A Study of DXC018 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou DAC Biotechnology Co., Ltd.
About this trial
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC018 in participants with Advanced Solid Tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign the informed consent form and comply with the protocol requirements.
Male or female, age ≥18 years old and ≤75 years old.
Participants with advanced malignancy confirmed by histology or cytology.
Participants with locally advanced or metastatic solid tumors that cannot be surgically removed who have experienced disease progression after standard therapy, or are currently ineligible for standard therapy, or in lack of standard treatment. (Standard therapy is defined as per domestic consensus guidelines [where applicable] or treatment aligned with current domestic medical practice).
Disqualifiers
Participants with primary malignancies in other organs currently. Participants may be enrolled in the following scenarios: participants with healed basal cell or squamous cell skin cancer, cervical carcinoma in situ, papillary thyroid cancer, ductal carcinoma in situ of the breast.Or participants with other malignancies achieving over 5-year disease-free survival.
Serum pregnancy test: Positive or breastfeeding woman.
Received systemic anti-tumor therapy or investigational drug without washout. Received major surgeries treatment within 28 days prior to the first dose. Received local radiotherapy within 14 days prior to the first dose.
History of solid organ transplantation.
Trial design
Design model
Single group
Treatments tested in this trial
DXC018
DrugCohort A: Once every 2 weeks (Q2W) with a cycle length of 14 days. Cohort B: Once every 3 weeks (Q3W) with a cycle length of 21 days.
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: DXC018Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level
Time frame
28 days2
Maximum tolerated dose
Time frame
After first infusion of study drug, through study with an average completion of 2 years3
Recommended Phase II dose
Time frame
After first infusion of study drug, through study with an average completion of 2 years4
Number of participants with adverse events (AEs)
Time frame
After first infusion of study drug, through study with an average completion of 2 yearsSecondary outcomes
1
Maximum observed serum or plasma concentration (Cmax)
Time frame
After first infusion of study drug, through study with an average completion of 2 years2
Anti-drug antibodies (ADA)
Time frame
After first infusion of study drug, through study with an average completion of 2 years3
Measurement of objective response rate (ORR) per RECIST 1.1
Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years4
Progression Free Survival (PFS)
Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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