Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Compugen Ltd · Industry
Who this trial is looking for
This trial is looking for women with relapsed platinum sensitive ovarian cancer. Participants will receive an experimental treatment called COM701 and undergo regular health checks and tests over several visits.
Are You a Good Fit for This Trial?
Rules you outActive hepatitis B virusActive hepatitis C virusActive HIVSerious allergic reactions to monoclonal antibodies
You may be able to join if
I have relapsed platinum sensitive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
I have completed at least 2 courses of platinum-containing therapy.
I have had at least 4 cycles of platinum-containing chemotherapy before joining the study and my tumor responded to treatment.
I have previously received maintenance therapy with bevacizumab or a PARP inhibitor and am not eligible or have chosen not to continue with those treatments.
I have recovered from side effects of previous treatments.
You may not be able to join if
I have had 4 or more lines of cytotoxic chemotherapy in total.
I am currently taking immunosuppressive doses of medications like steroids.
I have had previous treatments with any checkpoint inhibitors.
I have active liver metastases at the start of this chemotherapy.
I have had drainage of fluid in the abdomen during recent treatments.
I had a bowel obstruction in the last 6 weeks.
I have active central nervous system metastases.
I am currently pregnant, breastfeeding, or planning to become pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants with Relapsed Platinum Sensitive Ovarian Cancer. It will also learn about the safety of COM701.
The main questions the trial aims to answer are:
* Does COM701, when used as a maintenance treatment, stop or slow the progression of ovarian cancer?
* Does COM701 d…
The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants with Relapsed Platinum Sensitive Ovarian Cancer. It will also learn about the safety of COM701.
The main questions the trial aims to answer are:
* Does COM701, when used as a maintenance treatment, stop or slow the progression of ovarian cancer?
* Does COM701 delay the time to needing a new anti-cancer treatment?
* What side effects do participants have when taking COM701?
Participants will:
* Visit the clinic once every 3 weeks during which the study treatment will be administered intravenously
* Undergo various tests and procedures to monitor general health throughout the trial including physical examinations, vital sign measurements (heart rate, blood pressure, breathing, and body temperature), weight measurements, electrocardiography (ECG), blood and urine tests and pregnancy tests if relevant.
* Undergo various tests and procedures to assess disease response throughout the trial including tumor imaging by CT scans or MRI to assess the tumor, its location, and size, and the testing of a sample of tumor tissue (from a prior biopsy or a fresh biopsy if feasible, to evaluate tumor response to treatment and to measure levels of tumor markers,
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
* Has completed at least 2 previous courses (i.e. lines) of platinum-containing therapy
* For the last chemotherapy course prior to being randomized into the study, mu…
Inclusion Criteria:
* Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
* Has completed at least 2 previous courses (i.e. lines) of platinum-containing therapy
* For the last chemotherapy course prior to being randomized into the study, must have had a minimum of 4 cycles of a platinum containing regimen and achieved a partial or complete tumor response.
* Has received prior maintenance therapy with bevacizumab or a PARP inhibitor if eligible and is not a candidate for, or has declined in writing, bevacizumab or PARP inhibitor therapy.
* Have recovered from toxicities of prior chemotherapy or other therapy (to grade 1 or less, except for alopecia and neuropathy recovered to a ≤grade 2).
Exclusion Criteria:
* Has had 4 or more lines of cytotoxic chemotherapy in total
* Is being treated with immunosuppressive doses of systemic medications, such as steroids within 2 weeks before study drug administration
* Has had prior treatment with PD-1, PD-L1, anti-PVRIG, TIGIT or any other check point inhibitors
* Presence of radiographic or biopsy proven liver metastases at the beginning or completion of current line of platinum-based chemotherapy.
* Drainage of ascites during last 2 cycles of last chemotherapy or any time after completion of the last chemotherapy regimen.
* Bowel obstruction in the 6 weeks prior to randomization.
* Have known active central nervous system metastases and/or carcinomatous meningitis / leptomeningeal carcinomatosis.
* Has active hepatitis B virus (HBV) or hepatitis C virus (HCV), or subjects with human immunodeficiency virus (HIV).
* Has active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
* Has received a live viral vaccine within 30 days of planned start of study treatment or requiring a live vaccine during the study.
* Has a history of severe allergic, anaphylactic, or other hypersensitivity reactions to a human or humanized monoclonal antibody (mAb) or allergy to any excipients in the investigational products.
* Has any serious or unstable concomitant systemic disorder
* Has any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the subject inappropriate for entry into the study.
* Is currently participating in or have participated in a clinical study and received an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment.
* Is pregnant or breastfeeding or planning to become pregnant during the period of the study.
Contacts
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