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Monoclonal Antibodies

SMP-3124LP for Cancer

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 specific origins and disease progression on standard therapy with no alternative therapies for overall survival benefit
Requirements for patients with known hepatitis B or C infection
Must not have
Taking prohibited medication at baseline
Prior treatment with a cell cycle checkpoint inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new drug called SMP 3124LP in adults with advanced solid tumors to see if it is safe and effective in treating their cancer.

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
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My cancer is advanced, has come back, or spread, and hasn't responded to standard treatments.
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I have hepatitis B or C.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medication that is not allowed in the study.
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I have been treated with drugs that target cell cycle checkpoints before.
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My cancer has spread to my brain or spinal cord.
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I have heart issues or an abnormal heart test result.
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I do not have any ongoing serious infections.
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I am not taking medication that strongly affects liver enzymes CYP1A2 or 2D6.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
242 Previous Clinical Trials
53,016 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