Ovarian CancerPhase 1/2MAIA-ovarianNCT06888921
A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer
A Phase 1/2 study testing COM701 and Normal Saline in people with Ovarian Cancer and Ovarian Cancer Recurrent, run by Compugen Ltd at 27 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Cancer Recurrent
- What is being tested?
- COM701 and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 21 Jul 2025to Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- 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).
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
United States13 sites
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
Massachusetts General Hospital
Boston, Massachusetts, 02114
Levine Cancer Institute
Charlotte, North Carolina, 28204
UVA Comprehensive Cancer Center
Charlottesville, Virginia, 22903
The University of Chicago Medical Center
Chicago, Illinois, 60637
Corewell Health
Grand Rapids, Michigan, 49503
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Hilliard, Ohio, 43026
Memorial Sloan Kettering Cancer Center- Main Campus
New York, New York, 10065
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
UPMC Magee- Womens Hospital
Pittsburgh, Pennsylvania, 15213
University of Rochester Medical Center
Rochester, New York, 14642
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Northwestern Memorial Hospital
Warrenville, Illinois, 60555
France8 sites
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
Besançon, France, 25000
Centre Oscar Lambret
Lille, 59000
Institut Paoli-Calmettes
Marseille, 13009
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Centre Eugene Marquis
Rennes, 35042
Institut de Cancerologie de l'Ouest- Site Rene Gauducheau
Saint-Herblain, 44805
Oncopole Claudius Regaud
Toulouse, France, 31059
Gustave Roussy
Villejuif, 94800
Israel6 sites
Assuta Medical Center
Ashdod, 7747629
Rambam Health Care Campus
Haifa, 3109601
The Edith Wolfson Medical Center
Holon, 5822012
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah, University Hospital Ein Kerem
Jerusalem, 9112001
The Chaim Sheba Medical Center
Ramat Gan, 5265601
About this study
Official title: An Adaptive Clinical Platform Trial to Evaluate the Safety and Efficacy of COM701 as Monotherapy or Combination Therapy as Maintenance Therapy in Participants With Relapsed Platinum Sensitive Ovarian Cancer (PSOC)
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:
Read more
- 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,
Read the detailed description
Trial CPG-01-201 is an adaptive-platform trial comprised of multiple sub-studies.
Sub-study 1 will be a parallel group, double-blind, randomized placebo-controlled trial in which participants will be randomized in a 1:2 ratio to either placebo (a look-alike substance that contains no drug) or COM701 treatment arms. This means that there is a 33% chance of being placed in the group getting placebo and a 67% chance of being placed in the group that will get the experimental COM701 antibody.
Subsequent sub-studies will evaluate COM701 in combination with other anti-cancer drugs.
- Conditions
- Ovarian Cancer, Ovarian Cancer Recurrent
- Being tested
- COM701, Normal Saline
- Keywords
- maintenance therapy, relapsed platinum sensitive ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COM701Drug
COM701 will be administered via intravenous (IV) infusion once every 3 weeks.
Normal SalineDrug
Saline will be administered via intravenous (IV) infusion once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| COM701 | Experimental | Not described Receives: Drug: COM701 |
| Normal Saline | Placebo comparator | Not described Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of COM701 as a single agent on progression free survival when administered as a maintenance regimen in participants with relapsed PSOC
Progression free survival in COM701-treated participants compared to placebo-treated participants
Measured: From the date of randomization until the date of disease progression, or date of death from any cause whichever occurs first, assessed up to 2 years
Secondary outcomes (2)
To evaluate the safety and tolerability of the COM701 as a single agent when administered as a maintenance regimen in participants with relapsed PSOC
Number of participants with adverse events in the COM701 treatment arm compared to the placebo treatment arm
Measured: From randomization up to 90 days post last cycle of study treatment (each cycle is 3 weeks; study treatment may continue up to 2 years).
