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RecruitingNCT06418061Updated Jan 22, 2025

Study of IBI3005 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors

A Phase 1 interventional study of IBI3005 in Unresectable and Locally Advanced or Metastatic Solid Tumors, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.

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

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
198
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.

02

Conditions studied

  • Unresectable
  • Locally Advanced or Metastatic Solid Tumors

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 198 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

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 and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Subjects Should have been previously treated with a third-generation EGFR TKI with disease progression. Subjects with positive other driver genes or METex14 mutations are required to undergo targeted therapy and disease progression.

Exclusion criteria

Exclusion Criteria:

Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study.Patients are allowed to receive inactivated vaccines.

Uncontrolled diseases including:

  • Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug（ antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed）;
  • Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
  • Acute or chronic active hepatitis B (HbsAg positive and/or HbcAb positive with HBV DNA titer ≥ 104 copies/mL or ≥ 2000 IU/mL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer > 103 copies/mL or higher than lower limit of detection);
  • Active COVID-19 infection with obvious symptoms requiring treatment or hospitalization, such as pyrexia, dyspnea, nausea, vomiting, diarrhea, etc.;
  • Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti tuberculosis therapy within 1 year prior to first administration of the study drug;
  • Active syphilis infection or latent syphilis requiring treatment;
  • Symptomatic congestive heart failure Grade II-IV (New York Heart Association [NYHA]), symptomatic or uncontrolled arrhythmias, QTc interval > 480 ms or personal or family history of congenital long/short QT syndrome;
  • Hypertension that does not receive standardized therapy or still uncontrollable hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg); Any history of life-threatening hemorrhage, or hemorrhage requiring (including but not limited to gastrointestinal bleeding, hemoptysis, etc) blood transfusion, endoscopy, or surgery, within 3 months prior to the first administration of study drug;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
198 participants (estimated)

Study arms

  • Experimental
    IBI3005

    Drug: IBI3005

Interventions

  • DrugIBI3005

    Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)

06

What researchers measure

Primary outcomes

  1. Numbers of subjects with adverse events

    defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed

    Time frame: Up to 3 years

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

    Clinically significant abnormal physical examination findings reported by the investigator.

    Time frame: Up to 3 years

  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: Up to 3 years

  4. Dose limiting toxicities (DLTs)

    Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.

    Time frame: Up to 4 weeks

Secondary outcomes

  1. area under the curve (AUC)

    area under the curve (AUC) of single and multiple doses of IBI3005

    Time frame: up to 3 years

  2. maximum concentration (Cmax)

    maximum concentration (Cmax) of single and multiple doses of IBI3005

    Time frame: up to 3 years

  3. time to maximum concentration (Tmax)

    time to maximum concentration (Tmax) of single and multiple doses of IBI3005

    Time frame: up to 3 years

  4. clearance (CL)

    clearance (CL) of single and multiple doses of IBI3005

    Time frame: up to 3 years

  5. apparent volume of distribution (V)

    apparent volume of distribution (V) of single and multiple doses of IBI3005

    Time frame: up to 3 years

  6. half-life (t1/2)

    half-life (t1/2) of IBI3005 to the last administration of IBI3005

    Time frame: up to 3 years

  7. anti-drug antibody (ADA)

    Incidence and characterization of anti-drug antibody (ADA).

    Time frame: up to 3 years

  8. objective response rate (ORR)

    objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.

    Time frame: up to 3 years

  9. duration of response (DoR)

    duration of response (DoR) as evaluated per the RECIST v1.1 criteria.

    Time frame: up to 3 years

  10. time to response (TTR)

    time to response (TTR) as evaluated per the RECIST v1.1 criteria.

    Time frame: up to 3 years

  11. progression free survival (PFS)

    as evaluated per the RECIST v1.1 criteria.

    Time frame: up to 3 years

07

Study locations

1 of 1 sites recruiting
  • Shandong Cancer Hospital & Institute
    JiNan, Shandong 250117, China
    Recruiting
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 Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06418061
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
May 16, 2024
Start date
Jan 8, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 22, 2025

Study contacts

Yanxi Pu
Contact
yanxi.pu@innoventbio.com
18523197816

Oversight

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

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