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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Subjects who have received PARP inhibitor therapy are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug, COM902, to see if it is safe and works well against cancer.
Who is the study for?
This trial is for adults with advanced cancers like ovarian, colon, or lung cancer who've tried standard treatments without success. They should be in relatively good physical condition (ECOG 0-1) and have had no more than three prior treatment lines. People with certain immune conditions or those previously treated with specific immunotherapies are not eligible.Check my eligibility
What is being tested?
The study tests COM902 alone and in combinations: as a monotherapy, paired with COM701, and alongside both COM701 and Pembrolizumab. It's to see how safe they are and if they can shrink tumors. The doses will increase until researchers find the highest dose patients can take without serious side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation of organs, skin issues, fatigue, possible infusion-related reactions similar to allergic responses, and an increased risk of infections due to immune suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ovarian cancer came back less than 6 months after platinum treatment.
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I have received PARP inhibitor therapy.
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My condition is at stage IV.
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I am fully active or can carry out light work.
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My cancer is a type of colon/rectum cancer confirmed by lab tests.
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I have an advanced cancer and have tried all standard treatments or can't receive them.
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My condition worsened after 3 or fewer treatments including specific chemotherapy drugs.
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My colorectal cancer is MSS as confirmed by an approved test.
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I have advanced cancer in my ovary, fallopian tube, or the lining of my abdomen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
The safety and tolerability of COM902 monotherapy and in combination with COM701.
+2 moreSecondary outcome measures
To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Other outcome measures
Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701.
Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab).
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
6Treatment groups
Experimental Treatment
Group I: Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).Experimental Treatment1 Intervention
Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks.
Group II: MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).Experimental Treatment1 Intervention
Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks.
Group III: Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).Experimental Treatment1 Intervention
COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.
Group IV: COM902 monotherapy dose escalation.Experimental Treatment1 Intervention
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.
Group V: COM902 monotherapy cohort expansion at RDFE.Experimental Treatment1 Intervention
COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
Group VI: COM902 + COM701 combination cohort expansion both at RDFE.Experimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Compugen LtdLead Sponsor
2 Previous Clinical Trials
240 Total Patients Enrolled
COM902 Study Director COM902 Study DirectorStudy DirectorCompugen Ltd
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with specific immune-targeting medications.I have received PARP inhibitor therapy.My condition is at stage IV.I am fully active or can carry out light work.I have been treated with a PVRIG inhibitor before.I have been treated with a TIGIT inhibitor before.My ovarian cancer came back less than 6 months after platinum treatment.My cancer is a type of colon/rectum cancer confirmed by lab tests.I have an advanced cancer and have tried all standard treatments or can't receive them.My condition worsened after 3 or fewer treatments including specific chemotherapy drugs.I have had 3 or fewer treatments for ovarian cancer, not counting maintenance drugs.I have lung inflammation or disease causing symptoms.My colorectal cancer is MSS as confirmed by an approved test.I stopped immunotherapy due to an immune-related side effect.I have advanced cancer in my ovary, fallopian tube, or the lining of my abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: COM902 + COM701 combination cohort expansion both at RDFE.
- Group 2: COM902 monotherapy dose escalation.
- Group 3: MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).
- Group 4: Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).
- Group 5: COM902 monotherapy cohort expansion at RDFE.
- Group 6: Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare institutions are overseeing this clinical trial?
"This research is currently enrolling participants from 6 sites, located in cities such as Dallas, Memphis and Grand Rapids. It's recommended to pick a site close to your residence; this way you can reduce the burden of travelling if accepted into the study."
Answered by AI
How reliable is the COM902 monotherapy dose increase procedure for human health?
"Our internal analysis gives Dose escalation: COM902 monotherapy. a score of one, due to the limited research that has been conducted on its safety and therapeutic potency."
Answered by AI
Are applications being accepted for this experimental research program?
"Per the clinicaltrials.gov website, enrollment for this medical trial is still active after its initial posting on March 31st of 2020 and subsequent update from August 8th 2022."
Answered by AI
What is the ceiling for enrollees in this clinical study?
"This trial necessitates 90 individuals that fit the specified criteria to join. Patients may go to Mary Crowley Cancer Research in Dallas, Tennessee or The University of Tennessee WEST Cancer Center in Memphis, Michigan for participation."
Answered by AI
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