SMP-3124LP in Adults With Advanced Solid Tumors

February 25, 2026 updated by: Sumitomo Pharma America, Inc.

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Phase 1/2, global, multicenter, open-label, first-in-human, clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of SMP-3124

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Kashiwa-shi, Japan, 277-8577
      • Kyoto, Japan, 606-8507
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80218
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Medicine Cancer Center
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Contact:
          • Clinical Trials Office
          • Phone Number: 800-811-8480
          • Email: ctip@vumc.org
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
          • Timothy Yap, MD
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- 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.

For patients in the Dose Escalation part:

  1. Platinum-resistant ovarian cancer

    • Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)
    • Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy

  2. Triple negative breast cancer - ER- and PR-negative with HER2 negative

    • HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines
    • ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors by IHC, as per standard guidelines

  3. Squamous cell carcinoma of the anus

    - Patient with locally advanced ineligible for surgery is allowed.

  4. Squamous cell carcinoma of the head and neck
  5. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)

  6. Uterine serous cancer (recurrent or persistent)

    For Patients in the Dose Expansion Part:

  7. Cohort A: PROC (same as above)
  8. Cohort B: TNBC (same as above)

  9. Cohort C: SCCA (same as above)

    • ECOG performance </= 2 at screening
    • Recovered from any prior treatment related toxicities
    • Adequate organ function as evidenced by:

a. Hemoglobin >/= 9 g/dL (transfusion or use of erythropoietin to obtain this are not permitted) b. Absolute neutrophil count >/= 1500 uL (platelet transfusion not allowed to achieve this) c. Platelet count >/= 100 x 10 (platelet transfusion not alled to achieve this) d. Bilirubin </= 1.5 x ULN (or </= 3.0 x if ULN if Gilbert's syndrome) e. AST and ALT </= 3.0 x ULN (or </= 5 x ULN if the liver has tumor involvement f. Calculated creatinine clearance >/= 60 mL/min using Cockcroft-Gault formula

  • Patient is non-fertile or agrees to use adequate methods of contraception or agrees to refrain completely from heterosexual intercourse during the study and for 6 months (for female and male patients alike) after the last dose of study intervention.

  • May be HIV positive if the following conditions are met:

    1. CD4 + T-cell count >/= 350 cells/uL
    2. HIV viral load < 400 copies/ml prior to enrollment
    3. No history of acquired immunodefficiency syndrome (AIDS) defining opportunistic infections
  • Known hepatitis B infection mush have negative serum HbsAg. Patients with known hepatitis C virus infection must have a viral load below the limit of quantification Japan sites only: HBc antibody or HBsantibody tests should be performed if HBsAg is negative. If HBc antibody or HBs antibody tests are positive, HBV DNA quantitative tests should be performed to confirm that HBV DNA is negative.

Exclusion Criteria:

  • Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
  • Patient has a known allergy or sensitivity to any component of SMP-3124LP, including the inactive ingredients
  • Patient has received treatment with systemic anticancer therapy, radiotherapy, or investigational therapy within 14 days prior to Study Cycle 1 Day 1. (Palliative radiotherapy with a limited field of radiation within 2 weeks will be permitted.)
  • Patient has undergone a major surgical procedure ≤ 28 days, or minor surgical procedure ≤ 7 days, prior to Cycle 1 Day 1
  • Patient has used strong CYP1A2 or 2D6 inhibitors within 14 days or 5 half-lives, whichever occurs first, prior to Cycle 1 Day 1 (examples of restricted CYP1A2 and CYP2D6, P-gp, and/or BCRP inducers, inhibitors, or substrates are presented in Table 16)
  • Patient has central nervous system metastasis or leptomeningeal disease
  • Prior or concurrent malignancy whose natural history or treatment would have a significant potential to interfere with the safety or efficacy assessments of the investigational regimen
  • Patient has an abnormal ECG that is clinically significant, including a corrected QT interval (corrected using Fridericia's correction formula [QTcF]) > 470 msec; and/or a history of Torsade de Pointes
  • Patient has a left ventricular ejection fraction < 45% by echocardiogram (ECHO)
  • Patient has clinically significant cardiac disease including heart failure (eg, New York Heart Association, Class III or IV)
  • Patient has an active, uncontrolled, bacterial, viral, or fungal infection requiring parenteral antimicrobial within 1 weeks prior to Cycle 1 Day 1
  • Patient is pregnant (as evidenced by a positive serum or urine pregnancy test) or is breastfeeding. Female breastfeeding patients may be enrolled if they interrupt breastfeeding. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug.

For sites in Japan only: In addition to the above, any patient deemed likely to be pregnant based on medical interview will be excluded from the study.

  • Patient with ovarian cancer

    1. Has a history of bowel obstruction related to their underlying disease within 3 months prior to Study Day 1
    2. Has platinum-refractory disease. Platinum refractory is defined as progression during platinum-based chemotherapy
  • Patient has any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with their participation in the trial or interfere with the interpretation of trial results
  • Patient is taking a prohibited medication at baseline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 - Dose Escalation & Dose Optimization

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.
Drug: SMP3124LP
Liposomal encapsulation formulation of SMP-3124
Experimental: Part 2 - Dose Expansion
Patient to receive SMP-3124LP continuous IV infusion at the Recommended Phase 2 Dose as determinated in part 1.
Drug: SMP3124LP
Liposomal encapsulation formulation of SMP-3124

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)
Time Frame: 28 days
28 days
Number of Participants With Adverse Events and Serious Adverse Events
Time Frame: 6 months
6 months
Determine the Objective Response Rate (ORR)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The maximum concentration (Cmax) of SMP-3124 and SMP-3124LP
Time Frame: 6 months
6 months
The area under the curve (AUC) of SMP-3124 and SMP-3124LP
Time Frame: 6 months
6 months
The duration of response (DOR) assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma America, Inc.

Investigators

  • Study Director: Jian Li, MD, jian.li@us.sumitomo-pharma.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMP-3124-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solid Tumor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe