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Clinical Trials in Australia / NCT06349408
Recruiting Phase 1

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

NCT06349408 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2025-01-10
Last updated
2026-09-25

Condition(s) studied

Locally Advanced Solid Tumor

Investigational drug(s) / intervention(s)

IBI3001

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)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. -

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
START Center for Cancer Research Los Angeles California Recruiting
START Center for Cancer Research East Brunswick New Jersey Recruiting
NEXT Oncology Dallas Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Active Not Recruiting
Wollongong Hospital Wollongong New South Wales Recruiting
Cancer Research SA Adelaide South Australia Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Chinese People's Liberation Army General Hospital Beijing Beijing Municipality Recruiting
First Affiliated Hospital, Fujian Medical University Fuzhou Fujian Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
The Affiliated Tumor Hospital of Guangxi Medical University Nanning Guangxi Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
Anyang Cancer Hospital Anyang Henan Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Xiangya Hospital, Central South University Changsha Hunan Recruiting
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University Nanjing Jiangsu Recruiting
Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University) Nanjing Jiangsu Recruiting
Jiangxi Cancer Hospital Nanchang Jiangxi Recruiting
Shanghai East Hospital, Tongji University School of Medicine Shanghai Shanghai Municipality Recruiting
Sichuan Cancer Hospital & Institute Chengdu Sichuan Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06349408 on ClinicalTrials.gov ↗ ← All trials in Australia