Last reviewed · How we verify
NCT07043751
A Phase I Clinical Trial Evaluating the Tolerance, Pharmacokinetics and Preliminary Efficacy of Injection TQB6411 in Subjects With Advanced Malignant Tumors
Phase 1 trial testing TQB6411 injection in Advanced Malignant Tumors in 216 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 216 |
| Start date | 15 July 2025 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 June 2028 |
| Sites | 19 locations across China |
Drugs / interventions tested
- TQB6411 injection — full drug profile →
Conditions studied
- Advanced Malignant Tumors — all drugs for Advanced Malignant Tumors →
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Advanced Malignant Tumors. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Dose-limiting toxicity
Time frame: Up to24 months
Dosage-limiting toxicity refers to any of the following events that researchers and sponsors believe to be related to the treatment of TQB6411 for injection (including positively related, likely related, and possible related) (except for special instructions, the degree of adverse events is evaluated in accordance with National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse E -
Maximum Tolerated Dose
Time frame: Up to24 months
Defined as the highest dose in less than 33% of subjects with dose-limiting toxicity (DLT). -
Phase II recommended dose
Time frame: Up to24 months
The recommended dose for subsequent phase II studies will be determined based on Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), preliminary efficacy and safety. -
Rate and severity of adverse events
Time frame: Up to24 months
Rate and severity of adverse events
Sponsor's own description
TQB6411 for injection is an antibody-conjugated drug (ADC) targeting EGFR/c-Met. After injecting blood intravenously, the antibody part of this product binds to the surface of EGFR and c-Met on tumor cells to block the activation of EGFR and c-Met signaling pathways. The ADC is enzymatically transported to the lysosome. The linker releases toxins after enzyme cleavage, resulting in DNA damage and cell death. TQB6411 for injection is intended for the treatment of advanced malignant tumors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07043751
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Malignant Tumors
Currently open trials in the same condition.
- NCT07038005 — A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors · Phase 1 · recruiting
- NCT07016490 — A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors · Phase 1 · recruiting
- NCT06877650 — First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors · Phase 1, PHASE2 · recruiting
- NCT06764771 — A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors · Phase 1 · active not recruiting
- NCT06223841 — A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors · Phase 1, PHASE2 · recruiting
Other Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07052097 — Clinical Trial of TQC2938 Injection in Patients With Seasonal Allergic Rhinitis · Phase 2 · completed
- NCT06929195 — Clinical Trial to Evaluate the Tolerance of TQB2210 Injection · Phase 1 · completed
- NCT06542614 — Treatment of Moderate to Severe Plaque Psoriasis · Phase 2 · completed
- NCT06451640 — A Extension Clinical Study of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps · Phase 2 · completed
- NCT06438783 — TQB2928 Injection Combined Anlotinib Hydrochloride Capsule in Recurrent/Metastatic Osteosarcoma and Other Solid Tumors · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07043751 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Last refreshed: 18 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07043751.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing