CClinicalTrials.gg
Sign In
RecruitingNCT05923008Updated Nov 29, 2023

A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 interventional study of IBI130 in Solid Tumor, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.

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

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
182
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to enroll 20\~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects will be enrolled for phase 2.

02

Conditions studied

  • Solid Tumor

Browse trials for

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 182 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

  1. Subjects with 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;
  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 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter;
  3. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
  4. Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
182 participants (estimated)

Study arms

  • Experimental
    IBI130

    IBI130

    Drug: IBI130

Interventions

  • DrugIBI130

    Subjects will receive IBI130 until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.

06

What researchers measure

Primary outcomes

  1. Adverse events (AEs)

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

    Time frame: Up to 30 days post last dose

Secondary outcomes

  1. objective response rate (ORR)

    ORR is the percentage of complete response(CR) plus partial response assessed(PR) per RECIST v1.1 criteria

    Time frame: Time from first dose to best response to treatment, assessed up to 3 years

  2. duration of response(DoR)

    For subjects with CR or PR,duration of response(DoR) is the time from the first documented CR or PR to disease progression assessed per RESICT v1.1 criteria or death

    Time frame: Duration of response from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression, assessed up to 3 years

  3. overall survival (OS)

    Time from the date of the first dose to death of the subject due to any cause

    Time frame: Time from first dose to death, assessed up to 3 years

07

Study locations

1 of 1 sites recruiting
  • Sunshine Coast University
    Birtinya, Queensland 4575, Australia
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05923008
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Jun 28, 2023
Start date
Nov 14, 2023
Primary completion
Nov 30, 2024 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Nov 29, 2023

Study contacts

Serena Dong
Contact
suhua.dong@innoventbio.com
0512 69566088

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

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.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Start the discussion