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Solid TumorsPhase 1NCT04861948

IBI188 Combination Therapy in Solid Tumors

A Phase 1 study testing IBI188, GM-CSF and Cisplatin/Carboplatin in people with Solid Tumors and Lung Adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A Phase Ib study aim to evaluate the efficacy, safety, and tolerability of IBI188 combination therapy in subjects with advanced malignancies Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Solid Tumors, Lung Adenocarcinoma, Osteosarcoma
What is being tested?
IBI188, GM-CSF and Cisplatin/Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
25 May 2021to 30 Jul 2022
Phase
Phase 1
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments .
  • Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).
  • Able to provide archived or fresh tumor tissue samples for biomarker assessment.
  • Have at least one measurable lesion according to RECIST version 1.1.
  • ECCG PS score of 0-2.
  • Adequate organ and bone marrow functions .
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  • Life expectancy ≥ 12 weeks.
  • Female subjects of childbearing potential or male subjects with partners of childbearing potential should take effective contraceptive measures throughout the whole treatment period and until 6 months after treatment.
  • Must voluntarily sign the Informed Consent Form (ICF), and be able to follow all study requirements and procedures. For the subjects enrolled in Cohort C who are ≥ 12 and < 18 years old, in addition to obtaining the child's own consent, their guardians should provide informed consent and sign the ICF.

Who cannot join

  • Previous exposure to any CD47 antibody, SIRPα antibody, CD47/SIRPα recombinant protein or other inhibitors that act in the same pathway.
  • Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).
  • Concurrent participation in another clinical study.
  • The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.
  • Have undergone major surgical procedures within 4 weeks prior to the first dose of study treatment or planned to receive major surgery during the study treatment.
  • Presence of toxicities (excluding alopecia and fatigue) induced by previous anti-tumor therapy that has not recovered to Grade 0 or 1 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 prior to the first dose of study treatment.
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  • Known hypersensitivity to IBI188 or any ingredient in the study drug product.
  • History of other primary malignancies.
  • Female subjects who are pregnant or lactating.
  • Other ineligible conditions considered by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin

Other trials in China

About this study

Official title: Phase Ib Study to Evaluate the Efficacy, Safety and Tolerability of IBI188 Combination Therapy in Subjects With Advanced Malignancies

A Phase Ib study aim to evaluate the efficacy, safety, and tolerability of IBI188 combination therapy in subjects with advanced malignancies

Being tested
IBI188, GM-CSF, Cisplatin/Carboplatin, Bevacizumab, Sintilimab
Medical subject headings
Adenocarcinoma of Lung, Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI188Drug

    intravenous

  • GM-CSFDrug

    subcutaneous injection

  • Cisplatin/CarboplatinDrug

    intravenous

  • BevacizumabDrug

    intravenous

  • SintilimabDrug

    intravenous

  • PemetrexedDrug

    intravenous

Study groups in NCT04861948
Study groupRoleWhat they receive
Cohort AExperimentalNot described
Receives: Drug: IBI188; Drug: Sintilimab
Cohort BExperimentalNot described
Receives: Drug: IBI188; Drug: Cisplatin/Carboplatin; Drug: Bevacizumab; Drug: Pemetrexed
Cohort CExperimentalNot described
Receives: Drug: IBI188; Drug: GM-CSF
Cohort DExperimentalNot described
Receives: Drug: IBI188; Drug: Sintilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Measured: 24 months

  2. Adverse Events

    Incidence, correlation with the study drug and severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)

    Measured: 24 months

Secondary outcomes (13)

  1. Progression-free survival

    Measured: 24 months

  2. Overall survival

    Measured: 24 months

  3. Disease control rate

    Measured: 24 months

  4. Duration of response

    Measured: 24 months

  5. Time to response

    Measured: 24 months

  6. Area Under Curve, AUC

    Measured: 24 months

  7. maximum concentration (Cmax)

    Measured: 24 months

  8. minimum concentration (Cmin)

    Measured: 24 months

  9. clearance (CL)

    Measured: 24 months

  10. volume of distribution (V)

    Measured: 24 months

  11. half-life (t1/2)

    Measured: 24 months

  12. Positive rate of anti-drug antibody (ADA)

    Measured: 24 months

  13. Positive rate of neutralizing antibody (NAb)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2021
  2. Study start25 May 2021
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

Why it stopped: No signs of efficacy in solid tumors

Resources

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04861948
Sponsor's protocol ID
CIBI188A104
Status last verified
Oct 2022
First submitted
22 Apr 2021
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI188, GM-CSF and Cisplatin/Carboplatin in people with Solid Tumors and Lung Adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

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 9 inclusion and 10 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: stopped early, as of the sponsor's last update on 4 Oct 2022. 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 China. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: No signs of efficacy in solid tumors). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04861948.

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 4 Oct 2022.

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