An Early Phase Clinical Trial to Evaluate COM701 in Relapsed Platinum Sensitive Ovarian Cancer (PSOC)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Compugen Ltd., Compugen Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

5 Sep 2025 → ongoing

Decision date (initial)

2025-07-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Compugen Ltd.

External identifiers

EU CT number

2025-521125-33-00

ClinicalTrials.gov

NCT06888921

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the effect of COM701 as a single agent on Progression Free Survival when administered as a maintenance regimen in participants with relapsed PSOC.

Secondary objectives 2

1. To evaluate the safety and tolerability of the COM701 as a single agent when administered as a maintenance regimen in participants with relapsed PSOC
2. To evaluate the effect of COM701 as a single agent on other efficacy endpoints when administered as a maintenance regimen in participants with relapsed PSOC

Conditions and MedDRA coding

Ovarian Cancer

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
2. Has completed at least 2 previous courses (i.e. lines) of platinum-containing therapy
3. Has received prior maintenance therapy with bevacizumab or a PARP inhibitor if eligible.
4. 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.

Exclusion criteria 16

1. Have any of the following histologies: clear cell carcinoma, low-grade serous carcinoma, malignant sex cord stromal tumors, malignant germ cell tumors, pure sarcoma
2. Received a live viral vaccine within 30 days of planned start of study treatment or requiring a live vaccine during the study.
3. Females who are pregnant or breastfeeding or planning to become pregnant during the period of the study.
4. History of severe allergic, anaphylactic, or other hypersensitivity reactions to a humanor humanized monoclonal antibody (mAb) or allergy to any excipients in theinvestigational products.
5. Are currently participating in or have participated in a clinical study and received an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment.
6. Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinionof the investigator, would make the subject inappropriate for entry into the study.
7. Participants residing in France deprived of their liberty by a judicial or administrative decision, and/or persons under psychiatric care within the meaning of Article L1121-6of the Public Health Code.
8. Have 4 or more (inclusive of 4) lines of cytotoxic chemotherapy in total.
9. Have a known additional malignancy that progressed or required active treatment within the last 5 years.
10. Presence of radiographic or biopsy proven liver metastases at the beginning or completion of current line of platinum-based chemotherapy.
11. Therapy with immunosuppressive doses of systemic medications, such as steroids (doses > 10 mg/day prednisone or equivalent daily) within 2 weeks before study drug administration.
12. Prior PD-1, PD-L1, anti-PVRIG, TIGIT or any other check point inhibitors
13. Have AEs from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except alopecia of any grade and Grade 2 neuropathy.
14. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or participants with human immunodeficiency virus (HIV).
15. Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
16. Has had an allogeneic tissue/solid organ transplant.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression free survival per investigator assessed RECIST 1.1 in COM701-treated participants compared to placebo-treated participants

Secondary endpoints 3

1. Frequency of AEs and SAEs and severity per CTCAE 5.0 in COM701-treated participants compared to placebo-treated participants
2. Changes from baseline in safety laboratory parameters, vital signs and ECG in COM701-treated participants compared to placebo-treated participants.
3. Time to the initiation of a new anti-cancer treatment in COM701-treated participants compared to placebo-treated participants

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Compugen Ltd.

Sponsor organisation

Compugen Ltd.

Address

Azriella Centre, 26 Ha-Rokmim 26 Ha-Rokmim

City

Holon

Postcode

5885849

Country

Israel

Scientific contact point

Organisation

Compugen Ltd.

Contact name

Michelle

Public contact point

Organisation

Compugen Ltd.

Contact name

Michelle

Third parties 6

Compugen Ltd.

Sponsor organisation

Compugen Ltd.

Address

Azrieli Centre, 26 Ha-Rokmim 26 Ha-Rokmim

City

Holon

Postcode

5885849

Country

Israel

Sponsor responsibilities

Article 77 compliance

Compugen Ltd.

Contact point sponsor

Compugen Ltd.

Article 77 implementation

Compugen Ltd.

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications