← Back to all trials
Completed
NCT04670679
A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
Conditions: Advanced or Metastatic Solid Tumors
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 90
Sponsor: Erasca, Inc.
Location: University of Alabama at Birmingham Birmingham Alabama
Summary
* 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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04670679). StuddyBuddy aggregates publicly available trial information.