SMP-3124LP in Adults With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT06526819
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SMP3124LP — DRUG
    Liposomal encapsulation formulation of SMP-3124

Study Details

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

Key Dates

Start date
Aug 14, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - Dose Escalation & Dose Optimization
    Patient to receive SMP-3124LP continuous IV infusion every 2 weeks (q2w) (Schedule 1). At the discretion of the Safety Review Committee (SRC), Schedule 2 - IV infusion every 3 weeks (q3w) - may be initiated for example, after a maximum tolerated dose (MTD) is reached for Schedule 1 (q2w) or when 2 or more patients experience a dose delay of at least 7 days at the same dose level for Schedule 1. The provisional dose levels are 20, 40, 60, 90, and 120 mg/m2, and intermediate and additional dose levels may be added as needed.
  • Experimental: Part 2 - Dose Expansion
    Patient to receive SMP-3124LP continuous IV infusion at the Recommended Phase 2 Dose as determinated in part 1.

Primary Outcome Measure

Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs) [ Time Frame: 28 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Clinical Program Manager
[email protected]
310-423-2133
Sarah Cannon Research Institute at HealthOneDenverColorado80218
Gerald Falchook, MD
[email protected]
720-754-2610
Northwestern Medicine Cancer CenterChicagoIllinois60611
Cancer Trial Office
[email protected]
312-695-9367
Ohio State UniversityColumbusOhio43210
Matthew Donnelly
[email protected]
614-292-4231
SCRI Oncology PartnersNashvilleTennessee37203
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232
Clinical Trials Office
[email protected]
800-811-8480
MD Anderson Cancer CenterHoustonTexas77030
Timothy Yap, MD
University of WashingtonSeattleWashington98105
Research Office
[email protected]
206-606-7438

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Medical Center· Los Angeles, CASarah Cannon Research Institute at HealthOne· Denver, CONorthwestern Medicine Cancer Center· Chicago, ILOhio State University· Columbus, OHSCRI Oncology Partners· Nashville, TNVanderbilt-Ingram Cancer Center· Nashville, TN

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