Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

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in Adult Subjects With Advanced Bladder Cancer JAVLOR® Online Non-Interventional Trial A Study to Investigate The Effectiveness Of Atezolizumab In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce) Neoadjuvant Dose Dense MVAC in MIBC and Locally Advanced Urothelial Carcinoma Alisertib in Chemotherapy-pretreated Urothelial Cancer Phase I Study With Sorafenib in Addition to Vinflunine in Metastatic Transitional Cell Carcinoma of the Urothelial Tract Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence Study of Sitravatinib and Nivolumab in Urothelial Carcinoma Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence Biological Effect of Vitamin D in Patients With Urothelial Carcinoma 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Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy The Cxbladder Monitoring Study Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina A Clinical Study of PD-L1 Antibody ZKAB001（Drug Code） in Locally Advanced and Metastatic Urothelial Carcinoma Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium Application of UCAD for Diagnosing Urothelial Carcinoma. A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma CLE Characteristics of Upper Urinary Tract Urothelial Carcinoma EGCG Modulate the Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells A Trial of Cabazitaxel for Advanced Transitional Cell Carcinoma (TCC) Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC Weekly TP-HDFL in the Treatment of Advanced TCC Detecting Transitional Cell Carcinoma From Haematuria Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU) Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma Trebananib (AMG 386) in Combination With Docetaxel for Advanced Urothelial Carcinoma Vasculogenic Mimicry in Urothelial Carcinoma Treatment of Locally Advanced or Metastatic Transitional Cell Carcinoma With Cabazitaxel Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma DNA Methylation and Urothelial Carcinoma JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin DNA Methylation and Arsenic-associated Urothelial Carcinoma Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma.

Brief Title

Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

Official Title

EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors

Brief Summary

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

Detailed Description

      This phase 2, multicenter, open-label study is designed to assess the safety and efficacy of
      lurbinectedin monotherapy in 3 cohorts of participants with high-unmet medical need: advanced
      (metastatic and/or unresectable) urothelial cancer (UC), poorly differentiated neuroendocrine
      carcinomas (PD-NEC), and a homologous recombination deficient-positive malignancies agnostic
      cohort.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

Secondary Outcome

 Investigator-Assessed Progression Free Survival (PFS) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

Condition

Advanced Solid Tumor

Intervention

Lurbinectedin

Study Arms / Comparison Groups

 Urothelial Cancer Cohort
Description:  Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

60

Start Date

March 3, 2022

Completion Date

June 23, 2024

Primary Completion Date

November 23, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Signed informed consent

          2. ≥ 18 years of age

          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          4. Adequate organ and bone marrow function

          5. Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

          6. Have advanced (metastatic/unresectable) cancers in one of the following:

               1. Histologically or cytologically confirmed urothelial cancer

               2. Histologically or cytologically confirmed poorly differentiated neuroendocrine
                  carcinoma

               3. Histologically or cytologically confirmed homologous recombination
                  deficient-positive malignancies agnostic, which may include endometrial, biliary
                  tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or
                  esophageal solid tumors with preidentified germline and/or somatic pathogenic
                  mutation

          7. Adequate contraceptive precautions

        Exclusion Criteria:

          1. Known symptomatic central nervous system (CNS) metastasis requiring steroids

          2. History of prior malignancy within 2 years of enrollment

          3. Clinically significant cardiovascular disease

          4. Active infection requiring systemic therapy

          5. Significant non-neoplastic liver disease

          6. Prior treatment with trabectedin or lurbinectedin

          7. Treatment with an investigational agent within 4 weeks of enrollment

          8. Received live vaccine with 4 weeks of first dose

          9. Prior allogeneic bone marrow or solid organ transplant

         10. Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening

         11. Positive human immunodeficiency virus (HIV) infection at screening

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 215-832-3750, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT05126433

Organization ID

JZP712-201

Responsible Party

Sponsor

Study Sponsor

Jazz Pharmaceuticals

Study Sponsor

, ,

Verification Date

March 2023