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Solid TumorPhase 1/2NCT06526819

SMP-3124LP in Adults With Advanced Solid Tumors

A Phase 1/2 study testing SMP3124LP in people with Solid Tumor, run by Sumitomo Pharma America, Inc. at 13 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
SMP3124LP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
13 sitesin 2 countries
Study dates
14 Aug 2024to May 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • Triple negative breast cancer - ER- and PR-negative with HER2 negative
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  • 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
  • Squamous cell carcinoma of the anus
  • Patient with locally advanced ineligible for surgery is allowed.
  • 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)
  • For Patients in the Dose Expansion Part:
  • Cohort A: PROC (same as above)
  • Cohort B: TNBC (same as above)
  • Cohort C: SCCA (same as above)
  • ECOG performance </= 2 at screening
  • Recovered from any prior treatment related toxicities
  • Adequate organ function as evidenced by:
  • 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:
  • CD4 + T-cell count >/= 350 cells/uL
  • HIV viral load < 400 copies/ml prior to enrollment
  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • 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
  • 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.

Trial locations and contacts

13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Eileen Maunsell contact

774-405-5069

eileen.maunsell@us.sumitomo-pharma.com

Shuichi Iino contact

508-481-6700

shuichi.iino@us.sumitomo-pharma.com

13 sites in 2 countries

United States11 sites, 11 recruiting

  • Advent Health

    Celebration, Florida, 32804

    Advent Health Oncology Research, GroupCancerTrialInformation@cshs.org

    Recruiting

  • Northwestern Medicine Cancer Center

    Chicago, Illinois, 60611

    Cancer Trial Office, 312-695-9367, cancer@northwestern.edu

    Recruiting

  • The University of Chicago

    Chicago, Illinois, 60637

    Katherine Kurnit, MD, cancerclinicaltrials@bsd.uchicago.edu

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Matthew Donnelly, 614-292-4231, Matthew.Donnelly@osumc.edu

    Recruiting

  • Sarah Cannon Research Institute at HealthOne

    Denver, Colorado, 80218

    Gerald Falchook, MD, 720-754-2610, cann.ddudenvergeneral@sarahcannon.com

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Timothy Yap, MD

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Clinical Program Manager, 310-423-2133, cancer.trial.info@cshs.org

    Omid Hamid, MD

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    scri.ddureferrals@scri.com

    Recruiting

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

    Clinical Trials Office, 800-811-8480, ctip@vumc.org

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Clinical Research Manager, gynoncclinicaltrials@ucsf.edu

    Edwin Alvarez, MD

    Not yet recruiting

  • University of Washington

    Seattle, Washington, 98105

    Research Office, 206-606-7438, GynResearch@fredhutch.org

    Recruiting

Other trials in United States

Japan2 sites, 2 recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, 277-8577

    Kenichi Harano, MD, kharano@east.ncc.go.jp

    Recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507

    Ryusuke Murakami, MD, ryusukem@kuhp.kyoto-u.ac.jp

    Recruiting

Other trials in Japan

About this study

Official title: 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

Read the 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

Conditions
Solid Tumor
Being tested
SMP3124LP
Keywords
first in human, open label, platinum-resistant ovarian cancer (PROC), Triple Negative Breast Cancer (TNBC), Metastatic squamous cell carcinoma of the anus (MSCCA), Squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), uterine serous cancer
Medical subject headings
Triple Negative Breast Neoplasms, Anus Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMP3124LPDrug

    Liposomal encapsulation formulation of SMP-3124

Study groups in NCT06526819
Study groupRoleWhat they receive
Part 1 - Dose Escalation & Dose OptimizationExperimentalPatient 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.
Receives: Drug: SMP3124LP
Part 2 - Dose ExpansionExperimentalPatient to receive SMP-3124LP continuous IV infusion at the Recommended Phase 2 Dose as determinated in part 1.
Receives: Drug: SMP3124LP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)

    Measured: 28 days

  2. Number of Participants With Adverse Events and Serious Adverse Events

    Measured: 6 months

  3. Determine the Objective Response Rate (ORR)

    Measured: 6 months

Secondary outcomes (3)

  1. The maximum concentration (Cmax) of SMP-3124 and SMP-3124LP

    Measured: 6 months

  2. The area under the curve (AUC) of SMP-3124 and SMP-3124LP

    Measured: 6 months

  3. The duration of response (DOR) assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2024
  2. Study start14 Aug 2024
  3. Primary completionDec 2028 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06526819
Sponsor's protocol ID
SMP-3124-101
Status last verified
Oct 2026
First submitted
24 Jul 2024
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SMP3124LP in people with Solid Tumor, run by Sumitomo Pharma America, Inc. at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eileen Maunsell (774-405-5069, eileen.maunsell@us.sumitomo-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06526819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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SMP-3124LP in Adults With Advanced Solid Tumors | AzTrials