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Monoclonal Antibodies

Part 2 - Dose Expansion for Solid Tumors

Phase 1 & 2
Waitlist Available
Research Sponsored by Sumitomo Pharma America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Histologically or cytologically-confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit.
1. Platinum-resistant ovarian cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

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 is the study for?
This trial is for adults with advanced solid tumors who have not responded to standard treatments. Specific eligibility details are not provided, but typically participants must be in good overall health aside from their cancer and able to comply with study requirements.
What is being tested?
The trial is testing SMP3124LP's safety, tolerability, and initial effectiveness against solid tumors. It has two parts: the first part tests increasing doses to find the safest dose (Phase 1), and the second part expands on this dose in more patients (Phase 2).
What are the potential side effects?
While specific side effects of SMP3124LP are not listed here, common side effects for cancer drugs can include nausea, fatigue, hair loss, skin reactions, and increased risk of infection. The exact profile will be determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)
Determine the Objective Response Rate (ORR)
Number of Participants With Adverse Events and Serious Adverse Events
Secondary study objectives
The area under the curve (AUC) of SMP-3124 and SMP-3124LP
The duration of response (DOR) assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
The maximum concentration (Cmax) of SMP-3124 and SMP-3124LP

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 - Dose ExpansionExperimental Treatment1 Intervention
Patient to receive SMP-3124LP continuous IV infusion at the Recommended Phase 2 Dose as determinated in part 1.
Group II: Part 1 - Dose Escalation & Dose OptimizationExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
240 Previous Clinical Trials
52,997 Total Patients Enrolled
Jian Li, MDStudy Directorjian.li@us.sumitomo-pharma.com
5 Previous Clinical Trials
290 Total Patients Enrolled
~80 spots leftby Dec 2028
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