To evaluate the effect of COM701 as a single agent on other efficacy endpoints when administered as a maintenance regimen in participants with relapsed PSOC
Time to the initiation of a new anti-cancer treatment in COM701-treated participants compared to placebo-treated participants
Measured: From date of randomization until the date of the initiation of a new anti-cancer treatment, or date of death from any cause whichever occurs first, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start21 Jul 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an adaptive platform trial enabling the evaluation of COM701 initially as a single agent compared to placebo in relapsed PSOC. This will enable the evaluation of the effects of COM701 as a single agent followed by the potential to adjust the trial to evaluate combinations with COM701. A data monitoring committee will review all safety and efficacy data on a regular basis and will make recommendations regarding study unblinding and timing to start additional sub-studies evaluating COM701 in combination with other anti-cancer drugs. An interim analysis will be conducted when approximately 60 participants in sub-study 1 have been followed for approximately 9 months.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Compugen Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888921
- Sponsor's protocol ID
- CPG-01-201
- Acronym
- MAIA-ovarian
- Status last verified
- Sep 2026
- First submitted
- 12 Mar 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Clinical Platform Trial to Evaluate the Safety and Efficacy of COM701 as Monotherapy or Combination Therapy as Maintenance Therapy in Participants With Relapsed Platinum Sensitive Ovarian Cancer (PSOC)
- ClinicalTrials.gov ID
- NCT06888921
- Acronym / sponsor ID
- MAIA-ovarian / CPG-01-201
- Conditions
- Ovarian Cancer, Ovarian Cancer Recurrent
- Keywords
- maintenance therapy, relapsed platinum sensitive ovarian cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Compugen LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Detailed description
Trial CPG-01-201 is an adaptive-platform trial comprised of multiple sub-studies.
Sub-study 1 will be a parallel group, double-blind, randomized placebo-controlled trial in which participants will be randomized in a 1:2 ratio to either placebo (a look-alike substance that contains no drug) or COM701 treatment arms. This means that there is a 33% chance of being placed in the group getting placebo and a 67% chance of being placed in the group that will get the experimental COM701 antibody.
Subsequent sub-studies will evaluate COM701 in combination with other anti-cancer drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is an adaptive platform trial enabling the evaluation of COM701 initially as a single agent compared to placebo in relapsed PSOC. This will enable the evaluation of the effects of COM701 as a single agent followed by the potential to adjust the trial to evaluate combinations with COM701. A data monitoring committee will review all safety and efficacy data on a regular basis and will make recommendations regarding study unblinding and timing to start additional sub-studies evaluating COM701 in combination with other anti-cancer drugs. An interim analysis will be conducted when approximately 60 participants in sub-study 1 have been followed for approximately 9 months.
| Arm | Type | Receives |
|---|---|---|
| COM701 | Experimental | Drug: COM701 |
| Normal Saline | Placebo comparator | Drug: Normal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COM701COM701 will be administered via intravenous (IV) infusion once every 3 weeks. | Drug | COM701 |
| Normal SalineSaline will be administered via intravenous (IV) infusion once every 3 weeks | Drug | Normal Saline |
Primary outcome
To evaluate the effect of COM701 as a single agent on progression free survival when administered as a maintenance regimen in participants with relapsed PSOC
Time frame: From the date of randomization until the date of disease progression, or date of death from any cause whichever occurs first, assessed up to 2 years
Progression free survival in COM701-treated participants compared to placebo-treated participants
2 secondary outcomes
To evaluate the safety and tolerability of the COM701 as a single agent when administered as a maintenance regimen in participants with relapsed PSOC
Time frame: From randomization up to 90 days post last cycle of study treatment (each cycle is 3 weeks; study treatment may continue up to 2 years).
To evaluate the effect of COM701 as a single agent on other efficacy endpoints when administered as a maintenance regimen in participants with relapsed PSOC
Time frame: From date of randomization until the date of the initiation of a new anti-cancer treatment, or date of death from any cause whichever occurs first, assessed up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing COM701 and Normal Saline in people with Ovarian Cancer and Ovarian Cancer Recurrent, run by Compugen Ltd at 27 sites in 3 countries.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, France, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
To evaluate the effect of COM701 as a single agent on progression free survival when administered as a maintenance regimen in participants with relapsed PSOC (time frame: From the date of randomization until the date of disease progression, or date of death from any cause whichever occurs first, assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.