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Solid Malignancies or LymphomasPhase 1NCT05290597

A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas

A Phase 1 study testing IBI363 in people with Solid Malignancies or Lymphomas, run by Innovent Biologics (Suzhou) Co. Ltd. at 4 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI363 (study drug) in subjects with advanced, refractory solid malignancies or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Malignancies or Lymphomas
What is being tested?
IBI363
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesAustralia
Study dates
22 Aug 2022to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Male or female subjects, ≥ 18 years
  • Subjects with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; subjects with documented lymphomas
  • Subjects with a malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
  • Subjects who are refractory to or intolerant to existing therapy(ies) known to provide clinical benefit Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial.
  • Subjects with measurable or non-measurable disease according to RECIST v1.1 or standard criteria for lymphoma (Lugano 2014)
  • Subjects, both male and female, who are either not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug
  • Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol

Who cannot join

  • Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. Women of childbearing potential (WOCBP) or fertile men with WOCBP partner(s), not using and not willing to use a highly effective method of contraception.
  • Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
  • Subjects with:
  • Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable.
  • Active uncontrolled bleeding or a known bleeding diathesis.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Kate.Wilkinson1@health.nsw.gov.au

    Sydney, New South Wales, 2109

  • Westmead Hospital

    Sydney, New South Wales, 2145

  • Sydney Southwest Private Hospital

    Sydney, New South Wales, 2170

  • Cancer Care Wollongong

    Sydney, New South Wales, 2500

Other trials in Australia

About this study

This is a Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI363 (study drug) in subjects with advanced, refractory solid malignancies or lymphomas.

Being tested
IBI363
Medical subject headings
Lymphoma

What participants receive

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

  • IBI363Biological

    a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.

Study groups in NCT05290597
Study groupRoleWhat they receive
IBI363ExperimentalSingle arm
Receives: Biological: IBI363

What is being measured

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

  1. Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)

    An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.

    Measured: up to 90 days after the last administration

  2. Number of participants with abnormality in vital signs

    Blood pressure, pulse, respiratory rate, and temperature will be assessed.

    Measured: up to 90 days after the last administration

  3. Number of participants with abnormality in hematology parameters

    Blood samples will be collected to evaluate hemoglobin, mean corpuscular volume (MCV), white blood cell (WBC) count, platelets, 5-part differential white cell count, mean platelet volume and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT)

    Measured: up to 90 days after the last administration

  4. Number of participants with abnormality in clinical chemistry parameters

    Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.

    Measured: up to 90 days after the last administration

  5. Number of participants with abnormality in routine urinalysis parameters

    Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.

    Measured: up to 90 days after the last administration

  6. Number of participants with abnormality in ECG parameters

    12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.

    Measured: up to 90 days after the last administration

  7. Number of dose-limiting toxicity (DLT)

    Incidence of dose-limiting toxicity (DLT) events

    Measured: 28 days during the first 4-week cycle

Secondary outcomes (13)

  1. maximum concentration (Cmax)

    PK parameters to be evaluated for IBI363 including maximum concentration (Cmax) will be determined when appropriate.

    Measured: Up to 2 years

  2. area under the curve (AUC)

    PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate.

    Measured: Up to 2 years

  3. clearance (CL)

    PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate.

    Measured: Up to 2 years

  4. half-life (t1/2) of IBI363

    PK parameters to be evaluated for IBI363 including volume of distribution (V) will be determined when appropriate.

    Measured: Up to 2 years

  5. Objective response rate (ORR)

    To evaluate the preliminary antitumor activity of IBI363

    Measured: Up to 2 years

  6. time to response (TTR)

    To evaluate the preliminary antitumor activity of IBI363

    Measured: Up to 2 years

  7. duration of response (DoR)

    To evaluate the preliminary antitumor activity of IBI363

    Measured: Up to 2 years

  8. disease control rate (DCR)

    To evaluate the preliminary antitumor activity of IBI363

    Measured: Up to 2 years

  9. progression-free survival (PFS)

    To evaluate the preliminary antitumor activity of IBI363

    Measured: Up to 2 years

  10. 6-month and 1-year PFS rate per RECIST v1.1 for subjects with solid tumors, and per Lugano 2014 for subjects with lymphomas

    To evaluate the preliminary antitumor activity of IBI363

    Measured: Up to 2 years

  11. Overall survival (OS)

    To evaluate the preliminary antitumor activity of IBI363

    Measured: through study completion, an average of 1 year

  12. survival rates (6-month and 1-year)

    To evaluate the preliminary antitumor activity of IBI363

    Measured: Up to 2 years

  13. The incidence of ADA and NAb of IBI363

    Each subject will be tested for anti-drug (IBI363) antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb).

    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 posted22 Mar 2022
  2. Study start22 Aug 2022
  3. Primary completion28 Jan 2026
  4. Study completion31 Dec 2026 (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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05290597
Sponsor's protocol ID
CIBI363A101
Status last verified
Mar 2026
First submitted
9 Jan 2022
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI363 in people with Solid Malignancies or Lymphomas, run by Innovent Biologics (Suzhou) Co. Ltd. at 4 sites in Australia.

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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. 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 Australia. 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?

This study is still under way. Results are not available in the source record yet.

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?

Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs) (time frame: up to 90 days after the last administration). The study lists 7 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 NCT05290597.

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 5 Mar 2026.

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