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Ovarian CancerPhase 1K19017-004NCT05684731

Safety and Efficacy of KM1 in Subjects With Recurrent or Refractory Ovarian Cancer

A Phase 1 study testing KM1 and Chemotherapy in people with Ovarian Cancer, run by Tongji Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine if KM1 is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer, and explore the Recommend Phase 2 Dose (RP2D) of KM1 in the treatment of patients with recurrent or refractory ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
KM1 and Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Feb 2023to 1 Jun 2026
Phase
Phase 1
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytopathology confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, except mucinous cancer.
  • Relapsed/refractory subjects who failed to receive systemic treatment (at least one standard platinum containing regimen); Note: If the disease relapses, there should be evidence showing imaging or clinical progress (such as cytological report of new ascites or pleural effusion). Only the increase of CA125 cannot be used as the standard of disease recurrence.
  • Performance status ECOG of 0 or 1.
  • Life expectancy of at least 3 months.
  • Toxicities of prior therapies have not been resolved to Grade 1 or baseline (except for alopecia, pigmentation or other toxicity considered as no safety risk to the subject in the study).
  • At least 1 measurable target lesion by RECIST 1.1.
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  • Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.
  • Pregnancy test results within 14 days before the treatment were negative. Subjects of childbearing age must agree to use at least one medically approved contraceptive measure (such as surgical sterilization, oral contraceptives, intrauterine devices, sexual desire control, etc.) during the study treatment and at least 6 months after the last trial drug treatment;
  • Subjects voluntarily participated in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Who cannot join

  • • Central nervous system (CNS) metastasis or cancerous meningitis (Note: Subjects with treated CNS metastases may participate in this trial if the subject is neurologically stable ≥3 months).
  • Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal/squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast.
  • Received any of the following treatments within a specific time frame prior to enrollment:
  • Have received surgery of Grade II or above within 4 weeks (Whether or not related to tumor), except minimally invasive surgery under gastrointestinal endoscopy;
  • Have received radiotherapy within 2 weeks (the investigator can judge the appropriate time of enrollment according to the patient's toxicity recovery after radiotherapy);
  • Within 4 weeks or participating in other therapeutic/interventional clinical studies;
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  • Have received local anti-tumor treatment within 4 weeks;
  • Allergic to the test drug or its active ingredients and excipients.
  • Has had severe allergic reaction after receiving smallpox vaccine in the past.
  • Has a history of severe skin diseases requiring systemic treatment within 2 years, such as eczema, atopic dermatitis, burns, seborrheic dermatitis, psoriasis, severe acne, etc.
  • Has had an allogenic tissue/solid organ transplant.
  • Active infection or fever of unknown cause (>38.5 ℃).
  • Active pulmonary tuberculosis (TB) who are receiving anti tuberculosis treatment or who have received anti tuberculosis treatment within 1 year before screening;
  • Positive anti-HIV (+) or anti-HCV (+) or syphilis specific antibody (TPHA) or active hepatitis B.
  • Has a history of serious cardiovascular or cerebrovascular diseases, including but not limited to:
  • New York Heart Association (NYHA) congestive heart failure of grade III or above;
  • Serious arrhythmia requiring drug treatment;
  • Acute myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, and stenting occurred within 6 months;
  • Left ventricular ejection fraction (EF)<60%;
  • QTcF interval ≥ 460 ms, or there are risk factors of torsade de pointes ventricular tachycardia, such as hypokalemia, family history of long QT syndrome or family history of arrhythmia (such as preexcitation syndrome);
  • Presence of uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic BP>100 mmHg).
  • Active autoimmune diseases such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autohemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis), but the following conditions are allowed to enter the screening: type I diabetes, hypothyroidism that can be controlled only through alternative treatment, skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia).
  • Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis > once every 14 days.
  • Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.
  • Active gastrointestinal bleeding.
  • Accompanied by unstable mental illness, alcohol abuse, drug abuse or drug abuse.
  • Other conditions that investigator considers unsuitable for this study.

Trial locations and contacts

1 site in 1 country.

Qinglei Gao, MD. PhD contact

15391566981

qingleigao@hotmail.com

China1 site, 1 recruiting

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Qinglei Gao, PhD, MD, +86-13871127473, qingleigao@hotmail.com

    Qinglei Gao, PhD, MD

    Recruiting

Other trials in China

About this study

Official title: A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Tolerance and Preliminary Efficacy of KM1 Oncolytic Vaccinia Virus Injection Combined With Chemotherapy in Subjects With Recurrent or Refractory Ovarian Cancer

The purpose of this study is to determine if KM1 is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer, and explore the Recommend Phase 2 Dose (RP2D) of KM1 in the treatment of patients with recurrent or refractory ovarian cancer.

