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RecruitingNCT06349408Updated Sep 25, 2026

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

A Phase 1 interventional study of IBI3001 in Locally Advanced Solid Tumor, sponsored by Fortvita Biologics (USA)Inc.. Recruiting at 27 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Fortvita Biologics (USA)Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Updated Sep 25, 2026First site in United StatesSponsor changed+2 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Locally Advanced Solid Tumor
03

In context

Lead sponsor

Fortvita Biologics (USA)Inc. is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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. -
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Open-label: IBI3001 monotherapy

    Drug: IBI3001

Interventions

  • DrugIBI3001

    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)

06

What researchers measure

Primary outcomes

  1. Number of subjects with adverse events

    Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria

    Time frame: 24 months

  2. Number of subjects with clinically significant changes in physical examination results

    Clinically significant abnormal physical examination findings reported by the investigator.

    Time frame: 24 months

  3. Number of subjects with clinically significant changes in vital signs

    Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure

    Time frame: 24 months

  4. MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)

    Dose limiting toxicity (DLT) to establish MTD or RP2D

    Time frame: 24 months

Secondary outcomes

  1. Plasma concentration (Cmax) of IBI3001

    Plasma concentration of IBI3001 for single and multiple doses.

    Time frame: 24 months

  2. Area under the curve (AUC) of IBI3001

    AUC of IBI3001 for single and multiple doses

    Time frame: 24 months

  3. Time to maximum concentration (Tmax) of IBI3001

    Tmax of IBI3001 for single and multiple doses.

    Time frame: 24 months

  4. Clearance (CL) of IBI3001

    Clearance of IBI3001 from the plasma

    Time frame: 24 months

  5. Volume of distribution (V) of IBI3001

    Apparent volume of distribution of IBI3001

    Time frame: 24 months

  6. Half-life (T1/2) of IBI3001

    T1/2 of IBI3001 for single and multiple doses

    Time frame: 24 months

  7. Immunogenicity of IBI3001

    Incidence of anti-drug (IBI3001) antibody

    Time frame: 24 months

  8. Objective response rate (ORR)

    ORR as evaluated per the RECIST v1.1 criteria

    Time frame: 24 months

  9. Duration of response (DoR)

    DoR as evaluated per the RECIST v1.1 criteria

    Time frame: 24 months

  10. Disease control rate (DCR)

    DCR as evaluated per the RECIST v1.1 criteria

    Time frame: 24 months

  11. Time to response (TTR)

    TTR as evaluated per the RECIST v1.1 criteria

    Time frame: 24 months

  12. Progression free survival (PFS)

    PFS as evaluated per the RECIST v1.1 criteria

    Time frame: 24 months

  13. Overall survival (OS)

    Overall survival.

