Solid TumorPhase 1/2NCT05923008
A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing IBI130 in people with Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- IBI130
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Nov 2023to 31 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- 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;
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function
Who cannot join
- 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;
- 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;
- 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;
- Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Sunshine Coast University
Birtinya, Queensland, 4575
Michelle Morris, 07 53906057, morrismi2@ramsayhealth.com.au
About this study
Official title: A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
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.
- Conditions
- Solid Tumor
- Being tested
- IBI130
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI130Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| IBI130 | Experimental | IBI130 Receives: Drug: IBI130 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Measured: Up to 30 days post last dose
Secondary outcomes (3)
objective response rate (ORR)
ORR is the percentage of complete response(CR) plus partial response assessed(PR) per RECIST v1.1 criteria
Measured: Time from first dose to best response to treatment, assessed up to 3 years
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
Measured: 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
overall survival (OS)
Time from the date of the first dose to death of the subject due to any cause
Measured: Time from first dose to death, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start14 Nov 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923008
- Sponsor's protocol ID
- CIBI130A101
- Status last verified
- Nov 2023
- First submitted
- 19 Jun 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05923008
- Acronym / sponsor ID
- CIBI130A101
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 Jun 2023 (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 1/2 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI130 | Experimental | Drug: IBI130IBI130 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function
Key exclusion criteria (4 listed)
- 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;
- 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;
- 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;
- Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;
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 |
|---|---|---|
| IBI130Subjects 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. | Drug | IBI130 |
Primary outcome
Adverse events (AEs)
Time frame: Up to 30 days post last dose
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
3 secondary outcomes
objective response rate (ORR)
Time frame: Time from first dose to best response to treatment, assessed up to 3 years
duration of response(DoR)
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
overall survival (OS)
Time frame: Time from first dose to death, assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IBI130 in people with Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in Australia.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serena Dong (0512 69566088, suhua.dong@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Up to 30 days post last dose). 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 29 Nov 2023.