Read the detailed description

Oncolytic virus therapy is a kind of immunotherapy that can selectively infect and kill tumor cells without damaging normal cells. It has shown good therapeutic effects in the treatment of various types of tumors. KM1 is a genetically modified recombinant vaccinia virus, which has good therapeutic effect on many solid tumors, including ovarian cancer. This study includes Phase Ia and Phase Ib. In the Phase Ia study, subjects will receive three doses intraperitoneal infusion of KM1 followed by chemotherapy. In the Phase Ib study, subjects will receive six doses intraperitoneal infusion of KM1 preceding chemotherapy. Subjects will be followed in the study for 6 months after last dose of chemotherapy.

Conditions
Ovarian Cancer
Being tested
KM1, Chemotherapy
Keywords
KM1, oncolytic virus, immunotherapy
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • KM1Biological

    Administer via intraperitoneal infusion for 3 or 6 doses Q3D.

  • ChemotherapyDrug

    Physician's Choice of carboplatin (preferred) or cisplatin，gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin，with or without bevacizumab.

    Administer beginning in Week 5 or Week 6.

Study groups in NCT05684731
Study groupRoleWhat they receive
Experimental: KM1 + ChemotherapyExperimentalBiological: KM1 Administer via intraperitoneal infusion for 3 or 6 doses Q3D. Drug: Chemotherapy: Physician's Choice of carboplatin (preferred) or cisplatin，gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin，with or without bevacizumab. Administer beginning in Week 5 or Week 6.
Receives: Biological: KM1; Drug: Chemotherapy

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Type and incidence of dose-limiting toxicity (DLT) by dose group

    Measured: From baseline during treatment to 21 days following last dose of KM1.

  2. Adverse events (AEs) and serious adverse events (SAEs)

    Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group

    Measured: From baseline during treatment to 21 days following last dose of KM1

  3. Maximum tolerable dose (MTD)/ Recommended Phase II Dose (RP2D）

    Measured: From baseline during treatment to 21 days following last dose of KM1.

Secondary outcomes (7)

  1. Virus particles

    Level of virus particles tested by plaque assay in blood, body fluids (urine, feces and saliva), peritoneal fluid (if any), and tumor tissue (if any) at baseline and during treatment period.

    Measured: From baseline during treatment to 21 days following last dose of KM1.

  2. Virus coding genes

    Level of virus coding genes tested by PCR assay in blood, body fluids (urine, feces and saliva), peritoneal fluid (if any), and tumor tissue (if any) at baseline and during treatment period.

    Measured: From baseline during treatment to 21 days following last dose of KM1.

  3. Anti-Drug Antibodies (ADA)

    Titer of positive ADA against KM1 at baseline and during treatment period.

    Measured: From baseline during treatment to 21 days following last dose of KM1.

  4. Progression Free Survival (PFS) by RECIST 1.1

    Time from study treatment initiation to the first occurrence of disease progression or death (of any cause).

    Measured: From date of randomization up to 6 months following last dose of chemotherapy.

  5. Objective Response Rate (ORR) by RECIST 1.1

    The ratio of the sum of Complete Response \& Partial Response divided by the number of participants from the start of treatment to confirmation of response.

    Measured: From date of randomization up to 6 months following last dose of chemotherapy.

  6. Disease Control Rate (DCR) RECIST 1.1

    The ratio of the sum of Complete Response \& Partial Response \& Stable Disease divided by the number of participants from the start of treatment to confirmation of response

    Measured: From date of randomization up to 6 months following last dose of chemotherapy.

  7. CA-125 Response

    Level of CA-125 (UI/ml) at baseline and after treatment measured by Enzyme Linked Immunosorbent Assay (ELISA).

    Measured: From date of randomization up to 6 months following last dose of chemotherapy.

Timeline

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

  1. First posted13 Jan 2023
  2. Study start1 Feb 2023
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study is a multicenter, open label, non-controlled, exploratory study. The "3+3" dose escalation design will be implemented to evaluate the safety and tolerability of KM1 in the treatment of subjects with recurrent or refractory ovarian cancer.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05684731
Sponsor's protocol ID
2023-TJ-KM1
Acronym
K19017-004
Status last verified
Aug 2024
First submitted
3 Jan 2023
Last updated
13 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KM1 and Chemotherapy in people with Ovarian Cancer, run by Tongji Hospital at 1 site in China.

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 9 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Qinglei Gao, MD. PhD (15391566981, qingleigao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: From baseline during treatment to 21 days following last dose of KM1.). The study lists 3 primary outcomes in all. 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 NCT05684731.

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 13 Aug 2024.

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