RecruitingPhase 1/2

SMP-3124LP in Adults With Advanced Solid Tumors

United States, Japan120 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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Solid Tumor trials