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

Phase 1

Recruiting

• Conditions: Locally Advanced Solid Tumor
• Interventions: Drug: IBI3001

• Registration Number: NCT06349408
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Status Verified: 2025-01
• Study Start: 2025-01-10
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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:
5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.

Key

Exclusion Criteria

1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label: IBI3001 monotherapy	IBI3001	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with clinically significant changes in physical examination results	24 months	Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs	24 months	Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Number of subjects with adverse events	24 months	Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)	24 months	Dose limiting toxicity (DLT) to establish MTD or RP2D

Secondary Outcome Measures

Name	Time	Method
Time to maximum concentration (Tmax) of IBI3001	24 months	Tmax of IBI3001 for single and multiple doses.
Clearance (CL) of IBI3001	24 months	Clearance of IBI3001 from the plasma
Half-life (T1/2) of IBI3001	24 months	T1/2 of IBI3001 for single and multiple doses
Immunogenicity of IBI3001	24 months	Incidence of anti-drug (IBI3001) antibody
Overall survival (OS)	24 months	Overall survival.
Plasma concentration (Cmax) of IBI3001	24 months	Plasma concentration of IBI3001 for single and multiple doses.
Progression free survival (PFS)	24 months	PFS as evaluated per the RECIST v1.1 criteria
Area under the curve (AUC) of IBI3001	24 months	AUC of IBI3001 for single and multiple doses
Volume of distribution (V) of IBI3001	24 months	Apparent volume of distribution of IBI3001
Objective response rate (ORR)	24 months	ORR as evaluated per the RECIST v1.1 criteria
Time to response (TTR)	24 months	TTR as evaluated per the RECIST v1.1 criteria
Duration of response (DoR)	24 months	DoR as evaluated per the RECIST v1.1 criteria
Disease control rate (DCR)	24 months	DCR as evaluated per the RECIST v1.1 criteria

Trial Locations

Locations (5)

Cancer Research SA; 🇦🇺 Adelaide, South Australia, Australia

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Wollongong Public; 🇦🇺 Wollongong, New South Wales, Australia