Actively Recruiting
A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2026-05-04
470
Participants Needed
39
Research Sites
270 weeks
Total Duration
On this page
Sponsors
I
Innovent Biologics (Suzhou) Co. Ltd.
Lead Sponsor
F
Fortvita Biologics (USA)Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase Ia/Ib, multicenter, open-label, first-in-human study to evaluate the safety, tolerability, PK, and efficacy of IBI343 in participants with locally advanced unresectable or metastatic solid tumors. It is planned to be carried out in different countries or regions such as China, Australia and US. There are three parts in phase Ia. Part 1 includes dose escalation and expansion phase and part 2 is designed for dose optimization for IBI343 monotherapy. Part 3 1L G/GEJ AC and 1L PDAC cohorts will include an initial safety lead-in stage to confirm the tolerability of IBI343 in combination with chemotherapy in 1L PDAC and G/GEJ AC, followed by a randomized dose-optimization stage designed to further characterize safety, pharmacokinetics, and preliminary efficacy to inform selection of the recommended Phase 3 dose.
CONDITIONS
Official Title
A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to comply with study visits and procedures
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate bone marrow, liver, kidney, and coagulation function as defined by study criteria
- At least one measurable lesion according to RECIST v1.1 criteria
- For Phase Ia dose escalation: unresectable locally advanced or metastatic malignant solid tumors with no effective standard therapy
- For Phase Ia dose expansion and optimization: confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma, pancreatic ductal adenocarcinoma, biliary tract cancer, or other solid tumors with CLDN18.2-positive tumors
- Female participants of childbearing potential and male participants with female partners of childbearing potential must use effective contraception during treatment and for 6 months after
- Specific cohorts require treatment-naive or previously treated status as detailed in the protocol
- Confirmed CLDN18.2 expression levels per cohort requirements
You will not qualify if you...
- Participation in other interventional clinical studies or survival follow-up phase of such studies
- Received antineoplastic therapy within 4 weeks or 5 half-lives before study drug
- Planned concurrent anti-tumor therapies except allowed palliative radiotherapy
- Recent use of strong CYP3A4 inhibitors within 2 weeks prior to study drug
- Unresolved toxicities from prior therapies above Grade 1 except specified conditions
- Major surgery or unhealed wounds within 4 weeks before study drug or planned surgery during study
- Gastric pyloric obstruction or frequent vomiting
- Recent gastrointestinal perforation or fistula not surgically resolved
- Symptomatic central nervous system metastases or unstable brain metastases
- History of pneumonitis requiring steroids or severe lung disease
- Uncontrolled infections, active HIV, hepatitis B or C infections above defined thresholds
- Active tuberculosis or syphilis requiring treatment
- Symptomatic heart failure, arrhythmias, QTc prolongation, or uncontrolled hypertension
- Recent arterial thromboembolic events or stent implantation in tracheal/digestive tract
- Symptomatic pleural, ascitic, or pericardial effusions requiring intervention
- High risk or recent gastrointestinal bleeding or varices requiring intervention
- Recent serious venous thromboembolism
- Certain liver conditions including hepatic encephalopathy or severe cirrhosis
- Intestinal or bowel obstruction or diseases increasing risk of perforation
- Other acute or chronic diseases or abnormalities increasing study risk or affecting compliance
- Neurological or psychiatric illness impairing study participation or consent
- History of other malignancies except specified treated conditions
- Known immunodeficiency or history of organ or stem cell transplantation
- Severe allergic reaction to monoclonal antibodies or study drug components
- Pregnant or lactating females
- Known dihydropyrimidine dehydrogenase deficiency
- Peripheral sensory neuropathy above grade 1 unless specific exception applies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Next Oncology-Austin
Austin, Texas, United States, 78758
Actively Recruiting
2
Next Oncology-Dallas
Irving, Texas, United States, 75039
Actively Recruiting
3
Next Oncology-San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
4
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
5
Cancer Care Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
6
Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Active, Not Recruiting
7
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
8
Anhui Cancer Hospital
Hefei, Anhui, China
Actively Recruiting
9
Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
10
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Actively Recruiting
11
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
12
Tumor Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
13
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
14
Sun Yat-sen Memorial Hospital Sun Yat-Sen university
Guangzhou, Guangzhou, China
Actively Recruiting
15
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangzhou, China
Actively Recruiting
16
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
17
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
18
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
19
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technolog
Wuhan, Hubei, China
Actively Recruiting
20
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
21
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
22
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Actively Recruiting
23
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
24
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
25
Ningxia Medical University General Hospital
Yinchuan, Ningxia, China
Actively Recruiting
26
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Actively Recruiting
27
Jinan Central Hospital
Jinan, Shandong, China
Actively Recruiting
28
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
29
Jining First People's Hospital
Jining, Shandong, China
Actively Recruiting
30
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
31
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
32
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
33
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
34
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
35
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
36
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
37
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
38
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
39
Ningbo Medical Center Li Huili Hospital
Ningbo, Zhejiang, China
Actively Recruiting
Research Team
S
Suhua Dong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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