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Recruiting NCT06526819

SMP-3124LP in Adults With Advanced Solid Tumors

Conditions: Solid Tumor

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 120
Sponsor: Sumitomo Pharma America, Inc.

Location: Cedars Sinai Medical Center Los Angeles California

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

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 \/= 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 \ 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06526819). StuddyBuddy aggregates publicly available trial information.