An Open-Label, Multi-Center Phase 1/1b Dose Escalation and Expansion Study of ERAS-601 SHP2 Inhibitor as a Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced or Metastatic Solid Tumors

ERAS-601-01

* To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in study participants with advanced or metastatic solid tumors. * To determine the Maximum Tolerated Dose (MTD) and/or recommended dose (RD) of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies. * To characterize the pharmacokinetic (PK) profile of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies. * To evaluate the antitumor activity of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.

2020-12-15

2024-05-01

2024-05-01

Active (not recruiting)

Early phase I

200

Inclusion Criteria: * Age ≥ 18 years * Willing and able to give written informed consent * Have histologically or cytologically confirmed advanced or metastatic solid tumor * There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy * Able to swallow oral medication * Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 * Adequate cardiovascular, hematological, liver, and renal function * Willing to comply with all protocol-required visits, assessments, and procedures Exclusion Criteria: * Previous treatment with a SHP2 inhibitor * Documented PTPN11 mutations * Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-601 * Received prior palliative radiation within 7 days of Cycle 1, Day 1 * Have primary central nervous system (CNS) disease or known active CNS metastases and/or carcinomatous meningitis * Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption * Active, clinically significant interstitial lung disease or pneumonitis * History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to the first dose of study treatment * History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO * Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs * Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-11-28