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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-G59 | Other Identifier | Merck Sharp & Dohme LLC | |
| MK-3475-G59 | Other Identifier | Merck Sharp & Dohme LLC | |
| 2026-525794-39-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 will be given alone or in combination with other treatments.
This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-0015 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-0015 monotherapy, followed by dose optimization of ERAS-0015 in combination with other cancer therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS-0015 Monotherapy Dose Optimization. | Experimental | Escalating doses of ERAS-0015 administered orally. |
|
| ERAS-0015 Combination Dose Optimization | Experimental | ERAS-0015 administered orally with another investigational agent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS-0015 | Drug | ERAS-0015 Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities (DLT) | Based on toxicities observed | Study Day 1 up to Day 21 |
| Maximum tolerated dose (MTD) | Based on toxicities observed | Study Day 1 up to Day 21 |
| Recommended dose for expansion (RDE) | Based on toxicities observed | Study Day 1 up to Day 21 |
| Adverse Events | Incidence and severity of treatment-emergent AEs and serious AEs | Study Day 1 up to Day 21 |
| Plasma concentration (Cmax) | Maximum plasma concentration of ERAS-0015 | Study Day 1 up to 65 |
| Time to achieve Cmax (Tmax) | Time to achieve maximum plasma concentration of ERAS-0015 | Study Day 1 up to 65 |
| Area under the curve | Area under the plasma concentration-time curve of ERAS-0015 | Study Day 1 up to 65 |
| Half-life | Half-life of ERAS-0015 | Study Day 1 up to 65 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Based on assessment of radiographic imaging per RECIST version 1.1 | Assessed up to 24 months from time of first dose |
| Duration of Response (DOR) | Based on assessment of radiographic imaging per RECIST version 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erasca Clinical Team Team | Contact | +1-858-465-6511 | clinicaltrials@erasca.com | |
| Les Brail, Study Director, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Gerri Lee | Erasca, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specalists | Recruiting | Sarasota | Florida | 34232 | United States | |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000077544 | Panitumumab |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| ERAS-0015 in combination |
| Drug |
ERAS-0015 Administered orally and in combination with either KEYTRUDA® (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration. |
|
|
| Assessed up to 24 months from time of first dose |
| Time to Response (TTR) | Based on assessment of radiographic imaging per RECIST version 1.1 | Assessed up to 24 months from time of first dose |
| Moffitt Cancer Center |
| Recruiting |
| Tampa |
| Florida |
| 33612 |
| United States |
| Massachusetts General Hospital (MG) | Recruiting | Boston | Massachusetts | 02114 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| University of Texas at Tyler | Recruiting | Tyler | Texas | 75701 | United States |
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |