RecruitingPhase 1/2

SMP-3124LP in Adults With Advanced Solid Tumors

United States120 participantsStarted 2024-08-14

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Platinum-resistant ovarian cancer
✓. Triple negative breast cancer - ER- and PR-negative with HER2 negative
✓. Squamous cell carcinoma of the anus
✓. Squamous cell carcinoma of the head and neck
✓. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)
✓. Uterine serous cancer (recurrent or persistent)
✓. Cohort A: PROC (same as above)
✓. Cohort B: TNBC (same as above)

Exclusion criteria

✕. Has a history of bowel obstruction related to their underlying disease within 3 months prior to Study Day 1
✕. Has platinum-refractory disease. Platinum refractory is defined as progression during platinum-based chemotherapy

What they're measuring

Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)

Timeframe: 28 days

Number of Participants With Adverse Events and Serious Adverse Events

Timeframe: 6 months

Determine the Objective Response Rate (ORR)

Timeframe: 6 months

Trial details

NCT IDNCT06526819

SponsorSumitomo Pharma America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Eileen Maunsell

774-405-5069 eileen.maunsell@us.sumitomo-pharma.com

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