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Advanced Malignant TumorsPhase 1/2NCT04980690

Clinical Trial of IBC0966 in Patients With Advanced Malignant Tumors

A Phase 1/2 study testing IBC0966 in people with Advanced Malignant Tumors, run by SUNHO（China）BioPharmaceutical 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 The sponsor has not verified this record for over two years, so it may be out of date.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 a phase I/IIa study to evaluate the safety, tolerability and efficacy of IBC0966 for the treatment of subjects 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?
IBC0966
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
1 siteChina
Study dates
31 Aug 2021to Dec 2025
Phase
Phase 1/2
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

  • Aged 18 to 75 years old male and female.
  • Phase I (including phase Ia and phase Ib) will enroll patients with advanced malignant tumors who have failed standard treatments.
  • Phase IIa Study-Group A: Recurrent or metastatic triple-negative breast cancer diagnosed by histopathology that has failed standard treatments. Triple-negative breast cancer is defined as estrogen receptor (ER), progesterone receptor (PR), and human epidermis Growth factor receptors (HER2) are all negative.
  • Phase IIa Study-Group B: Advanced/metastatic non-small cell lung cancer with no driver gene mutations that has failed standard treatment confirmed by histopathology.
  • Phase IIa Study-Group C: Recurrent or metastatic head and neck squamous cell carcinoma that failed standard treatments confirmed by histopathology: including nasopharyngeal carcinoma and non-nasopharyngeal head and neck squamous cell carcinoma.
  • Phase IIa study-Group D: Recurrent or metastatic peripheral T-cell lymphoma (PTCL) diagnosed by histopathology that failed standard treatment: Including non-specific PTCL, NK/T-cell lymphoma (nasal type), and angioimmunoblast Cellular T cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), subcutaneous panniculitis-like T cell lymphoma, enteropathic T cell lymphoma (EATL), and hepatosplenic T cell lymphoma (HSTL) Wait.
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  • According to RECIST 1.1 or Lugano 2014 standards, there is at least one measurable lesion, and the measurable lesion has not received local treatment (including local radiotherapy, ablation, and interventional therapy).
  • Agree to provide previously stored tumor tissue specimens or perform a biopsy to collect tumor lesion tissue and send it to the central laboratory for PD-L1 expression level detection and TMB detection.
  • ECOG performance status 0-2.
  • Laboratory examination should meet: ① Blood routine: hemoglobin (HGB) ≥100 g/L, white blood cell count (WBC) ≥3.0×10^9/L, neutrophil count (ANC) ≥1.5×10^9/L, platelet count ( PLT) ≥75×10^9/L; ②Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN, serum creatinine ( Cr)≤1.5×ULN or calculate the creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula method.
  • Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography.
  • Life expectancy ≥3 months.
  • Agree to use at least one medically approved contraceptive method during the trial period and at least 6 months after the last dose (female patients: such as intrauterine devices, contraceptives or condoms, etc.; male patients: such as condoms, abstinence, etc.). Female patients must be non-lactating.
  • Subjects must be fully informed of the content, process and possible risks and benefits of the research and sign the informed consent form. Good compliance, able to complete the study and follow-up.

Who cannot join

  • Known to have severe hypersensitivity to any monoclonal antibody (≥CTCAE grade 3).
  • Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1), excluding hair loss, pigmentation, and fatigue.
  • Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  • Received any live vaccines within 4 weeks before enrollment.
  • Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started.
  • Have a history of hemolytic disease, immune-mediated thrombocytopenia, or Evans syndrome within 3 months before enrollment. Currently suffering from active or suspicious autoimmune disease or a history of autoimmune disease within the past 2 years.
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  • Phase Ia and Ib: previous exposure to any CD47 antibody, SIRPα antibody or CD47/SIRPα recombinant protein, or previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 ( PD-L1) antibody.
  • Received any systemic anti-tumor therapy within 4 weeks before enrollment.
  • Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
  • Central nervous system metastases with clinical symptoms were found within 4 weeks before enrollment. Patients who have previously received treatment for brain or meningeal metastases, if clinical stability has been maintained for at least 2 months, and have stopped systemic hormone therapy (dose>10 mg/day prednisone or other curative hormones) for more than 4 weeks can be included.
  • Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
  • Past or present suffering from other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ).
  • Suffering from serious or poorly controlled diseases, including but not limited to: ① Myocardial infarction, arrhythmia, congestive heart failure, etc. that require treatment or intervention occurred within 3 months before enrollment. ②Human immunodeficiency virus (HIV) infection (HIV antibody positive); hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive and HBV DNA ≥500 IU/mL or ≥1×10^3 copies/mL) ; HCV antibody positive and HCV RNA positive. ③ Poorly controlled diabetes, hypertension, thyroid disease, etc.; ④Severe and uncontrollable lung diseases (severe infectious pneumonia, interstitial lung disease, etc.) (≥CTCAE grade 3); ⑤Uncontrolled serious Infection (≥CTCAE grade 3).
  • With any situations that the researcher considers inappropriate to participate in this research.

