Study of SC-102 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin ConjuStar Biologics Co., Ltd.
About this trial
This study will evaluate the safety, PK profile, and anti-cancer efficacy of SC-102 in subjects with advanced 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).
Aged 18 to 75 years at the time of signature of the ICF, without gender limitation.
Eastern Cooperative Oncology Group (ECOG) Performance Status score 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 cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, papillary carcinoma of the thyroid gland, carcinoma in situ of the duct in situ, or other malignant tumors that have survived without disease for more than 5 years.
Any anticancer treatment, including experimental treatments, within 4 weeks before the first dose of the study drug.
Radiotherapy to >30% of the bone marrow or extensive radiotherapy within 4 weeks, or local radiotherapy (e.g., radiation therapy to the thoracic spine and ribs) within 7 days, prior to the first dose of the study drug.
Uncontrolled central nervous system metastases.
Trial design
Design model
Sequential
Treatments tested in this trial
SC-102
DrugSC-102 is a peptide drug conjugate (PDC) consisting an EphA2-targeting peptide, a tubulin inhibitor, and a protease-hydrolyzable linker.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: SC-102 for once weeklyExperimental treatment 1 intervention
Group B: SC-102 for once biweeklyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants receiving SC-102 treatment with treatment-emergent adverse events (escalation study)
Safety reported as incidence of treatment-emergent adverse events
Time frame
From Cycle 1 Day 1 (each cycle is 28 days) until 30 days post last dose2
Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities from SC-102 treatment (escalation study)
Maximum Tolerated Dose (MTD)
Time frame
At the end of Cycle 1 (each cycle is 28 days)3
Objective response rate by RECIST 1.1 in participants with solid tumors receiving SC-102 treatment (expansion study)
Defined as the percentage of subjects who experience a best response of either complete response (CR) or partial response (PR).
Time frame
From Cycle 1 Day 1 (each cycle is 28 days) until the date of first documented progression, death from any cause, start treatment of new anti-cancer agent(s), loss of follow-up, or withdrawal of consent, which ever came first, assessed up to 2 yearsSecondary outcomes
1
Maximum plasma concentration (Cmax) of SC-102 and monomethyl auristatin E (MMAE)
Plasma concentrations of SC-102 and MMAE from all participants receiving SC-102 treatment
Time frame
From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years2
Minimum plasma concentration (Cmin) of SC-102 and monomethyl auristatin E (MMAE)
Plasma concentrations of SC-102 and MMAE from all participants receiving SC-102 treatment
Time frame
From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years3
Area under the plasma concentration-time curve (AUC) of SC-102 and monomethyl auristatin E (MMAE)
Plasma concentrations of SC-102 and MMAE from all participants receiving SC-102 treatment
Time frame
From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 years4
Elimination half-life (t1/2) of SC-102 and monomethyl auristatin E (MMAE)
Plasma concentrations of SC-102 and MMAE from all participants receiving SC-102 treatment
Time frame
From Cycle 1 Day 1 through the end of treatment from any cause, assessed up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov