characterization of anti-drug antibody (ADA).	up to 3 years
objective response rate (ORR)	objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.	up to 3 years
duration of response (DoR)	duration of response (DoR) as evaluated per the RECIST v1.1 criteria.	up to 3 years
time to response (TTR)	time to response (TTR) as evaluated per the RECIST v1.1 criteria.	up to 3 years
progression free survival (PFS)	as evaluated per the RECIST v1.1 criteria.	up to 3 years

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI3005A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No