Trial locations and contacts

1 site in 1 country.

tie xu contact

18036618680

18036618680@163.com

China1 site, 1 recruiting

  • The Affiliated Tumor Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

    Qingyuan Zhang, 0451-86298800

    Recruiting

Other trials in China

About this study

Official title: A Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of IBC0966 in Patients With Advanced Malignant Tumors

This is a phase I/IIa study to evaluate the safety, tolerability and efficacy of IBC0966 for the treatment of subjects with advanced malignant tumors.

Read the detailed description

The study includes three phases: dose escalation (Phase Ia), dose extension (Phase Ib), and clinical exploration (Phase IIa).

First, the Phase Ia dose escalation will be carried out. After switching to the 3+3 escalation mode, the Phase Ib dose extension study can be carried out at the same time. After Phase Ia is completed and RP2D is obtained, Phase IIa clinical exploratory research can be carried out.

Being tested
IBC0966
Keywords
PD-L1, CD47, Advanced Malignant Tumors

What participants receive

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

  • IBC0966Biological

    IBC0966 is an investigational product.

Study groups in NCT04980690
Study groupRoleWhat they receive
Phase Ia - Dose escalation(Acceleration Stage)ExperimentalPhase Ia is an open, non-random, single-arm dose escalation design. Acceleration Stage: The initial increasing dose is 0.025 mg/kg, and the dose is increased in 100% increments. Each dose group will enroll 1 subject.
Receives: Biological: IBC0966
Phase Ia - Dose escalation(3+3 Stage)ExperimentalPhase Ia is an open, non-random, single-arm dose escalation design. 3+3 Stage: The dose is increased in 30%-50% increments between adjacent dose groups, and the increment is determined by the investigator and the sponsor based on the safety data obtained in the previous period.Each dose group will enroll 3 to 6 evaluable subjects (evaluable: at least complete the DLT observation period), and this period continues until the maximum tolerated dose (MTD) is reached.
Receives: Biological: IBC0966
Phase Ib - Dose extensionExperimentalPhase Ib is an open, non-random, single-arm, multi-center research design. When phase Ia is transformed into 3+3 stage, a certain dose group meets the conditions for increasing the next dose group (after the DLT observation period of the last subject in the dose group has passed, the safety assessment of the current dose group will be completed) , The dose extension study of this dose group can be carried out, and 6 evaluable (evaluable: at least 2 cycles of dosing and observation) subjects with advanced malignant tumors who have failed standard treatments will be included in this dose group.
Receives: Biological: IBC0966
Phase IIa - Clinical Exploratory Stage(Group A)ExperimentalThe Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design. Group A: Recurrent or metastatic triple-negative breast cancer that failed standard treatment.
Receives: Biological: IBC0966
Phase IIa - Clinical Exploratory Stage(Group B)ExperimentalThe Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design. Group B: Locally advanced/metastatic non-small cell lung cancer without driver gene mutations that failed standard treatment.
Receives: Biological: IBC0966
Phase IIa - Clinical Exploratory Stage(Group C)ExperimentalThe Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design. Group C: Recurrent or metastatic head and neck squamous cell carcinoma that failed standard treatment.
Receives: Biological: IBC0966
Phase IIa - Clinical Exploratory Stage(Group D)ExperimentalThe Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design. Group D: Recurrent or metastatic peripheral T-cell lymphoma that failed standard treatment.
Receives: Biological: IBC0966

What is being measured

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

  1. Frequency of adverse events (AEs) and SAEs (Phase Ⅰ)

    To investigate the safety characteristics.

