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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Solid Tumor
• Intervention / Treatment: Drug: IBI3001

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sujie Zhang; Phone Number: 86-13811303576; Email: sujie.zhang@innoventbio.com
• Study Contact Backup: Name: Yue Qu; Phone Number: 86-18664524992; Email: yue.qu@innoventbio.com

Study Locations

• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia, 2500
      • Recruiting
      • Wollongong Public
      • Contact: Daniel Brungs; Email: Daniel.brungs@health.nsw.gov.au
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Cancer Research SA
      • Contact: Vineet Kwatra; Phone Number: 61883592565; Email: vkwatra@crsa.au
• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Not yet recruiting
      • Chinese PLA General Hospital
      • Contact: Yi Hu; Phone Number: 13911031189; Email: huyi0401@aliyun.com
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Not yet recruiting
      • Shanghai East Hospital
      • Contact: Caicun Zhou; Phone Number: 13301825532; Email: caicunzhoudr@163.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Not yet recruiting
      • The First Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Tingbo Liang; Phone Number: 13666676128; Email: liangtingbo_trial@163.com

Participation Criteria

Eligibility Criteria

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

Description

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:
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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label: IBI3001 monotherapy	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events	Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria	24 months
Number of subjects with clinically significant changes in physical examination results	Clinically significant abnormal physical examination findings reported by the investigator.	24 months
Number of subjects with clinically significant changes in vital signs	Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure	24 months
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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI3001A101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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