CClinicalTrials.gg
TerminatedNCT06198426Updated Dec 30, 2025

A Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 interventional study of IBI3004 in Solid Tumor, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Terminated at 5 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
The company's development strategy has been adjusted
Phase
Phase 1/2
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is an open-label, multicenter, dose escalation and expansion phase I /II study of IBI3004 in subjects with unresectable, locally advanced or metastatic solid tumors. It includes a phase 1 dose escalation and expansion section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3004. Accelerated titration and the Bayesian Optimal Interval (BOIN) design is used to find the MTD or RP2D, and the maximum sample size is 46. One or more dose levels will be selected for dose expansion, each dose group will be expanded to 30 subjects.

02

Conditions studied

  • Solid Tumor
03

In context

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
  2. Male or female subjects ≥ 18 years old. For Part 1, age ≥18 and ≤75 years old
  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  4. Anticipated life expectancy of ≥ 12 weeks;
  5. Adequate bone marrow and organ function

Exclusion criteria

Exclusion Criteria:

  1. Enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study;
  2. Received previous anti-tumor therapy: within 21 days of monoclonal antibodies or cytotoxic therapy prior to the first dose of the study drug, or within 14 days of small molecule targeted drugs prior to the first dose of the study drug. Received palliative radiation therapy within 2 weeks prior to the first dose of the study drug, or received radical radiation therapy within 4 weeks prior to the first dose of the study drug;
  3. Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;
  4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
  5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    IBI3004

    Drug: IBI3004

Interventions

  • DrugIBI3004

    IBI3004 will be administered. The Dose Limiting Toxicity (DLT) will be observed in the first treatment cycle. After completion of the DLT observation period, subjects will continue to receive IBI3004 until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.

06

What researchers measure

Primary outcomes

  1. Adverse events (AEs)

    Number of patients who experienced AEs from the first dose until 30 days after the last dose

    Time frame: Up to 30 days post last dose

Secondary outcomes

  1. Dose limiting toxicities (DLTs)

    To evaluate the safety and tolerability of IBI3004

    Time frame: Up to 28 days post first dose

07

Study locations

5 sites
  • Scientia Clinical Research Ltd
    Randwick, New South Wales 2770, Australia
  • Liverpool Hospital
    Sydney, New South Wales 2170, Australia
  • Westmead Hospital
    Sydney, New South Wales 2170, Australia
  • Jiang Su Province Hospital
    Nanjing, Jiangsu 210024, China
  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310009, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06198426
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Jan 10, 2024
Start date
Aug 19, 2024
Primary completion
Dec 16, 2025
Completion
Dec 16, 2025
Last update
Dec 30, 2025

Oversight

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

Not currently enrolling

This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion