AzTrials
AzTrials

Gastrointestinal MalignanciesPhase 2NCT05229588

Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations

A Phase 2 study testing Lurbinectedin 4 MG Injection [Zepzelca] in people with Gastrointestinal Malignancies, run by HonorHealth Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this research is to evaluate the activity and safety of lurbinectedin in adult patients with advanced Gastrointestinal Malignancies with DNA repair mutations. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Malignancies
What is being tested?
Lurbinectedin 4 MG Injection [Zepzelca]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
14 Jun 2022to 4 Aug 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary written informed consent form (ICF) of the patient obtained before any study-specific procedure.
  • Age ≥ 18 years of age; male or female.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≤1
  • Histologically or cytologically confirmed gastrointestinal carcinoma
  • Locally advanced unresectable or metastatic disease at study entry
  • Known deleterious or suspected deleterious (or equivalent interpretation) mutations in DNA repair in ATM, ATR, CHEK2, BRCA1, BRCA2, RAD51, BRIP1, PALB2, PTEN, FANC, NBN, EMSY, MRE11, or ARID1A prior to study entry
Show all 22Show fewer
  • Progressive disease to prior treatment. Patients no longer able to continue prior treatment due to intolerable toxicity may be considered for study participation provided that radiology assessment confirms either stable disease or disease progression (i.e., no response to treatment).
  • Measurable tumor lesions according to RECIST 1.1 criteria.
  • Adequate hematological, renal, metabolic and hepatic function, defined as:
  • Hemoglobin ≥9 g/dL (patients may have received prior red blood cell [RBC] transfusion, if clinically indicated); absolute neutrophil count (ANC) ≥1.5 x 109/L, and platelet count ≥100 x 109/L.
  • Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3.0 x upper limit of normal (ULN).
  • Total bilirubin ≤ ULN.
  • Albumin ≥3.0 g/dL.
  • Calculated creatinine clearance (CrCL) ≥30 mL/min (according to the Cockcroft and Gault´s formula).
  • 11. Washout periods prior to Day 1 of Cycle 1:
  • At least three weeks since last prior chemotherapy and/or investigational drugs.
  • At least four weeks since the last radiotherapy (RT) > 30 Gy.
  • At least two weeks since the last palliative RT (≤ 10 fractions or ≤ 30 Gy total dose).
  • Patients with prior malignancy successfully treated who are currently stable and on no active treatment are eligible.
  • Recovery to grade ≤1 from any adverse event (AE) derived from previous anticancer treatment (excluding alopecia and/or skin toxicity of any grade and grade ≤2 peripheral neuropathy) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v.5).
  • Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure* during the trial and up to six weeks after treatment discontinuation, and fertile male patients with WOCBP partners must agree to refrain from fathering a child or donating sperm during the trial and up to four months after treatment discontinuation.
  • Highly effective methods: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence

Who cannot join

  • Prior treatment with lurbinectedin or trabectedin
  • Neuroendocrine differentiation subtype in histology
  • More than three prior systemic chemotherapy lines for advanced disease
  • Known brain metastases or leptomeningeal disease involvement
  • Concomitant diseases/conditions:
  • History of cardiac disease: myocardial infarction or symptomatic/uncontrolled angina within the year prior to enrollment; or pain history of left ventricular ejection fraction (LVEF) ≤ 50% assessed by multiple-gated acquisition scan (MUGA) or equivalent by ultrasound (US); or symptomatic arrhythmia.
Show all 15Show fewer
  • Generalized edema, and/or ascites clinically evident or requiring drainages within three weeks prior to study entry. Permanent external drainages due to ascites are also excluded.
  • Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV).
  • Known chronically active hepatitis B virus (HBV) or hepatitis C virus (HCV). For hepatitis B, this includes positive tests for both hepatitis B surface antigen and quantitative hepatitis B polymerase chain reaction (PCR). For hepatitis C, this includes positive tests for both hepatitis C antibody and quantitative hepatitis C PCR.
  • Active uncontrolled infection.
  • Limitation of the patient's ability to comply with the treatment or to follow-up the protocol.
  • Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
  • Patients acutely ill and/or in immediate vital distress, including those with rapidly deteriorating clinical condition or who may require unscheduled hospitalizations due to uncontrolled disease symptoms within the prior two weeks to treatment registration.
  • Pregnant or breastfeeding women.
  • Live vaccine administration within 3 weeks of study entry

Trial locations and contacts

1 site in 1 country.

United States1 site

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase II Pilot Clinical Trial of Lurbinectedin (Zepzelca™ PM01183) in Patients With Gastrointestinal Malignancies With DNA Repair Mutations

The purpose of this research is to evaluate the activity and safety of lurbinectedin in adult patients with advanced Gastrointestinal Malignancies with DNA repair mutations.

Being tested
Lurbinectedin 4 MG Injection [Zepzelca]
Keywords
Gastrointestinal Malignancies, phase II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lurbinectedin 4 MG Injection [Zepzelca]Drug

    Also called PM01183

    Lurbinectedin will be administered with a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride).

    Lurbinectedin will be administered intravenously through peripheral or central lines at a dose of 3.2 mg/m2 at a fixed infusion rate.

Study groups in NCT05229588
Study groupRoleWhat they receive
LurbinectedinExperimentalLurbinectedin will be administered intravenously (IV) as a 1-hour (±10 min) infusion on Day 1 of each cycle (one cycle = 3 weeks ± 48 hours).
Receives: Drug: Lurbinectedin 4 MG Injection [Zepzelca]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR) at 12 Weeks

    The antitumor activity of lurbinectedin was measured in terms of overall response rate (ORR) at 12 weeks.

    ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) according to RECIST v.1.1. CR was defined as the complete radiologic disappearance of all target lesions, while PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions.

    Measured: 12 weeks

Secondary outcomes (9)

  1. Duration of Response (DOR)

    Duration of response (DOR) was defined as the time from when a participant was reported to respond to lurbinectedin treatment (complete response (CR) or partial response (PR) by RECIST v1.1) to the time when they experienced progressive disease (PD) or death.

    CR was defined as the complete radiologic disappearance of all target lesions, PR as at least a 30% decrease in the sum of the longest diameter of target lesions, and PD as at least a 20% increase in the sum of the longest diameter of target lesions.

    Measured: From initiation of study treatment up to study completion, up to 20 months

  2. Clinical Benefit

    Clinical benefit was defined as the percentage of patients with a complete response (CR), partial response (PR), or stable disease (SD), as measured by RECIST v.1.1, for ≥4 months.

    CR was defined as the complete radiologic disappearance of all target lesions, PR as at least a 30% decrease in the sum of the longest diameter of target lesions, and SD as no change in the sum of the longest diameter of target lesions.

    Measured: From 4 months up to 20 months

  3. Normalization of Tumor Markers

    The number of participants with > 2 x ULN tumor marker values at baseline who had their tumor marker values normalize to at or below ULN after receiving lurbinectedin therapy.

    Tumor markers included CA19-9 and CEA for non-expressors of CA 19-9. ULN was defined at 35 U/mL for CA 19-9 and 3 ng/mL for CEA.

    Measured: From initiation of study treatment until end of study treatment, up to 9.1 weeks

  4. Progression-free Survival (PFS)

    Progression-free survival (PFS) was defined as the time from the first infusion of lurbinectedin to the date of progressive disease, death (of any cause), or last tumor evaluation.

    Measured: From initiation of study treatment to disease progression/death/last tumor evaluation, up to 4.1 months

  5. Progression-free Survival Rate at Three Months (PFS3)

    Progression-free survival rate at three months (PFS3) was defined as the percentage of patients who were alive and progression-free three months after the first infusion of lurbinectedin.

    Measured: 3 months

  6. Overall Survival (OS)

    Overall survival (OS) was defined as the time from the first infusion of lurbinectedin to the date of death (of any cause) or last patient contact.

    Measured: From initiation of study treatment to date of death/last patient contact, up to 20 months

  7. Overall Survival Rate at Six Months (OS6)

    Overall survival rate at six months (OS6) was defined as the percentage of patients who were alive six months after the first infusion of lurbinectedin.

    Measured: 6 months

  8. Overall Survival Rate at 12 Months (OS12)

    Overall survival rate at 12 months (OS12) was defined as the percentage of patients who were alive 12 months after the first infusion of lurbinectedin.

    Measured: 12 months

  9. Adverse Events Possibly or Definitely Related to Lurbinectedin

    Adverse events (AEs) were graded and collected according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). AEs that were determined to be possibly or definitely related to lurbinectedin are reported here.

    The AE grading scale for NCI-CTCAE v5.0 is as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe, non-life threatening; Grade 4 - life-threatening; Grade 5 - death.

    Measured: From initiation of study treatment to end of follow-up, up to 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start14 Jun 2022
  3. Primary completion4 Aug 2025
  4. Study completion4 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05229588
Sponsor's protocol ID
HRI-Lurbinectedin-001
Status last verified
Aug 2025
First submitted
5 Jan 2022
Last updated
11 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lurbinectedin 4 MG Injection [Zepzelca] in people with Gastrointestinal Malignancies, run by HonorHealth Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) at 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05229588.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in