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Advanced MalignanciesPhase 1NCT03717103

A Phase 1 Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI188 in Advanced Malignancies

A Phase 1 study testing IBI188 in people with Advanced Malignancies, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy in patients with advanced malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignancies
What is being tested?
IBI188
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteChina
Study dates
10 Jan 2019to 16 Feb 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced solid tumors and lymphomas defined by:
  • Histologically/cytologically confirmed solid tumors and lymphomas
  • Solid Tumors failed from standard therapy
  • Lymphoma patients who have had at least two standard treatment failures
  • Subject has at least 1 measurable disease per RECIST v1.1. Lymphomas have at least one measurable lesion and 18FDG-avid lesion according to the Lugano 2014 criteria.
  • Male or female subject above 18 years
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  • ECOG Performance Status 0 to 1
  • Must have adequate organ and bone marrow function, including the following:
  • Blood routine: absolute neutrophil count (ANC) ≥ 1.5 x10^9/L; platelet count ≥ 75 x 10^9/L; hemoglobin ≥ 10 g/dL. (For subjects with AML, WBC < 25×10^9/L was required , and there is no restriction for the rest in blood routine test ).
  • Hepatic: total bilirubin ≤ 1.5 times of the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 X ULN (≤5 X ULN if with liver involvement). total bilirubin ≤ 3×ULN if subjects were diagnosed with Gilbert syndrome.
  • Renal: serum creatinine ≤ 1.5 X ULN or estimated creatinine clearance ≥50mL/min. Urinary protein < 2+. For subjects with urinary protein ≥2+ at baseline, a 24h urine collection should be performed with urine protein < 1g.
  • Coagulation tests INR < 1.5, partial prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
  • Subjects with life expectancy of ≥ 12 weeks
  • Female subjects of child-bearing potential or male subjects with female partners of child-bearing potential must be willing to use viable contraception method that is deemed effective by the investigator throughout the treatment period and for at least 6 months following the last dose of study drug.
  • Be willing to sign the Informed Consent Form (ICF), and can follow the visit schedule and procedures defined in the protocol.

Who cannot join

  • Previous exposure to any anti-CD47 monoclonal antibody or SIRPα antibody.
  • Subjects participating in any other interventional clinical study
  • Received blood transfusion, biologic G-CSF, GM-CSF, erythropoietin, thrombopoietin (TPO) or IL-11within 3 weeks prior to the first dose of study drug
  • Receive the last dose of anti-tumor therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization, etc.) within 3 weeks before the first dose of the study.
  • Immunosuppressive drugs were used within 7 days before the first dose of the study
  • Plan to receive live attenuated vaccines within 4 weeks before the first dose treatment or during the study period.
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  • Has undergone major surgery (craniotomy, thoracotomy or laparotomy) or is expected to require major surgery during the first dose of the study.
  • Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v5.0, with exception of the residual hair loss nor fatigue
  • Had received total pelvic radiotherapy before.
  • Central nervous system metastases:
  • Subjects with active or suspected autoimmune disease or a history of the disease in the past two years
  • known history of primary immunodeficiency.
  • known history of active pulmonary tuberculosis.
  • known history of allograft transplantation and history of allogeneic hematopoietic stem cell transplantation.
  • known to be allergic to any IBI188 preparations.
  • Ascites of clinical significance, including any ascites that may be detected by physical examination, previously treated or still in need of treatment, may be enrolled if only a small amount of ascites is shown on imaging but asymptomatic.
  • 18. Subjects with moderate bilateral pleural effusion, or massive pleural effusion on one side, or respiratory dysfunction requiring drainage.
  • 19. Pregnant or nursing females.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: A Phase 1 Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignancies

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy in patients with advanced malignancies.

Read the detailed description

Phase Ia study is composed of two stages: Phase Ia Part A initial dose escalation and Phase Ia Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design. The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 2 dose cohorts (0.3 mg/kg QW and 1 mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.

Phase Ia Part B will have 4 dose cohorts(3mg/kg QW#10mg/kg QW#20mg/kg QW #30mg/kg QW and 45mg/kg Q3W). DLT observation period is 28 days. The subject number for each cohort in Phase Ia Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6

Being tested
IBI188

What participants receive

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

  • IBI188Drug

    Also called Letaplimab

    Part A: 0.1 mg/kg IV QW, 0.3 mg/kg IV QW, 1 mg/kg IV QW. Part B: 1mg/kg IV D1+3, 10, 20, 30 mg/kg IV D8 QW or 45mg/kg D8 IV Q3W.

Study groups in NCT03717103
Study groupRoleWhat they receive
IBI188ExperimentalPart A : Initial dose escalation, Part B : Maintenance dose escalation
Receives: Drug: IBI188

What is being measured

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

  1. Adverse events (AEs), Serious Adverse Events (SAE)Number of patients with AEs and SAEs

    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 (4)

  1. Preliminary anti-tumor activity of IBI188 (Objective Response Rate)

    Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma.

    Measured: 24 months

  2. Pharmacokinetics: Cmax

    Maximum concentration(Cmax) of the drug after administration

    Measured: 24 months

  3. Pharmacokinetics: AUC

    The area under the curve (AUC) of serum concentration of the drug after the administration.

    Measured: 24 months

  4. Immunogenicity

    Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of IBI188.

    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 posted24 Oct 2018
  2. Study start10 Jan 2019
  3. Primary completion16 Feb 2022
  4. Study completion16 Feb 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03717103
Sponsor's protocol ID
CIBI188A101
Status last verified
Mar 2022
First submitted
22 Oct 2018
Last updated
7 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cai S, Wei X, Li Q, Jiang Z, Li L. Smart materials in pharmacological drug development: Neutrophils and its constituents for drug delivery and consequent antitumor effects. Mol Immunol. 2025 Jul;183:18-32. doi: 10.1016/j.molimm.2025.04.010. Epub 2025 May 2.

    PubMed 40318595

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI188 in people with Advanced Malignancies, 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 15 inclusion and 18 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: finished, as of the sponsor's last update on 7 Apr 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse events (AEs), Serious Adverse Events (SAE)Number of patients with AEs and SAEs (time frame: 24 months). 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 NCT03717103, which also lists 1 linked publication.

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 7 Apr 2022.

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