A Phase I/IIa Study of SYS6041 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
This trial is the first-in-human study of SYS6041, a multicenter, open-label, dose-escalation, dose-reassignment and cohort-expansion Phase I/IIa clinical study, which aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary antitumor efficacy of SYS6041 in participants with advanced solid tumors.
Eligibility criteria
Qualifiers
Aged >= 18 years.
The expected survival time is >=3 months.
Eastern Cooperative Oncology Group (ECOG) 0~1.
Willing to provide recent tumor tissue specimens for FRα testing.
Disqualifiers
Known severe allergic reaction to the study drug or any other components/excipients in the formulation.
Untreated (including those identified at baseline screening) or unstable parenchymal brain metastases, spinal metastases or spinal cord compression, carcinomatous meningitis.
History of other malignant tumors within 3 years, or concurrent active malignant tumors.
Prior treatment with ADCs carrying topoisomerase I inhibitor payloads.
Trial design
Treatments tested in this trial
- SYS6041
Treatment groups
260 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov