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Advanced MalignanciesPhase 1NCT04085185

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors

A Phase 1 study testing IBI110 and IBI110+ Sintilimab in people with Advanced Malignancies, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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 of IBI110 in subjects with advanced malignancies. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignancies
What is being tested?
IBI110 and IBI110+ Sintilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
1 siteChina
Study dates
4 Dec 2019to 30 Jun 2024
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to understand and willing to sign the ICF.
  • Adults 18 years of age or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy at least 12 weeks.
  • Adequate organ and bone marrow function.
  • 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.
  • Measurable disease according to RECIST Version 1.1 in solid tumor.
  • 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

  • Previous exposure to any anti-lag-3 antibody.
  • Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.
  • Any investigational drugs received within 4 weeks prior to the first study treatment.
  • Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
  • Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.
  • Medication requiring long-term systemic hormones or any other immunosuppression therapy.
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  • Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy.
  • There were unrecovered toxicity (excluding hair loss or fatigue) according to NCI CTCAE v5.0 induced by previous antitumor therapy (24 weeks before the first dose of study), and there were unrecovered immune-related adverse events (irAE) associated with immunotherapy.
  • Previous immunotherapy, such as anti-PD-1 / anti-PD-L1 antibody or anti-CTLA4 antibody, was discontinued due to the presence of > grade 3 irAE.
  • Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
  • History of autoimmune disease , present active autoimmune disease or inflammatory diseases
  • Present or history of pulmonary diseases such as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pulmonary fibrosis, active pulmonary infection, severely impaired pulmonary function.
  • Positive human immunodeficiency virus (HIV) test.
  • Active hepatitis B or C, or tuberculosis.
  • History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 16. History of gastrointestinal perforation and/or fistula at 6 months prior to study inclusion.
  • 17.Hydrothorax, ascites, and pericardial effusion with clinical symptoms requiring drainage.
  • 18.Known history of hypersensitivity to any components of the IBI110 or Sintilimab.
  • 19.Uncontrolled complications of disease.
  • 20.Other acute or chronic illness, mental illness, or abnormal laboratory test values that may increase the risk of study participation or administration of study drugs, or interfere with the interpretation of study results.
  • 21.History of other primary malignancies. 22. Pregnant or nursing females.

Trial locations and contacts

1 site in 1 country.

Qian Qu, Bachelor contact

86-18501735865

qian.wu@innoventbio.com

Caicun Zhou, M.D contact

+86 21 65115006

caicunzhoudr@163.com

China1 site, 1 recruiting

  • Shanghai Pulmonary Hospital

    Shanghai

    Caicun Zhou, 021-65115006, caicunzhoudr@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI110 in subjects with advanced malignancies.

Being tested
IBI110, IBI110+ Sintilimab

What participants receive

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

  • IBI110Drug

    Several dose levels will be evaluated for IBI110 administered as a single agent and in combination with Sintilimab. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI110 may receive combination treatment with IBI110 plus Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.

  • IBI110Drug

    IBI110 will be given with RP2D. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

  • IBI110+ SintilimabDrug

    IBI110: Several dose levels will be evaluated for IBI110 in combination with Sintilimab. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

    Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI110. Combination treatment may continue until disease progression or loss of clinical benefit.

  • IBI110+ SintilimabDrug

    IBI110: IBI110 in combination with Sintilimab will be given with RP2D. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

    Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI110. Combination treatment may continue until disease progression or loss of clinical benefit.

Study groups in NCT04085185
Study groupRoleWhat they receive
Phase Ia Dose-Escalation Stage:IBI110ExperimentalParticipants will be treated with escalating doses of IBI110 to determine the MTD.
Receives: Drug: IBI110
Phase Ia Expansion Stage:IBI110ExperimentalParticipants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in different cancer types.
Receives: Drug: IBI110
Phase Ib Dose-Escalation Stage:IBI110+ SintilimabExperimentalParticipants will be treated with escalating doses of IBI110 in combination with a fixed dose of Sintilimab to determine the MTD.
Receives: Drug: IBI110+ Sintilimab
Phase Ib Expansion Stage:IBI110+ SintilimabExperimentalParticipants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in combination with Sintilimab in different cancer types.
Receives: Drug: IBI110+ Sintilimab

What is being measured

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

  1. Number of subjects with AEs and SAEs

    To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab [Adverse events (AEs), Serious Adverse Events (SAEs) ]

    Measured: up to 2 years after enrollment

  2. Percentage of Participants with Dose-Limiting Toxicities (DLTs)

    To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab.

    Measured: From Baseline to the end of Cycle 1

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 subjects

    Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI110.

    Measured: up to 2 years after enrollment

  4. Preliminary anti-tumor activity of IBI110 (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: 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 posted11 Sep 2019
  2. Study start4 Dec 2019
  3. Primary completion15 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

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
268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04085185
Sponsor's protocol ID
CIBI110A101
Status last verified
Sep 2022
First submitted
9 Sep 2019
Last updated
14 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang Q, Xiong A, Mao C, Wang W, Cui J, Fang J, Zhuang W, Yang K, Zuo W, Yang J, Ye L, Zhang Z, Sheng Z, Liu Z, Wang D, Du X, Yi T, Long S, Xu N, Zhou C. Efficacy and safety of anti-LAG-3 IBI110 in combination with sintilimab and chemotherapy for advanced squamous non-small cell lung cancer: a randomized phase II study. Cancer Immunol Immunother. 2026 Jan 27;75(2):56. doi: 10.1007/s00262-026-04299-x.

    PubMed 41591537

  • Mao C, Xiong A, Qian J, Wang W, Liu Y, Zhang T, Wu Z, Ni H, Lu J, Long S, Zhao L, Chen Y, Zhou C, Xu N. Dual inhibition of LAG-3 and PD-1 with IBI110 and sintilimab in advanced solid tumors: the first-in-human phase Ia/Ib study. J Hematol Oncol. 2024 Dec 31;17(1):132. doi: 10.1186/s13045-024-01651-5.

    PubMed 39736787

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI110 and IBI110+ Sintilimab 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 8 inclusion and 20 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 14 Sep 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?

Results are not available in the source record.

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

Contact Qian Qu, Bachelor (86-18501735865, qian.wu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with AEs and SAEs (time frame: up to 2 years after enrollment). 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 NCT04085185, which also lists 2 linked publications.

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 14 Sep 2022.

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