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NCT06349408PHASE1Recruiting

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

Fortvita Biologics (USA)Inc.

Start Date

1/10/2025

Completion Date

12/31/2027

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 Criteria

Age Range: 18 years to No maximum

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. -

Interventions

DRUG

IBI3001

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Conditions

Locally Advanced Solid Tumor

Locations

START Center for Cancer Research

Los Angeles, California 90025

United States

START Center for Cancer Research

East Brunswick, New Jersey 08816

United States

NEXT Oncology

Dallas, Texas 75039

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Wollongong Hospital

Wollongong, New South Wales 2500

Australia

Cancer Research SA

Adelaide, South Australia 5000

Australia

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui 230022

China

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality 100021

China

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality 100853

China

First Affiliated Hospital, Fujian Medical University

Fuzhou, Fujian 350005

China

Fujian Cancer Hospital

Fuzhou, Fujian 350014

China

The Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi 530021

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150081

China

Anyang Cancer Hospital

Anyang, Henan 455100

China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan 471003

China

Henan Cancer Hospital

Zhengzhou, Henan 450008

China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan 450052

China

Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei 430022

China

Xiangya Hospital, Central South University

Changsha, Hunan 410008

China

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu 210008

China

Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)

Nanjing, Jiangsu 210029

China

Jiangxi Cancer Hospital

Nanchang, Jiangxi 330029

China

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality 200120

China

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan 610041

China

West China Hospital, Sichuan University

Chengdu, Sichuan 610041

China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang 310003

China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang 310022

China