SB17170 Phase 1 Clinical Trial in Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorSPARK Biopharma
About this trial
Phase 1 Open-label, multicenter, dose escalation, dose expansion study
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A patient with a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors.
A person who has failed the known standard of care or has developed resistance to the standard of care and no longer has applicable standard of care
A patient with at least one measurable lesion according to the RECIST v1.1 criteria.
A person with Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
Disqualifiers
A patient who has received drugs targeting High Mobility Group Box 1 (HMGB1).
A patient who has received or is undergoing chemotherapy (including chemotherapy, radiation therapy, immunotherapy, hormone therapy, targeted therapy, biological products, and tumor embolization) within 28 days from the first administration date of the investigational drug.
A person who needs to take contraindicated drugs or is expected to take them during the study period.
Trial design
Design model
Sequential
Treatments tested in this trial
SB17170
DrugSB17170 capsules, Oral administration 21days/cycle
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Cohort 1Other 1 intervention
Group B: Cohort 2Other 1 intervention
Group C: Cohort 3Other 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of SB17170
Evaluate DLT to estimate the maximum tolerated dose (MTD), and determine a recommended Phase 2 dose (RP2D).
Time frame
At the end of Cycle 1 (each cycle is 21 days)Secondary outcomes
1
Pharmacokinetic(Cmax)
Peak Plasma Concentration
Time frame
At Day1 and D21 of Cycle 1 (each cycle is 21 days)2
Pharmacokinetic(Tmax)
Time to Peak Plasma Concentration
Time frame
At Day1 and D21 of Cycle 1 (each cycle is 21 days)3
Pharmacokinetic(AUC)
Area under the plasma concentration versus time curve
Time frame
At Day1 and D21 of Cycle 1 (each cycle is 21 days)4
The anti-tumor activity with RECIST v1.1
CT/MRI every 6 weeks
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 100weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov