SMP-3124LP in Adults With Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSumitomo Pharma America, Inc.
About this trial
An Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid Tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Platinum-resistant ovarian cancer
Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)
Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy
Triple negative breast cancer - ER- and PR-negative with HER2 negative
Disqualifiers
Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
Patient has a known allergy or sensitivity to any component of SMP-3124LP, including the inactive ingredients
Patient has received treatment with systemic anticancer therapy, radiotherapy, or investigational therapy within 14 days prior to Study Cycle 1 Day 1. (Palliative radiotherapy with a limited field of radiation within 2 weeks will be permitted.)
Patient has undergone a major surgical procedure ≤ 28 days, or minor surgical procedure ≤ 7 days, prior to Cycle 1 Day 1
Trial design
Design model
Parallel
Treatments tested in this trial
SMP3124LP
DrugLiposomal encapsulation formulation of SMP-3124
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Part 1 - Dose Escalation & Dose OptimizationExperimental treatment 1 intervention
Group B: Part 2 - Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)
Time frame
28 days2
Number of Participants With Adverse Events and Serious Adverse Events
Time frame
6 months3
Determine the Objective Response Rate (ORR)
Time frame
6 monthsSecondary outcomes
1
The maximum concentration (Cmax) of SMP-3124 and SMP-3124LP
Time frame
6 months2
The area under the curve (AUC) of SMP-3124 and SMP-3124LP
Time frame
6 months3
The duration of response (DOR) assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov