Locally Advanced Solid TumorPhase 1NCT06349408
IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing IBI3001 in people with Locally Advanced Solid Tumor, run by Fortvita Biologics (USA)Inc. at 27 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor
- What is being tested?
- IBI3001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 10 Jan 2025to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants ≥ 18 years old;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Has an anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function:
- 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.
- 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.
Who cannot join
- 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;
- 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;
- Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
- Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
- Known symptomatic central nervous system (CNS) metastases.
- History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
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- History of endotracheal or gastrointestinal stent implantation;
- Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
- Esophageal or gastric varices requiring immediate intervention;
- Not eligible to participate in this study at the discretion of the investigator;
- Do not have adequate treatment washout period before study drug administration. -
Trial locations and contacts
27 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 3 countries
China21 sites, 21 recruiting
- Recruiting
Anyang Cancer Hospital
Anyang, Henan, 455100
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, 610041
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
First Affiliated Hospital, Fujian Medical University
Fuzhou, Fujian, 350005
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
Nanjing, Jiangsu, 210029
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
The Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200120
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
United States4 sites, 3 recruiting
- Recruiting
NEXT Oncology
Dallas, Texas, 75039
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
START Center for Cancer Research
East Brunswick, New Jersey, 08816
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Active, not recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Recruiting
START Center for Cancer Research
Los Angeles, California, 90025
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
Australia2 sites, 2 recruiting
- Recruiting
Cancer Research SA
Adelaide, South Australia, 5000
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Wollongong Hospital
Wollongong, New South Wales, 2500
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
About this study
Official title: 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.
- Conditions
- Locally Advanced Solid Tumor
- Being tested
- IBI3001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3001Drug
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 group | Role | What they receive |
|---|---|---|
| Open-label: IBI3001 monotherapy | Experimental | Not described Receives: Drug: IBI3001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
Measured: 24 months
Number of subjects with clinically significant changes in physical examination results
Clinically significant abnormal physical examination findings reported by the investigator.
Measured: 24 months
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Measured: 24 months
MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)
Dose limiting toxicity (DLT) to establish MTD or RP2D
Measured: 24 months
Secondary outcomes (13)
Plasma concentration (Cmax) of IBI3001
Plasma concentration of IBI3001 for single and multiple doses.
Measured: 24 months
Area under the curve (AUC) of IBI3001
AUC of IBI3001 for single and multiple doses
Measured: 24 months
Time to maximum concentration (Tmax) of IBI3001
Tmax of IBI3001 for single and multiple doses.
Measured: 24 months
Clearance (CL) of IBI3001
Clearance of IBI3001 from the plasma
Measured: 24 months
Volume of distribution (V) of IBI3001
Apparent volume of distribution of IBI3001
Measured: 24 months
Half-life (T1/2) of IBI3001
T1/2 of IBI3001 for single and multiple doses
Measured: 24 months
Immunogenicity of IBI3001
Incidence of anti-drug (IBI3001) antibody
Measured: 24 months
Objective response rate (ORR)
ORR as evaluated per the RECIST v1.1 criteria
Measured: 24 months
Duration of response (DoR)
DoR as evaluated per the RECIST v1.1 criteria
Measured: 24 months
Disease control rate (DCR)
DCR as evaluated per the RECIST v1.1 criteria
Measured: 24 months
Time to response (TTR)
TTR as evaluated per the RECIST v1.1 criteria
Measured: 24 months
Progression free survival (PFS)
PFS as evaluated per the RECIST v1.1 criteria
Measured: 24 months
Overall survival (OS)
Overall survival.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start10 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fortvita Biologics (USA)Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349408
- Sponsor's protocol ID
- CIBI3001A101
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06349408
- Acronym / sponsor ID
- CIBI3001A101
- Conditions
- Locally Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fortvita Biologics (USA)Inc.Industry (pharma, biotech, devices)
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label: IBI3001 monotherapy | Experimental | Drug: IBI3001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants ≥ 18 years old;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Has an anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function:
- 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.
Key exclusion criteria (11 listed)
- 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;
- 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;
- Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
- Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
- Known symptomatic central nervous system (CNS) metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI3001The 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) | Drug | Open-label: IBI3001 monotherapy |
Primary outcome
Number of subjects with adverse events
Time frame: 24 months
Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
Number of subjects with clinically significant changes in physical examination results
Time frame: 24 months
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs
Time frame: 24 months
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)
Time frame: 24 months
Dose limiting toxicity (DLT) to establish MTD or RP2D
13 secondary outcomes
Plasma concentration (Cmax) of IBI3001
Time frame: 24 months
Area under the curve (AUC) of IBI3001
Time frame: 24 months
Time to maximum concentration (Tmax) of IBI3001
Time frame: 24 months
Clearance (CL) of IBI3001
Time frame: 24 months
Volume of distribution (V) of IBI3001
Time frame: 24 months
Half-life (T1/2) of IBI3001
Time frame: 24 months
Immunogenicity of IBI3001
Time frame: 24 months
Objective response rate (ORR)
Time frame: 24 months
Duration of response (DoR)
Time frame: 24 months
Disease control rate (DCR)
Time frame: 24 months
Time to response (TTR)
Time frame: 24 months
Progression free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI3001 in people with Locally Advanced Solid Tumor, run by Fortvita Biologics (USA)Inc. at 27 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fortvita Biologics CT.gov Call Center (650-370-0985, ct.govNotifications@fortvitabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.