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New treatment option for Solid Tumor
Official title SMP-3124LP in Adults With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06526819
What this study is testing
What is SMP3124LP?
SMP3124LP is an investigational medicine, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Histologically or cytologically-confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease...
- Platinum-resistant ovarian cancer
- Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features...
- 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
You likely can't join if
- 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...
- 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...
- Patient has central nervous system metastasis or leptomeningeal disease
See the full eligibility criteria
Who can 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...
- 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
- 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: 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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 how well it works 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Denver, Colorado, United States
- Chicago, Illinois, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Kashiwa-shi, Japan
- Kyoto, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Denver, Colorado, United States; Chicago, Illinois, United States; Columbus, Ohio, United States; Nashville, Tennessee, United States; Houston, Texas, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.