Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (JAZZ EMERGE201)

Jazz Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Poorly Differentiated Neuroendocrine Carcinomas; Urothelial Cancer; Advanced Solid Tumor; Homologous Recombination Deficient-Positive Malignancies Agnostic; Metastatic Solid Tumor

Treatments: Drug: Lurbinectedin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05126433

JZP712-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

Urothelial Cancer Cohort

Experimental group

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.

Treatment:

Drug: Lurbinectedin

Poorly Differentiated Neuroendocrine Carcinomas Cohort

Experimental group

Description:

Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy 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.

Treatment:

Drug: Lurbinectedin

Homologous Recombination Deficient-Positive Malignancies Agnostic Cohort

Experimental group

Description:

Participants with advanced (metastatic and/or unresectable) 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 and received at least 1 prior line of therapy 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.

Treatment:

Drug: Lurbinectedin