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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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or 1-800-679-0775 Learn More

Overview

Study Title

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

Summary

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

Objective

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.

Treatments

Therapies

Chemotherapy (NOS); Therapy (NOS)

Medications

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

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