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Clinical Trial 21698

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT05126433

Phase: Phase II
Principal Investigator: Shafique, Michael

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Study Title

A Phase 2, Multicenter, Open-Label Study of Lurbinectedin Efficacy and Safety in Participants with Advanced or Metastatic Solid Tumors


This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.


Primary * To evaluate the antitumor activity of lurbinectedin in the selected advanced solid tumors Secondary * To evaluate the overall safety profile of lurbinectedin in the selected advanced solid tumors * To assess other antitumor efficacy parameters of lurbinectedin in the selected advanced solid tumors. * To assess OS in participants treated with lurbinectedin in the selected advanced solid tumors.



Chemotherapy (NOS); Therapy (NOS)


Dexamethasone (); Metoclopramide (); Ondansetron (); PM01183 (lurbinectedin); Zofran (Ondansetron); lurbinectedin ()

Inclusion Criteria

  • Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • 18 years of age at time of signing consent
  • ECOG performance status of 0 or 1.
  • Life expectancy greater than or equal to 3 months
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate liver function
  • Measurable disease in accordance with RECIST v1.1
  • Male participants must agree to the following during the study and at least 4 months after last dose of study intervention: refrain from donating sperm, be abstinent from heterosexual intercourse or agree to use contraception/barrier as detailed in protocol.
  • Female participants are eligible if not pregnant or breastfeeding and one of the following conditions apply: is a woman of non-childbearing potential,or is a woman of childbearing potential (WOCBP) using a contraceptive method that is highly effective as outlined in protocol.
  • WOCBP must have a negative highly sensitive pregnancy test within 7 days before first dose of study intervention
  • Patients with advanced (metastatic and/or unresectable) cancer who meet the following criteria for individual cohorts:
  • Urothelial Cancer Cohort:
  • Has histologically or cytologically documented advanced (metastatic and/or unresectable) urothelial (transitional cell) carcinoma of the bladder, urethra, ureter, or renal pelvis (mixed histology tumors is allowed if predominant histology is urothelial carcinoma. Small cell or NEC is NOT allowed if predominant).
  • Has progressed on a platinum-containing regimen (cisplatin ineligible participants who have received only an immune CPI as their first-line treatment are allowed). Prior therapies may include but are not limited to immune CPI, enfortumab vendotin, or sacituzumab govitecan. Platinum followed by avelumab maintenance is considered as one line of therapy. − Prior cytotoxic therapy in an adjuvant or neoadjuvant setting is not considered as a prior line of systemic chemotherapy in the relapsed or metastatic setting if administered > 12 months prior to enrollment.
  • Poorly Differentiated Neuroendocrine Carcinomas Cohort:
  • Has histology or cytology confirmed advanced (metastatic and/or unresectable) PD-NEC of any origin. SCLC patients are not eligible in this cohort. Histologically defined LCNET of lung are eligible regardless of previous diagnosis and treatment.
  • Received at least 1 prior line of therapy.
  • Homologous Recombination Deficient-positive Malignancies Agnostic Cohort:
  • Note: Participants must have previous mutational and genomic analysis results that will confirm the following eligibility criteria for potential participation.
  • Has histologically or cytologically confirmed advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2 breast cancer), pancreas, gastric, or esophageal solid tumor, irrespective of PD-L1 status.
  • Has a pre-identified germline and/or somatic pathogenic mutation (a mutation that significantly affects the function of genes associated with oncogensis in the following genes: BRCA1/2, PALB2, RAD51/51B/51C/51D, ATR, ATM, ARIDIA, BAP1, CHEK2, RAD50, RAD54) prior to enrollment.
  • Received at least 1 prior line of therapy
  • Patients who have received prior PARPi are allowed unless they progressed within
  • Exclusion Criteria

  • Known symptomatic central nervous system (CNS) metastasis requiring steroids
  • History of prior malignancy within 2 years of enrollment
  • Clinically significant cardiovascular disease
  • Active infection requiring systemic therapy
  • Significant non-neoplastic liver disease
  • Prior treatment with trabectedin or lurbinectedin
  • Treatment with an investigational agent within 4 weeks of enrollment
  • Received live vaccine with 4 weeks of first dose
  • Prior allogeneic bone marrow or solid organ transplant
  • Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
  • Positive human immunodeficiency virus (HIV) infection at screening

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.