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Trials
Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors

trialsTrialActive

Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors

A phase 1/2 trial of SYS6045 in advanced solid tumours, run by CSPC Megalith Biopharmaceutical Co.,Ltd., active and no longer recruiting.

Overview Connected2

Overview

Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors is a phase 1/2 interventional study registered as NCT07122063 by CSPC Megalith Biopharmaceutical Co.,Ltd., with 266 participants enrolled, started 2025-08-11 and due to reach its primary completion in 2027-07-30. Interventions recorded: SYS6045.

Setting

A Multicenter, Open-Label Phase I/II Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors

Phase

Phase 1/2

Sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Registry

Started

2025-08-11

Enrolled

266 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

companies

CSPC Pharmaceutical Group

Evidence strength20/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 1/2+8
266 enrolled+12
No structured primary endpoint0
Result: active0
No independent replication recorded0

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-16 · Jude Gomila · Registry trials wave 6 and products wave 7 · diff · file

Sources & links

ClinicalTrials.gov NCT07122063

Data

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Metastatic cancer (cancer that has spread)

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