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Advanced Malignant TumorsPhase 1NCT04708210

Study of the Efficacy and Safety of IBI319 in Patients With Advanced Malignant Tumors

A Phase 1 study testing IBI319 in people with Advanced Malignant Tumors, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

An open-label, multicenter, phase Ia/Ib study to evaluate the safety, tolerance and preliminary efficacy of IBI319 in patients with advanced malignant tumors Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Tumors
What is being tested?
IBI319
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteChina
Study dates
28 Apr 2021to 21 Jun 2023
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

  • Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
  • Patients with advanced solid tumors or hematological malignancies who had failed standard treatment.
  • Male or female subjects ≥18 years and ≤75 years.
  • At least one measurable lesion (per RECIST version 1.1) in solid tumor patients and at least one measurable and hyper metabolic in 18F-FDG lesion (per Lugano2014) in lymphoma patients
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
  • Subjects with life expectancy of ≥ 12 weeks.
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  • Subjects must have adequate organ function (liver, kidney function and hematopoietic function tests) prior IBI319 administration
  • Absolute neutrophil count (ANC) ≥1.5 x10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9 g / dL (whole blood or component transfusion within 7 days before 1st dose of study drug is prohibited)
  • Renal function tests: an estimated glomerular filtration rate (eGFR) ≥ 50 mL/min
  • Liver function tests alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN, for patients with known liver cancer or liver metastases, AST and ALT ≤ 5 x ULN
  • Total bilirubin (TBil) ≤1.5 x ULN; If Gilbert's Syndrome may have Bilirubin> 2 x ULN
  • Coagulation tests: APTT ≤ 1.5 x ULN and INR ≤1.5 x ULN
  • Subjects (males and females) of childbearing potential should be willing to use reliable contraception methods that are deemed effective by the investigator from visit 1 through 180 days following the last dose of study drug.

Who cannot join

  • Legal incapacity or limited legal capacity.
  • Pregnancy, lactation, breastfeeding.
  • Prior treatment with an anti-CD137, anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug (except for Ib cohort A and B).
  • NSCLC patients with EGFR mutations or ALK gene rearrangements.
  • Colorectal cancer patients with KRAS mutation / BRAF mutation / HER2 overexpression.
  • Concurrent anticancer treatment or use of other investigational product within 4 weeks before start of trial treatment; major surgery within 4 weeks before start of trial treatment (excluding prior diagnostic biopsy).
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  • Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE ≤ grade 1 or baseline with the exception of alopecia.
  • Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
  • Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
  • Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
  • -

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong Provincial People's Hospital

    Guangdong

Other trials in China

About this study

Official title: An Open-label, Multicenter, Phase Ia/Ib Study to Evaluate the Safety, Tolerance and Preliminary Efficacy of IBI319 in Patients With Advanced Malignant Tumors

An open-label, multicenter, phase Ia/Ib study to evaluate the safety, tolerance and preliminary efficacy of IBI319 in patients with advanced malignant tumors

Being tested
IBI319

What participants receive

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

  • IBI319Drug

    Iv infusion day 1 of every 14 or 21 days in Phase Ia until disease progression or loss of clinical benefit.

Study groups in NCT04708210
Study groupRoleWhat they receive
Phase Ia Dose-Escalation Stage: IBI319ExperimentalNot described
Receives: Drug: IBI319

What is being measured

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

  1. Number of patients with DLT, AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE), discontinuation of study drug due to AE, dose-limiting toxicity (DLT) assessed by CTCAE v5.0

    Measured: up to 2 years

Secondary outcomes (5)

  1. Overall response rate (ORR) based on RECIST v1.1 criteria and Lugano 2014 criteria.

    Measured: up to 2 years

  2. Progression-free survival (PFS) based on RECIST v1.1 criteria and Lugano 2014 criteria

    Measured: up to 2 years

  3. Overall Survival (OS) based on RECIST v1.1 criteria and Lugano 2014 criteria

    Measured: up to 2 years

  4. Time To Response(TTR) based on RECIST v1.1 criteria and Lugano 2014 criteria

    Measured: up to 2 years

  5. Duration of Response(DOR) based on RECIST v1.1 criteria and Lugano 2014 criteria

    Measured: up to 2 years

Timeline

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

  1. First posted13 Jan 2021
  2. Study start28 Apr 2021
  3. Primary completion21 Dec 2022 (estimated)
  4. Study completion21 Jun 2023 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04708210
Sponsor's protocol ID
CIBI319A101
Status last verified
Oct 2022
First submitted
7 Jan 2021
Last updated
12 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 IBI319 in people with Advanced Malignant Tumors, 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 11 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 12 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?

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?

Number of patients with DLT, AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE), discontinuation of study drug due to AE, dose-limiting toxicity (DLT) assessed by CTCAE v5.0 (time frame: up to 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 NCT04708210.

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 12 Oct 2022.

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