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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose escalation: COM902 monotherapy. | Drug | COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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]). | 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. | 18 months. |
| Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab). | Evaluation of PK parameters e.g., Cmax. | 18 months. |
| Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab). | Evaluation of PK parameters e.g., AUC. | 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months. |
| To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months. |
| Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab). |
Key Inclusion Criteria:
For Triplet combination MSS-CRC:
For Triplet combination ovarian cancer:
Key Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| COM902 Study Director COM902 Study Director | Compugen Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists | Sarasota | Florida | 34230 | United States | ||
| Massachusetts General Hospital. |
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| Experimental |
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 | Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks. |
|
| 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. |
|
Evaluation of antidrug antibody to COM902, COM701. |
| 18 months. |
Assessment of preliminary antitumor activity e.g., ORR. |
| 24 months |
| 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 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D008175 | Lung Neoplasms |
| D003110 | Colonic Neoplasms |
| D054219 | Neoplasms, Plasma Cell |
| D009101 | Multiple Myeloma |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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