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Advanced MalignanciesPhase 1NCT03763149

A 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 Malignant Tumors and Lymphomas

A Phase 1 study testing IBI188 in people with Advanced Malignancies, run by Innovent Biologics (Suzhou) Co. Ltd. at 4 sites in United States.

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
20 participants
Where
4 sitesUnited States
Study dates
19 Feb 2019to 29 Mar 2021
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

  • Able to understand and willing to sign the ICF.
  • Male or female subject above18 years.
  • Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory to standard therapy, or for which no standard therapy exists.
  • For dose expansion at the RP2D: subject has measurable disease per RECIST v1.1. that was not in a prior radiation area within past 6 months, unless tumor growth was documented following radiation. Lymphomas have at least one measurable lesion and FDG-avid lesion according to the Lugano 2014 criteria.
  • Separate informed consent for subjects who provide archived tissue biopsies for biomarker testing (Optional).
  • ECOG Performance Status 0 to 1
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  • Subjects with life expectancy of ≥ 3 month
  • No herbal/alternative medications within 14 days prior to the first dose of IBI188.
  • Must have adequate organ function, prior to start of IBI188, including the following:
  • Bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 x109/L; platelet count ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L; Lymphocyte counts ≥ 0.5 x109/L
  • Hepatic: total bilirubin ≤ 1.5 times 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)
  • Renal: serum creatinine ≤ 1.5 times the ULN or estimated creatinine clearance ≥50mL/min (Cockroft and Gault formula [https://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation]).
  • Coagulation tests INR < 2.0, activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
  • Subjects (women of child-bearing potential and males) must be willing to use viable contraception method that is deemed effective by the investigator throughout the treatment period and for at least three months following the last dose of study drug. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.

Who cannot join

  • Pregnant or nursing females.
  • Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v5.0, with exception of the residual hair loss;
  • Received a biologic G-CSF, GM-CSF or erythropoietin within 14 days prior to the first dose of study drug;
  • Subjects participating in any other interventional clinical study
  • Previous exposure to any anti-CD47 monoclonal antibody or SIRPα antibody.
  • Subjects who had transfusion within 3 weeks
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  • Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroidal anti-inflammatory medications.
  • Subjects who have a history of documented autoimmune disease, even if not clinically severe or never treated with systemic steroids or immunosuppressive agents, are not candidates for this clinical trial, except for autoimmune hypothyroidism and well-controlled Type 1 diabetes mellitus.
  • Subjects with or w/o autoimmune condition requiring systemic treatment with either corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the planned first dose of study drug. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Ophthalmologic, nasal and intra-articular injections or steroids are acceptable.
  • Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS metastases are not allowed. Subjects with asymptomatic CNS metastases are eligible if clinically controlled, which is defined as ≥8 weeks of stable neurologic function following CNS-directed therapy, and no evidence of CNS disease progression as determined by radiographic imaging ≥ 4 weeks prior to screening. No interim progression between the completion of CNS-directed therapy and the screening tumor assessment, and ≥ 2 weeks from discontinuation of anti-seizure and steroid therapies from screening.
  • Subjects who have had major surgery within the 28-days from the screening;
  • Subjects with idiopathic pulmonary fibrosis or unresolved active or chronic inflammatory pulmonary disease are excluded. Subjects with a history of radiation pneumonitis which has resolved are eligible.
  • Positive for human immunodeficiency virus (HIV) infection.
  • Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer< 1000 cps/mL or 200 IU/mL), or cured Hepatitis C (negative HCV RNA test) may be enrolled.
  • History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis disease.
  • Subject who have had severe infection deemed clinically significant per investigator within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose administration.
  • Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy (e.g., anaphylaxis, hepatotoxicity, immune-mediated thrombocytopenia or anemia).
  • Subjects who experienced immunotherapy-related adverse events (irAE) grade ≥ 3, or who had to discontinue prior immunotherapy treatment due to irAEs of any grade.
  • Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
  • Any other serious underlying medical (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications.
  • Known history of hypersensitivity to any components of the IBI188 product.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • START Midwest

    Grand Rapids, Michigan, 49546

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Thomas Jefferson Univerity

    Philadelphia, Pennsylvania, 19107

  • START (South Texas Accelerated Research Therapeutics, LLC)

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1a 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 Malignant Tumors and Lymphomas

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

The study is composed of two stages: Part 1 Accelerated Titration Phase and Part 2 Dose Escalation Phase with initial fixed priming dose.

The starting dose for part 1 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 28 days.

Part 2 will have 4 dose cohorts(3mg/kg QW、10mg/kg QW、20mg/kg QW and 30mg/kg QW). Conventional 3+3 Dose Escalation will be adopted. DLT observation period is 28 days.

Being tested
IBI188

What participants receive

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

  • IBI188Biological

    The study is composed of two stages: Part 1 Accelerated Titration Phase and Part 2 Dose Escalation Phase with initial fixed priming dose.

    The starting dose for part 1 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 28 days.

    Part 2 will have 4 dose cohorts(3mg/kg QW、10mg/kg QW、20mg/kg QW and 30mg/kg QW). Conventional 3+3 Dose Escalation will be adopted. DLT observation period is 28 days.

Study groups in NCT03763149
Study groupRoleWhat they receive
IBI188ExperimentalPart 1: Accelerated Titration Phase 0.1 mg/kg IV; QW 0.3 mg/kg IV QW; 1 mg/kg IV QW Part 2 : Dose Escalation Phase with initial fixed priming dose Priming dose of 1mg/kg on C1D1 followed by 3 mg/kg IV QW; 10 mg/kg IV QW; 20 mg/kg IV QW; 30 mg/kg IV QW.
Receives: Biological: IBI188

What is being measured

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

  1. Number of patients with AEs and SAEs

    To evaluate the safety and tolerability of IBI188 [Adverse events (AEs), Serious Adverse Events (SAE) ]

    Measured: 2 years

Secondary outcomes (4)

  1. Pharmacokinetics: AUC

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

    Measured: up to 2 years after enrollment

  2. Pharmacokinetics: Cmax

    Maximum concentration(Cmax) of the drug after administration

    Measured: up to 2 years after enrollment

  3. Immunogenicity: Percentage of ADA positive patients

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

    Measured: up to 2 years after enrollment

  4. 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 iRECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma.

    Measured: up to 2 years after enrollment

Timeline

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

  1. First posted4 Dec 2018
  2. Study start19 Feb 2019
  3. Primary completion29 Mar 2021
  4. Study completion29 Mar 2021

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03763149
Sponsor's protocol ID
CIBI188A102
Status last verified
Nov 2021
First submitted
18 Nov 2018
Last updated
6 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 4 sites in United States.

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 14 inclusion and 21 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 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

Number of patients with AEs and SAEs (time frame: 2 years). 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 NCT03763149.

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 6 Dec 2021.

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