Advanced CancerPhase 1NCT04354246
COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
A Phase 1 study testing Dose escalation: COM902 monotherapy., Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) and Cohort expansion: COM902 (RDFE) monotherapy. in people with Advanced Cancer and Ovarian Cancer, run by Compugen Ltd at 9 sites in United States.
Trial summary
Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Ovarian Cancer, Lung Cancer
- What is being tested?
- Dose escalation: COM902 monotherapy., Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) and Cohort expansion: COM902 (RDFE) monotherapy.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 9 sitesUnited States
- Study dates
- 31 Mar 2020to 1 Apr 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histologically/cytologically confirmed advanced malignancy (solid tumor) who must have exhausted all available standard therapy, or not a candidate for standard therapy.
- Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- For Triplet combination MSS-CRC:
- Histologically confirmed adenocarcinoma of the colon/rectum
- Stage IV disease
Show all 13Show fewer
- MSS-CRC status by an FDA approved test
- Disease progression with no more than 3 prior lines of treatment including fluroropyrimidines, irinotecan, and oxaliplatin
- For Triplet combination ovarian cancer:
- Advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
- Platinum resistant ovarian cancer (PROC) defined as disease recurrence < 6 months after completion of a platinum-containing regimen: Patients with primary platinum refractory disease are ineligible. Primary platinum refractory disease is defined as progression of disease prior to completion of 1st line platinum therapy or immediately following (≤ 3 months following last date of chemotherapy)
- Received ≤3 prior lines for PROC; maintenance bevacizumab or PARP are not included as a line of therapy
- Subjects who have received PARP inhibitor therapy are eligible
Who cannot join
- Prior treatment with a TIGIT inhibitor.
- Prior treatment with an inhibitor of PVRIG
- Symptomatic interstitial lung disease or inflammatory pneumonitis.
- History of immune-related events that required immunotherapy treatment discontinuation
- For Triplet combination expansion cohorts (MSS-CRC and PROC): Prior treatment with an anti-PD-1/PD-L1/2, anti-CD96 antibody, anti-OX-40 antibody, anti-CD137 antibody, anti-LAG3, anti-TIM3, anti-CTLA4 antibody.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Massachusetts General Hospital.
Boston, Massachusetts, 02114
The Ohio State University Comprehensive Cancer Center.
Columbus, Ohio, 43210
Mary Crowley Cancer Research
Dallas, Texas, 75230
START Midwest.
Grand Rapids, Michigan, 49503
MD Anderson Cancer Center.
Houston, Texas, 77030
The University of Tennessee WEST Cancer Center.
Memphis, Tennessee, 38138
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
The START Center for Cancer Care.
San Antonio, Texas, 78229
Florida Cancer Specialists
Sarasota, Florida, 34230
About this study
Official title: A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies
Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced malignancies.
- Conditions
- Advanced Cancer, Ovarian Cancer, Lung Cancer, Colon Cancer, Plasma Cell Neoplasm, Multiple Myeloma
- Being tested
- Dose escalation: COM902 monotherapy., Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE), Cohort expansion: COM902 (RDFE) monotherapy., Cohort expansion: COM902 in combination with COM701 (both at the RDFE)., Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
- Keywords
- TIGIT antibody, PVRIG antibody, COM701, Low Fc-effector function, Pembrolizumab
- Medical subject headings
- Ovarian Neoplasms, Lung Neoplasms, Colonic Neoplasms, Neoplasms, Plasma Cell, Multiple Myeloma, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalation: COM902 monotherapy.Drug
COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)Combination product
Both study drugs will be evaluated at the RDFE for assessment of safety and tolerability. All study drugs will be administered IV every 3 weeks.
Cohort expansion: COM902 (RDFE) monotherapy.Drug
COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
Cohort expansion: COM902 in combination with COM701 (both at the RDFE).Drug
COM902 in combination with COM701 (both at RDFE) in subjects with select tumor types who have exhausted standard treatment - HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.
Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.Combination product
Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| COM902 monotherapy dose escalation. | Experimental | Monotherapy dose escalation. COM902 monotherapy administered IV every 3 weeks in sequential dose escalation. Up to 7 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended dose for expansion (RDFE) is identified. Receives: Drug: Dose escalation: COM902 monotherapy. |
| Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE). | Experimental | COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks. Receives: Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) |
| COM902 monotherapy cohort expansion at RDFE. | Experimental | COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks. Receives: Drug: Cohort expansion: COM902 (RDFE) monotherapy. |
| COM902 + COM701 combination cohort expansion both at RDFE. | Experimental | COM902 + COM701 (both at the RDFE) evaluated in subjects with select tumor types who have exhausted standard of care treatment: HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks. Receives: Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE). |
| MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab). | Experimental | Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks. Receives: Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab. |
| Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab). | Experimental | Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks. Receives: Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of COM902 monotherapy and in combination with COM701.
Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).
Measured: DLT evaluation window in the 1st cycle (21 Days).
To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701.
Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.
Measured: 18 months.
To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701.
Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration [Cmax]).
Measured: 18 months.
Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.
Measured: 18 months.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of PK parameters e.g., Cmax.
Measured: 18 months.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of PK parameters e.g., AUC.
Measured: 18 months.
Secondary outcomes (2)
To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.
Measured: 18 months.
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of antidrug antibody to COM902, COM701.
Measured: 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start31 Mar 2020
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Compugen Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- COM902 Study Director COM902 Study Director, Study director, Compugen Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354246
- Sponsor's protocol ID
- CPG-02-101
- Status last verified
- May 2026
- First submitted
- 15 Apr 2020
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT04354246
- Acronym / sponsor ID
- CPG-02-101
- Conditions
- Advanced Cancer, Ovarian Cancer, Lung Cancer, Colon Cancer, Plasma Cell Neoplasm, Multiple Myeloma
- Keywords
- TIGIT antibody, PVRIG antibody, COM701, Low Fc-effector function, Pembrolizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Compugen LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 21 Apr 2020 (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.
Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| COM902 monotherapy dose escalation. | Experimental | Drug: Dose escalation: COM902 monotherapy.Monotherapy dose escalation. COM902 monotherapy administered IV every 3 weeks in sequential dose escalation. Up to 7 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended dose for expansion (RDFE) is identified. |
| Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE). | Experimental | Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks. |
| COM902 monotherapy cohort expansion at RDFE. | Experimental | Drug: Cohort expansion: COM902 (RDFE) monotherapy.COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks. |
| COM902 + COM701 combination cohort expansion both at RDFE. | Experimental | Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE).COM902 + COM701 (both at the RDFE) evaluated in subjects with select tumor types who have exhausted standard of care treatment: HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks. |
| MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab). | Experimental | Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks. |
| Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab). | Experimental | Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects with histologically/cytologically confirmed advanced malignancy (solid tumor) who must have exhausted all available standard therapy, or not a candidate for standard therapy.
- Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Histologically confirmed adenocarcinoma of the colon/rectum
- Stage IV disease
Key exclusion criteria (5 listed)
- Prior treatment with a TIGIT inhibitor.
- Prior treatment with an inhibitor of PVRIG
- Symptomatic interstitial lung disease or inflammatory pneumonitis.
- History of immune-related events that required immunotherapy treatment discontinuation
- For Triplet combination expansion cohorts (MSS-CRC and PROC): Prior treatment with an anti-PD-1/PD-L1/2, anti-CD96 antibody, anti-OX-40 antibody, anti-CD137 antibody, anti-LAG3, anti-TIM3, anti-CTLA4 antibody.
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 |
|---|---|---|
| Dose escalation: COM902 monotherapy.COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects. | Drug | COM902 monotherapy dose escalation. |
| Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)Both study drugs will be evaluated at the RDFE for assessment of safety and tolerability. All study drugs will be administered IV every 3 weeks. | Combination product | Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE). |
| Cohort expansion: COM902 (RDFE) monotherapy.COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks. | Drug | COM902 monotherapy cohort expansion at RDFE. |
| Cohort expansion: COM902 in combination with COM701 (both at the RDFE).COM902 in combination with COM701 (both at RDFE) in subjects with select tumor types who have exhausted standard treatment - HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks. | Drug | COM902 + COM701 combination cohort expansion both at RDFE. |
| Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks. | Combination product | MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab)., Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab). |
Primary outcome
The safety and tolerability of COM902 monotherapy and in combination with COM701.
Time frame: DLT evaluation window in the 1st cycle (21 Days).
Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).
To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701.
Time frame: 18 months.
Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.
To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701.
Time frame: 18 months.
Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration [Cmax]).
Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Time frame: 18 months.
Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Time frame: 18 months.
Evaluation of PK parameters e.g., Cmax.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Time frame: 18 months.
Evaluation of PK parameters e.g., AUC.
2 secondary outcomes
To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
Time frame: 18 months.
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Time frame: 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
COM902 Study Director COM902 Study Director study director
Compugen Ltd
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose escalation: COM902 monotherapy., Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) and Cohort expansion: COM902 (RDFE) monotherapy. in people with Advanced Cancer and Ovarian Cancer, run by Compugen Ltd at 9 sites in United States.
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 13 inclusion and 5 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: finished, 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 9 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The safety and tolerability of COM902 monotherapy and in combination with COM701. (time frame: DLT evaluation window in the 1st cycle (21 Days).). The study lists 6 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.