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Cancer of OvaryPhase 2NCT06478862

Promitil Treatment of Patients With Solid Tumors Associated With Deleterious Mutations Who Have Progressed After Therapy

A Phase 2 study testing Promitil in people with Cancer of Ovary and Pancreatic Ductal Adenocarcinoma, run by Lipomedix Pharmaceuticals Inc. at 6 sites in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This multicenter Phase 2a study was designed to evaluate the safety, tolerability, and efficacy of Promitil in patients with recurrent ovarian cancer and inoperable, locally advanced or metastatic pancreatic cancer, which bears deleterious germline or somatic mutations in BRCA1, BRCA2, or HRD (homologous recombination… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Promitil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
6 sitesIsrael
Study dates
13 Jun 2024to 2 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 18 years of age or older on day of consent
  • Patient with either one of the following histologically or cytologically confirmed, deemed incurable malignancies:
  • Recurrent ovarian cancer
  • Inoperable, locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
  • Patient with PDAC measurable by RECIST 1.1. Previously irradiated lesions may be considered measurable if there has been demonstrated progression in these lesions. Ovarian cancer patients can have either measurable or non-measurable lesions (i.e., ovarian cancer patients with mostly ascites or pleural effusion are eligible)
  • Tumor with a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2 or HRD-related genes as determined by a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited laboratory. Note: Patients with positive HRD score can be eligible regardless of any evidence for germline or somatic mutations
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  • Patient received at least 1 line of chemotherapy for advanced pancreatic adenocarcinoma or ovarian cancer. Prior neoadjuvant and adjuvant chemotherapy are allowed, and platinum re-challenge is allowed for ovarian cancer patients for whom it is felt to be in their best interests, as determined by the Investigator. Prior PARP inhibitor, hormonal, biological, or immunological therapy are allowed. Palliative radiation therapy is allowed, provided it was/will be completed ≥2 weeks prior starting trial therapy
  • Capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
  • ECOG performance status of 0 or 1
  • Adequate organ function as defined by:
  • Absolute neutrophil count (ANC) ≥ 1500/µL
  • Platelet count ≥ 100,000/µL
  • Hemoglobin ≥ 9.5 g/dL
  • Hematocrit ≥30%
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST and ALT ≤ 3 x ULN OR ≤ 5 x ULN in the presence of liver metastases
  • Albumin ≥ 3g/dL
  • INR<1.5 unless on anticoagulants
  • Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 45 mL/minute (as calculated by the Cockcroft-Gault formula)
  • Estimated life expectancy of at least 3 months
  • Patients (men and women) of reproductive potential willing and able to use an acceptable method of birth control as approved by the PI
  • With the exception of alopecia and neuropathy, resolution of all acute toxic effects of any prior chemotherapy, surgery or radiotherapy to NCI CTCAE (Version 5.0) Grade ≤ 1 or to the baseline laboratory values as defined in Inclusion Criteria Number 8 and 9.

Who cannot join

  • Uncontrolled intercurrent illness including, but not limited to, severe or ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements
  • Any other severe concurrent disease which, in the judgment of the investigator, would make the subject unsuited for treatment
  • History of chronic active hepatitis, including carriage of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless patient is adequately treated and shown to be serum virus-free
  • Evidence of active bleeding
  • Untreated brain metastases Note: Patients with brain metastases treated by surgery or radiation who are stable and symptom-free (≤ 4 mg dexamethasone/day) are eligible to participate in the study
  • Patient is pregnant or lactating
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  • Prior intravenous treatment with MMC, either alone or in combination
  • Other anti-cancer treatment within 2 weeks before start of study drug
  • Other myelosuppressive treatment within 4 weeks before start of study drug
  • Treatment with other investigational drugs within 5 drug half-lives of day 1 of study drug
  • Patients with uncontrolled ascites that had more than one palliative abdominal tap up to 30 days prior to Screening

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Israel6 sites

  • Soroka Medical Center

    Beersheba

  • Rambam Health Care Campus

    Haifa

  • Wolfson Medica Center

    Holon, 5822012

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Shamir Medical Center (Asaf Harofeh)

    Tsrifin, 70300

Other trials in Israel

About this study

Official title: A Phase 2A Multicenter, Open Label Study of Promitil for the Treatment of Patients With Solid Tumors Associated With Deleterious Mutations Who Have Progressed After First Line Therapy

This multicenter Phase 2a study was designed to evaluate the safety, tolerability, and efficacy of Promitil in patients with recurrent ovarian cancer and inoperable, locally advanced or metastatic pancreatic cancer, which bears deleterious germline or somatic mutations in BRCA1, BRCA2, or HRD (homologous recombination deficiency) -related genes.

Based on reported preclinical and clinical efficacy of Mitomycin C in BRCA-mutated tumors, and together with the demonstrated improved safety profile of Promitil in humans, it is expected that this liposomal formulation will have a favorable therapeutic index and significant clinical antitumor activity in patients with tumors bearing BRCA 1/2 and/or PALB2 mutations.

Read the detailed description

The study will include a Screening, Treatment Phase and Long-Term Follow-up (LTFU) Phase. Upon signing the informed consent form, all subjects will undergo screening procedures to assess eligibility within 21 days prior to receiving study drug. Eligible subjects will be intravenously (IV) administered 2.0 mg/kg Promitil on Day 1 of each 28-day cycle, for up to 6 cycles. Subjects who complete the 6-cycle Treatment Phase have the option to continue to receive Promitil until disease progression, death, unacceptable toxicity or withdrawal of consent. During the 6-month Treatment Phase, safety assessments will be conducted at each study visit (Days 1, 2, 4,8 and 14 of Cycle 1, Day 1 of Cycle 2 and Cycles 4 and beyond and Days 1, 2 4,and 8 of Cycle 3). Safety will be assessed by measurement of weight, physical examinations, vital signs, ECG recordings, blood chemistry, hematologic and urinalysis parameters, and review of Adverse and Serious Adverse events (SAEs) and concomitant medications. Response will be assessed by CT/MRI/PET-CT scans and biomarker levels, with imaging conducted every 12 weeks (every 3 treatment cycles).For patients who stopped receiving Promitil for any reason other than disease progression, response will continue to be assessed every 12 weeks, until disease progression, death or withdrawal of consent, but no later than 1 year from first dose of Promitil. Once study treatment ends, all subjects will be followed up long-term, with survival status assessed every 3 months for up to 1 year or until death, the earlier of the two.

Being tested
Promitil
Keywords
Solid tumors, metastatic, inoperable, BRCA mutations
Medical subject headings
Ovarian Neoplasms, Neoplasm Metastasis

What participants receive

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

  • PromitilDrug

    Also called Pegylated Liposomal Mitomycin-C Lipid-based Prodrug

    The 10 patients recruited in each of the cohorts will receive intravenously (IV) administered 2.0 mg/kg Promitil on Day 1 of each 28-day cycle, for up to 6 cycles. Subjects who complete the 6-cycle Treatment Phase have the option to continue to receive Promitil until disease progression, death, unacceptable toxicity or withdrawal of consent.

Study groups in NCT06478862
Study groupRoleWhat they receive
Pancreatic cancerExperimentalEligible subjects with pancreatic cancer will be intravenously (IV) administered 2.0 mg/kg Promitil on Day 1 of each 28-day cycle, for up to 6 cycles. Each cycle may be extended for up to 3 additional weeks (i.e., up to a total of 7 weeks from previous Day 1), if tolerability issues arise.
Receives: Drug: Promitil
Ovarian cancerExperimentalEligible subjects with ovarian cancer will be intravenously (IV) administered 2.0 mg/kg Promitil on Day 1 of each 28-day cycle, for up to 6 cycles. Each cycle may be extended for up to 3 additional weeks (i.e., up to a total of 7 weeks from previous Day 1), if tolerability issues arise.
Receives: Drug: Promitil

What is being measured

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

  1. Progression-free survival (PFS) rate at Month 6

    defined as the proportion of patients who are alive and without radiological or clinical progression, based on RECIST 1.1

    Measured: 24 weeks

Secondary outcomes (6)

  1. Incidence, severity, and duration of treatment-emergent adverse events (TEAEs)

    TEAEs assessed by NCI Common Toxicity Criteria Adverse Events (CTCAE v5.0).

    Measured: 30 weeks

  2. Objective response rate (ORR):

    ORR: proportion of patients with partial or complete response (PR or CR, respectively), based on RECIST 1.1 criteria

    Measured: 24 weeks

  3. Duration of response (DOR)

    DOR: defined as the time from first evidence of confirmed objective response to the first occurrence of disease progression or death from any cause

    Measured: 24 weeks

  4. Disease control rate (DCR)

    DCR :defined as proportion of subjects alive and free of disease progression with either complete response (CR), partial response (PR) or stable disease (SD)

    Measured: 24 weeks

  5. Overall survival (OS):

    OS: time from first dose of Promitil to date of death from any cause

    Measured: 52 weeks

  6. To assess the changes in tumor biomarker levels following treatment with Promitil

    Changes from baseline in CA19-9, CA125, CA15.3 and/or CEA blood levels

    Measured: 24 weeks

Timeline

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

  1. First posted27 Jun 2024
  2. Study start13 Jun 2024
  3. Primary completion2 Jan 2026
  4. Study completion2 Jan 2026

Why it stopped: Sponsor decision

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
Non-randomised
Intervention model
Parallel groups
Model description
There will be 2 cohorts with up to 10 patients per cohort indication (ovarian/pancreatic). Eligible patients will be assigned in parallel to receive 6 cycles of Promitil treatment.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06478862
Sponsor's protocol ID
PROM-2301
Status last verified
Jan 2026
First submitted
17 Jun 2024
Last updated
9 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gabizon A, Shmeeda H, Tahover E, Kornev G, Patil Y, Amitay Y, Ohana P, Sapir E, Zalipsky S. Development of Promitil(R), a lipidic prodrug of mitomycin c in PEGylated liposomes: From bench to bedside. Adv Drug Deliv Rev. 2020;154-155:13-26. doi: 10.1016/j.addr.2020.07.027. Epub 2020 Aug 7.

    PubMed 32777239

  • Gabizon AA, Tahover E, Golan T, Geva R, Perets R, Amitay Y, Shmeeda H, Ohana P. Pharmacokinetics of mitomycin-c lipidic prodrug entrapped in liposomes and clinical correlations in metastatic colorectal cancer patients. Invest New Drugs. 2020 Oct;38(5):1411-1420. doi: 10.1007/s10637-020-00897-3. Epub 2020 Jan 18.

    PubMed 31955309

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Promitil in people with Cancer of Ovary and Pancreatic Ductal Adenocarcinoma, run by Lipomedix Pharmaceuticals Inc. at 6 sites in Israel.

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 11 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: stopped early, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Israel. 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?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

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?

Progression-free survival (PFS) rate at Month 6 (time frame: 24 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 NCT06478862, which also lists 2 linked publications.

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 9 Jan 2026.

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