    Measured: 3 months after end event visit

  2. Dose limiting toxicities (DLTs) (Phase Ⅰ)

    To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).

    Measured: 28 days after first dose

  3. Objective response rate (ORR) in dose expansion (Phase Ⅱa)

    To explore the clinical effectiveness. Tumor response based on RECIST 1.1 or Lugano 2014.

    Measured: Baseline through up to 2 years or until disease progression

Secondary outcomes (17)

  1. Pharmacokinetic (PK) Cmax (Phase Ⅰ)

    PK parameters (Cmax) following single dose.

    Measured: Day1，2，3，7，14，21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years

  2. Pharmacokinetic (PK) Tmax (Phase Ⅰ)

    PK parameters (Tmax) following single dose.

    Measured: Day1，2，3，7，14，21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years

  3. Pharmacokinetic (PK) AUC 0-t (Phase Ⅰ)

    PK parameters (AUC 0-t ) following single dose.

    Measured: Day1，2，3，7，14，21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years

  4. Pharmacokinetic (PK) AUC 0-∞ (Phase Ⅰ)

    PK parameters (AUC 0-∞) following single dose.

    Measured: Day1，2，3，7，14，21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years

  5. Pharmacokinetic (PK) t1/2 (Phase Ⅰ)

    PK parameters (t1/2) following single dose.

    Measured: Day1，2，3，7，14，21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years

  6. Pharmacokinetic (PK) λz (Phase Ⅰ)

    PK parameters (λz) following single dose.

    Measured: Day1，2，3，7，14，21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years

  7. Pharmacokinetic (PK) Css,max (Phase Ⅰ)

    PK parameters (Css,max) following single dose.

    Measured: Day1，2，3，7，14，21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years

  8. Pharmacokinetic (PK) Css,min (Phase Ⅰ)

    PK parameters (Css,min) following single dose.

    Measured: Day1，2，3，7，14，21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years

  9. Pharmacokinetic (PK) AUCss (Phase Ⅰ)

    PK parameters (AUCss) following single dose.

    Measured: Day1，2，3，7，14，21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years

  10. Objective response rate (ORR) in dose escalation (Phase Ⅰ)

    Tumor response based on RECIST 1.1 or Lugano 2014.

    Measured: Baseline through up to 2 years or until disease progression

  11. Incidence of adverse events (AEs) and SAEs (Phase Ⅰ)

    To investigate the safety characteristics.

    Measured: 3 months after end event visit

  12. Immunogenicity of IBC0966 (Phase Ⅰ)

    The frequency of anti-drug antibodies (ADA) against IBC0966.(Phase Ⅰ)

    Measured: 3 months after end event visit

  13. Progression free survival (PFS) (Phase Ⅱa)

    PFS as assessed using RECIST 1.1 or Lugano 2014.

    Measured: Baseline through up to 2 years or until disease progression

  14. Overall survival (OS) (Phase Ⅱa)

    OS as assessed using RECIST 1.1 or Lugano 2014.

    Measured: Baseline through up to 2 years or until disease progression

  15. Disease control rate (DCR) (Phase Ⅱa)

    DCR as assessed using RECIST 1.1 or Lugano 2014.

    Measured: Baseline through up to 2 years or until disease progression

  16. Incidence of adverse events (AEs) and SAEs (Phase Ⅱa)

    To investigate the safety characteristics.

    Measured: 3 months after end event visit

  17. Immunogenicity of IBC0966 (Phase Ⅱa)

    The frequency of anti-drug antibodies (ADA) against IBC0966.(Phase Ⅱa)

    Measured: 3 months after end event visit

Timeline

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

  1. First posted28 Jul 2021
  2. Study start31 Aug 2021
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
228 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04980690
Sponsor's protocol ID
IBC0966-I/IIa
Status last verified
Mar 2023
First submitted
8 Jul 2021
Last updated
10 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IBC0966 in people with Advanced Malignant Tumors, run by SUNHO（China）BioPharmaceutical 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 14 inclusion and 14 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 10 Mar 2023. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 tie xu (18036618680, 18036618680@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events (AEs) and SAEs (Phase Ⅰ) (time frame: 3 months after end event visit). The study lists 3 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 NCT04980690.

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 10 Mar 2023.

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