CClinicalTrials.gg
Status unknownNCT04854681Updated Apr 22, 2021

Phase 1 Trial of the TQB2928 Injection in Patients With Advanced Cancers

A Phase 1 interventional study of TQB2928 Injection in Advanced Solid Tumors and Hematological Malignancies, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-22.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

TQB2928 is a promising new molecular entity that mediates blockade of CD47 and SIRPα and enhances the phagocytosis of cancer cells by macrophages. In preclinical in vivo models, TQB2928 was active against a wide range of solid tumors and hematologic malignancies. This is the first-in-human phase 1 trial of TQB2928 in patients with advanced solid tumors and hematological malignancies.

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Conditions studied

  • Advanced Solid Tumors and Hematological Malignancies
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.

      1. Histologically or cytologically confirmed, locally advanced unresectable or metastatic solid tumors, or hematological malignancies, or lymphoma.
      1. Solid tumors or hematological malignancies that failed from standard therapy, or lymphoma patients who have had at least two regimens of systemic therapy failures, or who refused other systemic therapy.
      1. At least 1 measurable lesion according to tumor-appropriate response criteria.
      1. Must have adequate organ and bone marrow function. 6. Resolved acute effects of any prior therapy to baseline severity or Grade ≤1 per CTCAE v5.0 except for AEs not constituting a safety risk by investigator judgment.
      1. Serum pregnancy test (for females of childbearing potential) negative within 7 days before enrollment.
      1. Male and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective method(s) of contraception throughout the study and for at least 90 days (180 days if required by local regulation) after the last dose of assigned treatment.
      1. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Exclusion criteria

Exclusion Criteria:

    1. Patients with known symptomatic brain metastases requiring steroids. 2. Concurrent secondary malignancy. 3. Uncontrolled pleural effusion or pericardial effusion with clinical significance and requiring repeated drainage as assessed by the Investigators.

      1. Prior treatment with monospecific or bispecific antibodies or fusion proteins targeting CD47 or signal regulatory protein alpha (SIRPα).
      1. Therapeutic or experimental monoclonal antibodies within 28 days prior to enrollment.
      1. Immunosuppressive regimens involving systemic corticosteroids (except \<10 mg daily prednisone equivalent) within 14 days before the first dose of study treatment.
      1. Prior allogeneic hematopoietic stem cell transplant. 8. Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment.
      1. RBC transfusion dependence, defined as requiring more than 2 units of RBC transfusions during the 4-week period prior to screening. RBC transfusions are permitted during screening and prior to enrollment to meet the hemoglobin inclusion criteria.
      1. Vaccination within 4 weeks prior to enrollment except for administration of inactivated vaccines (for example, inactivated influenza vaccines) 11. Active and clinically significant bacterial, fungal or viral infection including tuberculosis, hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
      1. History of hemolytic anemia or Evans syndrome within 3 months. 13. Autoimmune hemolytic anemia (AIHA) assessed by Positive Direct Antiglobulin Test (DAT).
      1. Autoimmune disorders (e.g., Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus) and other diseases that compromise or impair the immune system.
      1. Unstable or serious concurrent medical conditions in the previous 6 months. 16. Significant medical diseases or conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.
      1. Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    TQB2928 injection

    Dose Escalation: intravenous (IV) infusion of TQB2928 as monotherapy

    Drug: TQB2928 Injection

Interventions

  • DrugTQB2928 Injection

    4 weekly IV infusions (Days 1, 8, 15, and 22) of TQB2928 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal.

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What researchers measure

Primary outcomes

  1. Dose Limiting Toxicities (DLTs)

    DLTs will be assessed during the first 28 days of treatment for dose-escalation and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (28 days) of treatment.

    Time frame: During the first 28 days

  2. Maximum tolerated dose (MTD)

    MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).

    Time frame: During the first 28 days

Secondary outcomes

  1. Number of patients with adverse events (AEs) and serious adverse events (SAEs)

    Assessed by CTCAE v5.0

    Time frame: From the time of informed consent signed through 90 days after the last dose

  2. Pharmacokinetics: Cmax

    Maximum observed concentration (Cmax) of TQB2928 after administration

    Time frame: From the time of informed consent signed through 90 days after the last dose

  3. Pharmacokinetics: Cmin

    Minimum observed concentration (Cmin) of TQB2928 at steady state

    Time frame: From the time of informed consent signed through 90 days after the last dose

  4. Pharmacokinetics: Tmax

    Time to maximum concentration (Tmax)

    Time frame: From the time of informed consent signed through 90 days after the last dose

  5. Pharmacokinetics: AUC

    The area under the curve (AUC) of serum concentration of TQB2928

    Time frame: From the time of informed consent signed through 90 days after the last dose

  6. Pharmacokinetics: T1/2

    Terminal half-life (T1/2)

    Time frame: From the time of informed consent signed through 90 days after the last dose

  7. Percentage of ADA positive patients

    Number of patients who develop detectable anti-drug antibody (ADA), and percentage of ADA positive patients will be calculated to evaluate immunogenicity of TQB2928.

    Time frame: From the time of informed consent signed through 90 days after the last dose

  8. Objective Response Rate (ORR)

    Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by iRECIST v1.1 criteria for solid tumors, Lugano2014 criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma, and AML IWG 2003 response criteria for acute myeloid leukemia (AML).

    Time frame: up to 2 years

  9. Disease control rate (DCR)

    Defined as the proportion of subjects with CR, PR, or SD.

    Time frame: up to 2 years

  10. Duration of Response (DOR)

    Defined as the time from first documented response to documented disease progression.

    Time frame: up to 2 years

  11. Progression-free survival (PFS)

    Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.

    Time frame: up to 2 years

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04854681
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Apr 22, 2021
Start date
Aug 1, 2021 (estimated)
Primary completion
Jul 1, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Apr 22, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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