Solid Tumor study: SMP3124LP
Official title SMP-3124LP in Adults With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06526819
What this study is testing
What is SMP3124LP?
an investigational liposomal drug being studied as a potential treatment for advanced solid tumors
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
- The study is looking at the safety, how well people tolerate it, and any early signs that the drug might shrink tumors.
- Who it's for
- Adults who have advanced solid tumors.
- What's involved
- Participants will receive SMP 3124LP, starting at low doses that increase (Phase I) and then at a selected dose (Phase II). They will have regular clinic visits for safety checks, lab tests, and imaging scans.
- Time commitment
- The trial runs for several months and requires multiple clinic visits for dosing and assessments.
- 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
- 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
- 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...
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
- 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)
- 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.
- 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...
- 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...
- 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.
- 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.
- 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 is enrolling
- Los Angeles, California, United States
- Denver, Colorado, United States
- Celebration, Florida, 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, but 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?
This study is enrolling now at Los Angeles, California, United States; Denver, Colorado, United States; Celebration, Florida, United States; Chicago, Illinois, United States; Columbus, Ohio, United States; Nashville, Tennessee, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.