IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Locally Advanced Solid Tumor Clinical Trial

Official title:

A Phase 1/2 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06349408
• Other study ID #: CIBI3001A101
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 30, 2024
• Est. completion date: May 30, 2027

Study information

• Verified date: April 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Yue Qu
• Phone: +86 18664524992
• Email: yue.qu[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: May 30, 2027
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

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 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. -

Related Conditions & MeSH terms

• Locally Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Australia	Wollongong Public	Wollongong	New South Wales

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	Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria	24 months
Primary	Number of subjects with clinically significant changes in physical examination results	Clinically significant abnormal physical examination findings reported by the investigator.	24 months
Primary	Number of subjects with clinically significant changes in vital signs	Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure	24 months
Primary	MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)	Dose limiting toxicity (DLT) to establish MTD or RP2D	24 months
Secondary	Plasma concentration (Cmax) of IBI3001	Plasma concentration of IBI3001 for single and multiple doses.	24 months
Secondary	Area under the curve (AUC) of IBI3001	AUC of IBI3001 for single and multiple doses	24 months
Secondary	Time to maximum concentration (Tmax) of IBI3001	Tmax of IBI3001 for single and multiple doses.	24 months
Secondary	Clearance (CL) of IBI3001	Clearance of IBI3001 from the plasma	24 months
Secondary	Volume of distribution (V) of IBI3001	Apparent volume of distribution of IBI3001	24 months
Secondary	Half-life (T1/2) of IBI3001	T1/2 of IBI3001 for single and multiple doses	24 months
Secondary	Immunogenicity of IBI3001	Incidence of anti-drug (IBI3001) antibody	24 months
Secondary	Objective response rate (ORR)	ORR as evaluated per the RECIST v1.1 criteria	24 months
Secondary	Duration of response (DoR)	DoR as evaluated per the RECIST v1.1 criteria	24 months
Secondary	Disease control rate (DCR)	DCR as evaluated per the RECIST v1.1 criteria	24 months
Secondary	Time to response (TTR)	TTR as evaluated per the RECIST v1.1 criteria	24 months
Secondary	Progression free survival (PFS)	PFS as evaluated per the RECIST v1.1 criteria	24 months
Secondary	Overall survival (OS)	Overall survival.	24 months