    Time frame: 24 months

07

Study locations

26 of 27 sites recruiting
  • START Center for Cancer Research
    Los Angeles, California 90025, United States
    Recruiting
  • START Center for Cancer Research
    East Brunswick, New Jersey 08816, United States
    Recruiting
  • NEXT Oncology
    Dallas, Texas 75039, United States
    Recruiting
  • Virginia Cancer Specialists
    Fairfax, Virginia 22031, United States
    Active, not recruiting
  • Wollongong Hospital
    Wollongong, New South Wales 2500, Australia
    Recruiting
  • Cancer Research SA
    Adelaide, South Australia 5000, Australia
    Recruiting
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230022, China
    Recruiting
  • Cancer Hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality 100021, China
    Recruiting
  • Chinese People's Liberation Army General Hospital
    Beijing, Beijing Municipality 100853, China
    Recruiting
  • First Affiliated Hospital, Fujian Medical University
    Fuzhou, Fujian 350005, China
    Recruiting
  • Fujian Cancer Hospital
    Fuzhou, Fujian 350014, China
    Recruiting
  • The Affiliated Tumor Hospital of Guangxi Medical University
    Nanning, Guangxi 530021, China
    Recruiting
  • Harbin Medical University Cancer Hospital
    Harbin, Heilongjiang 150081, China
    Recruiting
  • Anyang Cancer Hospital
    Anyang, Henan 455100, China
    Recruiting
  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, Henan 471003, China
    Recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan 450008, China
    Recruiting
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450052, China
    Recruiting
  • Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
    Recruiting
  • Xiangya Hospital, Central South University
    Changsha, Hunan 410008, China
    Recruiting
  • Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
    Nanjing, Jiangsu 210008, China
    Recruiting
  • Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
    Nanjing, Jiangsu 210029, China
    Recruiting
  • Jiangxi Cancer Hospital
    Nanchang, Jiangxi 330029, China
    Recruiting
  • Shanghai East Hospital, Tongji University School of Medicine
    Shanghai, Shanghai Municipality 200120, China
    Recruiting
  • Sichuan Cancer Hospital & Institute
    Chengdu, Sichuan 610041, China
    Recruiting
  • West China Hospital, Sichuan University
    Chengdu, Sichuan 610041, China
    Recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310003, China
    Recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
26 sites added, 4 sites removed — first site in United States
Show 26 added (21 China, 4 United States, 1 Australia)
  • START Center for Cancer Research · Los Angeles, United States
  • START Center for Cancer Research · East Brunswick, United States
  • NEXT Oncology · Dallas, United States
  • Virginia Cancer Specialists · Fairfax, United States
  • Wollongong Hospital · Wollongong, Australia
  • The First Affiliated Hospital of Anhui Medical University · Hefei, China
  • Cancer Hospital, Chinese Academy of Medical Sciences · Beijing, China
  • Chinese People's Liberation Army General Hospital · Beijing, China
  • First Affiliated Hospital, Fujian Medical University · Fuzhou, China
  • Fujian Cancer Hospital · Fuzhou, China
  • The Affiliated Tumor Hospital of Guangxi Medical University · Nanning, China
  • Harbin Medical University Cancer Hospital · Harbin, China
  • Anyang Cancer Hospital · Anyang, China
  • The First Affiliated Hospital of Henan University of Science and Technology · Luoyang, China
  • Henan Cancer Hospital · Zhengzhou, China
  • The First Affiliated Hospital of Zhengzhou University · Zhengzhou, China
  • Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, China
  • Xiangya Hospital, Central South University · Changsha, China
  • Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University · Nanjing, China
  • Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University) · Nanjing, China
  • Jiangxi Cancer Hospital · Nanchang, China
  • Shanghai East Hospital, Tongji University School of Medicine · Shanghai, China
  • Sichuan Cancer Hospital & Institute · Chengdu, China
  • West China Hospital, Sichuan University · Chengdu, China
  • The First Affiliated Hospital, Zhejiang University School of Medicine · Hangzhou, China
  • Zhejiang Cancer Hospital · Hangzhou, China
Show 4 removed
  • Wollongong Public · Wollongong, Australia
  • Chinese PLA General Hospital · Beijing, China
  • Shanghai East Hospital · Shanghai, China
  • The First Affiliated Hospital of zhejiang University School of Medicine · Hangzhou, China
Sep 25, 2026
Also revised
sponsor
Show all 1 update
  1. Sep 25, 2026
    26 sites added, 4 sites removed — first site in United States
    Show 26 added (21 China, 4 United States, 1 Australia)
    • START Center for Cancer Research · Los Angeles, United States
    • START Center for Cancer Research · East Brunswick, United States
    • NEXT Oncology · Dallas, United States
    • Virginia Cancer Specialists · Fairfax, United States
    • Wollongong Hospital · Wollongong, Australia
    • The First Affiliated Hospital of Anhui Medical University · Hefei, China
    • Cancer Hospital, Chinese Academy of Medical Sciences · Beijing, China
    • Chinese People's Liberation Army General Hospital · Beijing, China
    • First Affiliated Hospital, Fujian Medical University · Fuzhou, China
    • Fujian Cancer Hospital · Fuzhou, China
    • The Affiliated Tumor Hospital of Guangxi Medical University · Nanning, China
    • Harbin Medical University Cancer Hospital · Harbin, China
    • Anyang Cancer Hospital · Anyang, China
    • The First Affiliated Hospital of Henan University of Science and Technology · Luoyang, China
    • Henan Cancer Hospital · Zhengzhou, China
    • The First Affiliated Hospital of Zhengzhou University · Zhengzhou, China
    • Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, China
    • Xiangya Hospital, Central South University · Changsha, China
    • Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University · Nanjing, China
    • Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University) · Nanjing, China
    • Jiangxi Cancer Hospital · Nanchang, China
    • Shanghai East Hospital, Tongji University School of Medicine · Shanghai, China
    • Sichuan Cancer Hospital & Institute · Chengdu, China
    • West China Hospital, Sichuan University · Chengdu, China
    • The First Affiliated Hospital, Zhejiang University School of Medicine · Hangzhou, China
    • Zhejiang Cancer Hospital · Hangzhou, China
    Show 4 removed
    • Wollongong Public · Wollongong, Australia
    • Chinese PLA General Hospital · Beijing, China
    • Shanghai East Hospital · Shanghai, China
    • The First Affiliated Hospital of zhejiang University School of Medicine · Hangzhou, China
    Sponsor Innovent Biologics (Suzhou) Co. Ltd.→Fortvita Biologics (USA)Inc.
    + 5 other changes: identifiers, verification date, oversight details, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06349408
Lead sponsor
Fortvita Biologics (USA)Inc.
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Apr 5, 2024
Start date
Jan 10, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Fortvita Biologics CT.gov Call Center
Contact
ct.govNotifications@fortvitabio.com
650-370-0985

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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