Study SC-101 in Subjects With Advanced Malignancies
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTianjin ConjuStar Biologics Co., Ltd.
About this trial
This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).
18 to 80 years of age at the time of signature of the ICF, without gender limitation.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of ≥ 3 months as assessed by the investigator.
Disqualifiers
History of other malignancy(ies) within 3 years before signing the ICF, except for non-melanoma skin cancer, cervical carcinoma in situ, or other malignant tumors that are considered to have been cured.
Any anticancer therapy, including any investigational drug, within 2 weeks before the first dose of the study drug.
Uncontrolled central nervous system metastases.
Prior treatment with Nectin-4-targeting anti-cancer therapy.
Trial design
Design model
Single group
Treatments tested in this trial
SC-101
DrugAll subjects will receive a single intravenous (IV) infusion of SC-101 once weekly.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: SC-101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events (dose escalation phase)
Time frame
Up to 30 days after the last dose of study drug2
Objective response rate (dose expansion phase)
Defined as the percentage of subjects who experience a best response of either complete response (CR) or partial response (PR).
Time frame
Every 8 weeks (± 7 days)Secondary outcomes
1
Maximum plasma concentration (Cmax) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy
Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone
Time frame
From Cycle 1 Day 1 through end of treatment (EOT)2
Minimum plasma concentration (Cmin) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy
Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone
Time frame
From Cycle 1 Day 1 through end of treatment (EOT)3
Area under the plasma concentration-time curve (AUC) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy
Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone
Time frame
From Cycle 1 Day 1 through end of treatment (EOT)4
Elimination half-life (t1/2) of SC-101 and monomethyl auristatin E (MMAE) when given as monotherapy
Plasma concentrations of SC-101 and MMAE from all participants taking SC-101 alone
Time frame
From Cycle 1 Day 1 through end of treatment (EOT)Sponsors and contacts
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Source ClinicalTrials.gov