Solid Tumor / SMP3124LP · Phase 1/2 Trial

SMP-3124LP in Adults With Advanced Solid Tumors

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 1/2 dose escalation and expansion study of SMP-3124LP in adults with advanced solid tumors. No efficacy or safety results are yet reported in this registry record. The study aims to establish the recommended Phase 2 dose, characterise safety and tolerability, and assess preliminary antitumor activity over 6 months of follow-up.

What was studied

Phase 1/2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Solid Tumor; age from 18 Years. Intervention: Part 1 - Dose Escalation & Dose Optimization; Part 2 - Dose Expansion. n = 120. 12 sites: United States, Japan.

Key findings

Safety

No safety, tolerability, or efficacy data are yet reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a recruiting Phase 1/2 clinical trial registry record with no results posted; it describes planned study design and endpoints only.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs) (assessed at 28 days); Number of Participants With Adverse Events and Serious Adverse Events (assessed at 6 months); Determine the Objective Response Rate (ORR) (assessed at 6 months)

DesignPhase 1/2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose

PopulationSolid Tumor; age from 18 Years

Sample size120

InterventionPart 1 - Dose Escalation & Dose Optimization; Part 2 - Dose Expansion

Setting12 sites: United States, Japan

Reported figures

Quoted from the source exactly as published.

Planned enrollment120

PhasePhase 1/2

Primary endpoint 1Determination of Recommended Phase 2 Dose by DLT assessment at 28 days

Primary endpoint 2Number of participants with adverse events and serious adverse events at 6 months

Primary endpoint 3Objective Response Rate at 6 months

Caveats

This is a registry record only; no results are posted or available.
Study is currently recruiting; enrollment target of 120 is estimated, not final.
Open-label design without control arm or blinding.
No safety, tolerability, or efficacy data are yet reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Open-label Phase 1 dose escalation and Phase 2 expansion; no blinding.

Directness

moderate

Primary endpoints include DLTs, safety, and ORR in advanced solid tumors.

Consistency

insufficient

Registry record only; no results reported for consistency assessment.

Risk of bias

limited

Open-label design introduces risk of bias; no results posted to assess.

Sample adequacy

limited

Estimated 120 participants planned; recruitment ongoing, actual enrollment unknown.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06526819). This is a study registration, not published results. Lead sponsor: Sumitomo Pharma America, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Solid Tumor. Interventions: DRUG: SMP3124LP. Primary outcome measures: Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs) , 28 days; Number of Participants With Adverse Events and Serious Adverse Events , 6 months; Determine the Objective Response Rate (ORR) , 6 months. Brief 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Solid TumorNCT06526819SMP3124LPSumitomo Pharma America