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TIGIT Inhibitor

COM902 for Cancer

Phase 1

Recruiting

Research Sponsored by Compugen Ltd

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

Must not have

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

Prior treatment with an inhibitor of PVRIG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with specific immune-targeting medications.

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I have been treated with a PVRIG inhibitor before.

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I have been treated with a TIGIT inhibitor before.

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I have lung inflammation or disease causing symptoms.

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I stopped immunotherapy due to an immune-related side effect.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

To characterize immunogenicity of COM902 monotherapy and in combination with COM701.

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

Other study objectives

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).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 14Eligibility criteria met