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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SYS6041
DrugFarletuzumab-exatecan antibody-drug conjugate targeting human FRα
Treatment groups
260 Participants
are divided into 1 treatment groupGroup A: SYS6041Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limiting toxicity (DLT)
Incidence of DLT (Applicable only to the Phase I dose-escalation stage)
Time frame
21 days2
ORR
ORR assessed by investigators per RECIST 1.1
Time frame
Through study completion，up to 2 years.Secondary outcomes
1
Number of participants with Adverse events (AEs)
Safety assessments
Time frame
Up to 2 years2
DCR
During follow-up
Time frame
Up to 2 years3
Progression-free survival（PFS）
During follow-up
Time frame
Up to 2 years4
Overall survival (OS)
During follow-up
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov