NCT06349408From ClinicalTrials.govRecruiting

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

Locally Advanced Solid Tumor

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: Fortvita Biologics (USA)Inc.
Enrolment target: 250
Started: 10 January 2025
Main results due: 31 December 2026
Study sites: 27
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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. -

What this study is about

In the sponsor’s own words, from the registry.

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 sites(27)

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

Showing 27 of 27 sites. 26 of the 27 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06349408. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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