Clinical trial · Interventional
Clinical Trial of the TQB2928 Injection in Patients With Advanced Cancers
A Phase I Study of TQB2928 Injection in Patients With Advanced Cancers
NCT05192512CI-TRIAL-00056862unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
TQB2928 is a promising new molecular entity that mediates blockade of CD47 and SIRPα (Signal Regulatory Protein Alpha) and enhances the phagocytosis of cancer cells by macrophages. This is a study to evaluate the safety, tolerability and effectiveness of TQB2928 injection in subjects with advanced malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB2928 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB2928 injection
- description
- weekly intravenous (IV) infusions for four times (Days 1, 8, 15, and 22) of TQB2928 in each 28-day treatment cycle
- interventionNames
- Drug: TQB2928 injection
Primary outcomes (2)
- measure
- Dose Limiting Toxicity (DLT)
- timeFrame
- During the first 28 days
- description
- DLT 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.
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- During the first 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1 Male or female patient ≥18 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks; * 2 Must have adequate organ and bone marrow function; * 3 Pregnancy test (for females of childbearing potential) negative within 7 days before first dose. Male and female patients of childbearing potential and at risk for pregnancy must agree to use highly effective method(s) of contraception throughout the study and for at least 6 months after the last dose of assigned treatment; * 4 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; * 5 Histologically or cytologically confirmed, locally advanced unresectable or metastatic solid tumors, or hematological malignancies, or lymphoma; * 6 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; Exclusion Criteria: * 1 Patients with known symptomatic brain metastases * 2 Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years * 3 Uncontrolled pleural effusion or pericardial effusion with clinical significance and require repeated drainage as assessed by the Investigators * 4 Prior treatment with monospecific or bispecific antibodies or fusion proteins targeting CD47 or signal regulatory protein alpha (SIRPα) * 5 Therapeutic or experimental antibodies within 3 months prior to first dose * 6 Approved tyrosine kinase inhibitor (TKI) therapy within less than 5 half-lives prior to enrollment. * 7 Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 3 months prior to first dose; * 8 Liver abnormalities including hepatitis B (HBV) and hepatitis C (HCV). * 9 History of hemolytic anemia or Evans syndrome within 3 months. * 10 Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.