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

NCT05684731 | Recruiting Phase 1

• 1 other identifier: 2023-TJ-KM1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

KM1; oncolytic virus; immunotherapy

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity (DLT)

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

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

• Adverse events (AEs) and serious adverse events (SAEs)

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

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

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

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

Secondary Outcomes (7)

• Virus particles

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

• Virus coding genes

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

• Anti-Drug Antibodies (ADA)

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

• Progression Free Survival (PFS) by RECIST 1.1

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

• Objective Response Rate (ORR) by RECIST 1.1

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

Study Arms (1)

Experimental: KM1 + Chemotherapy

EXPERIMENTAL

Biological: 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.

Biological: KM1; Drug: Chemotherapy

Interventions

KM1 BIOLOGICAL

Administer via intraperitoneal infusion for 3 or 6 doses Q3D.

Experimental: KM1 + Chemotherapy

Chemotherapy DRUG

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.

Experimental: KM1 + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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:

Sponsors & Collaborators

• Tongji Hospital: lead
• Qilu Hospital of Shandong University: collaborator
• People's Hospital of Quzhou: collaborator
• Shenzhen Hua Yao Kang Ming Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Qinglei Gao, MD. PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinglei Gao, MD. PhD

CONTACT

15391566981; qingleigao@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 13, 2023
• Study Start: February 1, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)