ClinicalTrials.gg
CompletedNCT04354246Updated Aug 12, 2026

COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

A Phase 1 interventional study of Dose escalation: COM902 monotherapy. and Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) in Advanced Cancer, Ovarian Cancer and Lung Cancer, sponsored by Compugen Ltd. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Compugen Ltd · Phase 1, Interventional, and Treatment

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Phase
Phase 1
Study type
Interventional
Enrollment
94
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,778 studies in Ovarian Neoplasms with a site in United States — 280 open to participants now, 455 under way, 46 of them phase 3. Ovarian Neoplasms · United States.

Enrollment
470th of 1,497
94 · median 47
Started
2020
with 77 others
Phase 1
546 of 1,778
73 open now
Registered
1,273rd of 1,778
by date

Among the 1,778 studies in Ovarian Neoplasms with a site in United States, this one is the 470th largest by enrollment of the 1,497 interventional ones that give a count, is one of 78 that started in 2020, is one of 546 in phase 1, and was the 1,273rd registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

280 of the 1,778 studies in Ovarian Neoplasms with a site in United States are open now. Recruiting first, the newest first:

275 more — sign in →

All 280 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Advanced Cancer
  • Ovarian Cancer
  • Lung Cancer
  • Colon Cancer
  • Plasma Cell Neoplasm
  • Multiple Myeloma
  • HNSCC
  • Microsatellite Stable Colorectal Carcinoma
  • MSS-CRC

Keywords

  • TIGIT antibody
  • PVRIG antibody
  • COM701
  • Low Fc-effector function
  • Pembrolizumab
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Subjects with histologically/ confirmed advanced (solid tumor) who must have exhausted all available standard therapy, or not a candidate for standard therapy.
  • Subject is able to provide written, 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 (ECOG) performance status 0-1.

For Triplet combination MSS-CRC:

  • Histologically confirmed adenocarcinoma of the colon/rectum
  • Stage IV disease
  • MSS-CRC status by an FDA approved test
  • Disease progression with no more than 3 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 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

Key Exclusion Criteria:

  • 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 /PD-L1/2, anti-CD96 antibody, anti-OX-40 antibody, anti-CD137 antibody, anti-LAG3, anti-TIM3, anti-CTLA4 antibody.

Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
94 participants (actual)

Study arms

  • Experimental
    COM902 monotherapy dose escalation.

    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.

    Drug: Dose escalation: COM902 monotherapy.

  • Experimental
    Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).

    COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.

    Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)

  • Experimental
    COM902 monotherapy cohort expansion at RDFE.

    COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.

    Drug: Cohort expansion: COM902 (RDFE) monotherapy.

  • Experimental
    COM902 + COM701 combination cohort expansion both at 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.

    Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE).

  • Experimental
    MSS-CRC Triplet combination (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.

    Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.

  • Experimental
    Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).

    Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks.

    Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.

Interventions

  • DrugDose escalation: COM902 monotherapy.

    COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.

  • Combination productEvaluation 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.

  • DrugCohort expansion: COM902 (RDFE) monotherapy.

    COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.

  • DrugCohort 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.

  • Combination productCohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.

    Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.

This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: DLT evaluation window in the 1st cycle (21 Days).

  2. 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.

    Time frame: 18 months.

  3. 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 \[Cmax\]).

    Time frame: 18 months.

  4. 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.

    Time frame: 18 months.

  5. Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).

    Evaluation of PK parameters e.g., Cmax.

    Time frame: 18 months.

  6. Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).

    Evaluation of PK parameters e.g., AUC.

    Time frame: 18 months.

Secondary outcomes

  1. 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.

    Time frame: 18 months.

  2. To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).

    Evaluation of antidrug antibody to COM902, COM701.

    Time frame: 18 months.

Other outcomes

  1. Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701.

    An assessment of preliminary antitumor activity eg ORR with COM902 monotherapy and COM902 in combination with COM701.

    Time frame: 24 months.

  2. Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab).

    Assessment of preliminary antitumor activity e.g., ORR.

    Time frame: 24 months

07

Study locations

9 sites
  • Florida Cancer Specialists
    Sarasota, Florida 34230, United States
  • Massachusetts General Hospital.
    Boston, Massachusetts 02114, United States
  • START Midwest.
    Grand Rapids, Michigan 49503, United States
  • The Ohio State University Comprehensive Cancer Center.
    Columbus, Ohio 43210, United States
  • The University of Tennessee WEST Cancer Center.
    Memphis, Tennessee 38138, United States
  • Mary Crowley Cancer Research
    Dallas, Texas 75230, United States
  • MD Anderson Cancer Center.
    Houston, Texas 77030, United States
  • The START Center for Cancer Care.
    San Antonio, Texas 78229, United States
  • Froedtert & Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2020 to primary completion in Apr 2026, 72 months.

Of 210 industry-sponsored phase 1 interventional studies under Ovarian Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 65. This study's 72 months is above that.

Counting every sponsor, half of 380 studies reached it within 50 months; a quarter within 32 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2020
First posted
Apr 21, 2020
StartActual
Mar 31, 2020
Primary completionActual
Apr 1, 2026
CompletionActual
Apr 1, 2026
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04354246
Lead sponsor
Compugen Ltd
Responsible party
Sponsor
First posted
Apr 21, 2020
Start date
Mar 31, 2020
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026
Last update
Aug 12, 2026

Study contacts

COM902 Study Director COM902 Study Director
study director · Compugen Ltd

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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