NeoplasmPhase 1NCT06759649
A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies
A Phase 1 study testing COM503 and Zimberelimab in people with Neoplasm and Cancer, Malignant Tumors, run by Compugen Ltd at 11 sites in 2 countries.
Trial summary
The overall goal of this first-in-human (FIH) clinical trial is to learn about the safety and dosing of COM503 when given alone or in combination with zimberelimab in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Cancer, Malignant Tumors
- What is being tested?
- COM503 and Zimberelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 7 Jan 2025to 22 Nov 2027
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with histologically/cytologically confirmed advanced recurrent or metastatic solid tumor malignancy
- Part 1 (dose escalation): Participants must have had disease progression on or following all available standard of care (SOC) therapies known to confer clinical benefit.
- Part 2 (dose expansion): Participants may be enrolled following disease progression that has progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized SOC.
- Participants must have a solid tumor measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment
Who cannot join
- History of another malignancy within 2 years prior to the first trial intervention administration (unless the malignancy was treated with curative intent with low risk of recurrence [e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar] which are allowed to enroll).
- Therapy with Immunosuppressive doses of systemic medications, such as steroids (doses >10 mg/day prednisone or equivalent daily) within 2 weeks before trial intervention administration
- Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD).
- Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
- Ascites or pleural effusion that is symptomatic and/or requiring drainage within 2 weeks prior to the first trial intervention administration.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or participants with human immunodeficiency virus (HIV).
- Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the participant's participation in the trial.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 0221502215
6179757423, aposner1@bidmc.harvard.edu
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Mohammed Salkeni, 7037834510, msalkeni@nextoncology.com
- Recruiting
The West Clinic, PLCC dba West Cancer Center
Germantown, Tennessee, 38138
Manager of Phase 1 Research, 9016830055, nholloway@westclinic.com
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Manish Sharma, 6169545554, manish.sharma@startmidwest.com
- Recruiting
Yale- New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, 06510
Study Coordinator, 2038154124, omowunmi.afolabi@yale.edu
- Recruiting
NEXT Oncology San Antonio
San Antonio, Texas, 78229
David Sommerhalder, 2105809500, dsommerhalder@nextoncology.com
- Recruiting
START- San Antonio
San Antonio, Texas, 78229
HOPE Team Primary Site Contact, 210-593-5250, hopeteam@startresearch.com
Drew Rasco
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, Israel, 3109601
Sudy Coordinator, 97247776238, l_rapaport@rambam.health.gov.il
- Recruiting
Hadassah University Medical Center- Ein Kerem
Jerusalem, Israel, 9112001
Study Coordinator, 972509010225, ORITCOHEN@hadassah.org.il
- Recruiting
Rabin Medical Center
Petah Tikva, Israel, 4941492
Study Coordinator, 972524632668, yafitso1@clalit.org.il
- Recruiting
The Chaim Sheba Medical Center
Ramat Gan, Israel, 5465601
Study Coordinator, 972353304498, ilanit.redinsky@sheba.health.gov.il
About this study
Official title: A First-in-Human, Phase 1 Dose Escalation and Dose Expansion Trial to Assess the Safety and Tolerability of COM503 as Monotherapy and in Combination Therapy in Participants With Advanced Solid Malignancies
The overall goal of this first-in-human (FIH) clinical trial is to learn about the safety and dosing of COM503 when given alone or in combination with zimberelimab in participants with advanced solid tumors.
The primary objectives of this study are:
- To assess the safety and tolerability of COM503 as monotherapy and COM503 in combination with zimberelimab in participants with advanced solid tumors.
- To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of COM503 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.
- Conditions
- Neoplasm, Cancer, Malignant Tumors
- Being tested
- COM503, Zimberelimab
- Keywords
- first-in-human, oncology, monoclonal antibody, immunotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COM503Drug
Intravenous Infusion
ZimberelimabDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1, A-1 | Experimental | Monotherapy Dose Escalation Receives: Drug: COM503 |
| Part 1, A-2 | Experimental | Backfill Receives: Drug: COM503 |
| Part 1, B | Experimental | Dose escalation, COM503 in combination with a fixed dose of zimberelimab. Receives: Drug: COM503; Drug: Zimberelimab |
| Part 2, A | Experimental | Dose expansion, COM503 monotherapy Receives: Drug: COM503 |
| Part 2, B | Experimental | Dose expansion, COM503 in combination with a fixed dose of zimberelimab. Receives: Drug: COM503; Drug: Zimberelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
Number of participants in monotherapy cohorts with treatment-related adverse events as assessed by CTCAE v4.0
Measured: from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
Number of participants in monotherapy cohorts with treatment-related serious adverse events as assessed by CTCAE v4.0
Measured: from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
Number of participants in combination cohorts with treatment-related adverse events as assessed by CTCAE v4.
