SMP-3124LP in Adults With Advanced Solid Tumors
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests SMP-3124LP in adults with certain advanced solid tumors that grew despite standard treatment. It looks at safe doses, side effects, and early signs that the drug works against cancer.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have cancer confirmed by a tissue or cell test that is advanced, has come back, or has spread. Standard treatment must have failed, with no other treatment expected to help you live longer.
- For the dose-finding part: have certain ovarian, fallopian tube, or abdominal lining cancers; triple-negative breast cancer; squamous cell cancer of the anus, head, or neck; non-small cell lung cancer; or uterine serous cancer that remains or has returned.
- For the dose-expansion part: have eligible ovarian-related cancer, triple-negative breast cancer, or squamous cell cancer of the anus. Ovarian-related cancers must have mainly high-grade serous or clear cell features and have returned within 6 months after the last platinum-based treatment.
- Be able to care for yourself and be up and about at least half of your waking hours. Have recovered from side effects of past treatment.
- Have blood counts and liver and kidney test results that meet study limits. Some blood counts must meet these limits without transfusions or medicines to raise them.
- Be unable to have children, use suitable birth control, or avoid sex that could cause pregnancy during the study and for 6 months after the last dose.
- If you have HIV, have a CD4 immune cell count of at least 350, a virus level below 400 copies/mL, and no past AIDS-defining infections.
- If you have known hepatitis B or C, meet the required virus test limits. Extra hepatitis B testing may be needed at sites in Japan.
Who can't join
- Have ever taken a cell cycle checkpoint inhibitor, a drug that blocks proteins such as CHK1, CHK2, WEE1, or ATR. Have an allergy to any ingredient in SMP-3124LP.
- Had cancer drug treatment, radiation, or experimental treatment within 14 days before starting. Limited-area radiation for symptom relief may be allowed. Had major surgery within 28 days or minor surgery within 7 days.
- Take a medicine the study does not allow, or recently took certain medicines that strongly block the CYP1A2 or CYP2D6 drug-processing proteins.
- Have cancer that has spread to the brain, spinal cord, or their lining, or another cancer that could affect the study's safety or results.
- Have certain serious heart problems, including important abnormal heart tracing results, a history of a dangerous heart rhythm called Torsade de Pointes, or heart pumping strength below 45%.
- Have an active, uncontrolled infection needing injected treatment within the week before starting, or another medical or mental health condition that could affect participation or study results.
- Are pregnant or breastfeeding. Breastfeeding may be stopped to join, but cannot restart until at least 6 months after the last dose. In Japan, suspected pregnancy also rules out joining.
- For ovarian cancer: had a cancer-related bowel blockage within 3 months before starting, or cancer grew during platinum-based chemotherapy.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (11)
CA
- Cedars Sinai Medical Center · Los Angeles, CA 90048Clinical Program Manager · Study contact · 310-423-2133 · cancer.trial.info@cshs.orgOmid Hamid, MD · Principal investigatorMore trials in Los Angeles
- University of California, San Francisco · San Francisco, CA 94143Clinical Research Manager · Study contact · gynoncclinicaltrials@ucsf.eduEdwin Alvarez, MD · Principal investigatorMore trials in San Francisco
CO
- Sarah Cannon Research Institute at HealthOne · Denver, CO 80218Gerald Falchook, MD · Study contact · 720-754-2610 · cann.ddudenvergeneral@sarahcannon.comMore trials in Denver
FL
- Advent Health · Celebration, FL 32804Advent Health Oncology Research · Study contact · GroupCancerTrialInformation@cshs.orgMore trials in Celebration
IL
- Northwestern Medicine Cancer Center · Chicago, IL 60611Cancer Trial Office · Study contact · 312-695-9367 · cancer@northwestern.eduMore trials in Chicago
- The University of Chicago · Chicago, IL 60637Katherine Kurnit, MD · Study contact · cancerclinicaltrials@bsd.uchicago.eduMore trials in Chicago
OH
- Ohio State University · Columbus, OH 43210Matthew Donnelly · Study contact · 614-292-4231 · Matthew.Donnelly@osumc.eduMore trials in Columbus
TN
- SCRI Oncology Partners · Nashville, TN 37203 · Study contact · scri.ddureferrals@scri.comMore trials in Nashville
- Vanderbilt-Ingram Cancer Center · Nashville, TN 37232Clinical Trials Office · Study contact · 800-811-8480 · ctip@vumc.orgMore trials in Nashville
TX
- MD Anderson Cancer Center · Houston, TX 77030Timothy Yap, MD · Study contactMore trials in Houston
WA
- University of Washington · Seattle, WA 98105Research Office · Study contact · 206-606-7438 · GynResearch@fredhutch.orgMore trials in Seattle