Measured: from the first dose of COM503 in combination with zimberelimab to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
Number of participants in combination cohorts with treatment-related serious adverse events as assessed by CTCAE v4.
Measured: from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start7 Jan 2025
- Primary completion22 Nov 2027 (estimated)
- Study completion22 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Compugen Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759649
- Sponsor's protocol ID
- CPG-05-101
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1 Dose Escalation and Dose Expansion Trial to Assess the Safety and Tolerability of COM503 as Monotherapy and in Combination Therapy in Participants With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT06759649
- Acronym / sponsor ID
- CPG-05-101
- Conditions
- Neoplasm, Cancer, Malignant Tumors
- Keywords
- first-in-human, oncology, monoclonal antibody, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Compugen LtdIndustry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 22 Nov 2027 (estimated)
- Study completion
- 22 Nov 2027 (estimated)
- First posted
- 6 Jan 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 overall goal of this first-in-human (FIH) clinical trial is to learn about the safety and dosing of COM503 when given alone or in combination with zimberelimab in participants with advanced solid tumors.
The primary objectives of this study are:
- To assess the safety and tolerability of COM503 as monotherapy and COM503 in combination with zimberelimab in participants with advanced solid tumors.
- To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of COM503 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1, A-1 | Experimental | Drug: COM503Monotherapy Dose Escalation |
| Part 1, A-2 | Experimental | Drug: COM503Backfill |
| Part 1, B | Experimental | Drug: COM503, Drug: ZimberelimabDose escalation, COM503 in combination with a fixed dose of zimberelimab. |
| Part 2, A | Experimental | Drug: COM503Dose expansion, COM503 monotherapy |
| Part 2, B | Experimental | Drug: COM503, Drug: ZimberelimabDose expansion, COM503 in combination with a fixed dose of zimberelimab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with histologically/cytologically confirmed advanced recurrent or metastatic solid tumor malignancy
- Part 1 (dose escalation): Participants must have had disease progression on or following all available standard of care (SOC) therapies known to confer clinical benefit.
- Part 2 (dose expansion): Participants may be enrolled following disease progression that has progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized SOC.
- Participants must have a solid tumor measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment
Key exclusion criteria (7 listed)
- History of another malignancy within 2 years prior to the first trial intervention administration (unless the malignancy was treated with curative intent with low risk of recurrence [e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar] which are allowed to enroll).
- Therapy with Immunosuppressive doses of systemic medications, such as steroids (doses >10 mg/day prednisone or equivalent daily) within 2 weeks before trial intervention administration
- Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD).
- Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
- Ascites or pleural effusion that is symptomatic and/or requiring drainage within 2 weeks prior to the first trial intervention administration.
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 |
|---|---|---|
| COM503Intravenous Infusion | Drug | Part 1, A-1, Part 1, A-2, Part 1, B, Part 2, A, Part 2, B |
| ZimberelimabIntravenous infusion | Drug | Part 1, B, Part 2, B |
Primary outcome
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
Time frame: from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
Number of participants in monotherapy cohorts with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
Time frame: from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
Number of participants in monotherapy cohorts with treatment-related serious adverse events as assessed by CTCAE v4.0
To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
Time frame: from the first dose of COM503 in combination with zimberelimab to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
Number of participants in combination cohorts with treatment-related adverse events as assessed by CTCAE v4.
To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
Time frame: from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
Number of participants in combination cohorts with treatment-related serious adverse events as assessed by CTCAE v4.
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 12 Aug 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.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COM503 and Zimberelimab in people with Neoplasm and Cancer, Malignant Tumors, run by Compugen Ltd at 11 sites in 2 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, 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 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?
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?
Contact Michelle Chief Medical Officer, MD (+14153734034, michellebm@cgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies. (time frame: from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.). The study lists 4 primary outcomes in all. 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 12 Aug 2026.