Clinical Trial 24236

• Overview

  Study Title:

  A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients with Advanced Solid Tumors

  Summary:

  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.

  Objective:

  Primary objectives: Part 1 (ERAS-0015 Monotherapy) - To identify the MTD and /or RDE(s) of ERAS-0015 monotherapy in adult participants with advanced solid tumors with RAS-MAPK alterations - To evaluate the safety and tolerability of ERAS-0015 monotherapy in adult participants with advanced solid tumors with RAS-MAPK alterations - To characterize the single dose and repeat dose PK profile of ERAS-0015 monotherapy in participants with advanced solid tumors with RAS-MAPK alterations Parts 2 and 3 (Combination Therapy) - To identify the MTD and/or RDE of ERAS-0015 in combination with the study drug(s) of interest in adult participants with advanced solid tumors with RAS-MAPK alterations - To evaluate the safety and tolerability of ERAS-0015 in combination with the study drug(s) of interest in adult participants with advanced solid tumors with RAS-MAPK alterations Secondary objectives: Part 1 (ERAS-0015 Monotherapy) - To evaluate the preliminary antitumor activity of ERAS-0015 monotherapy in adult participants with advanced solid tumors with RAS-MAPK alterations Secondary Parts 2 and 3 (Combination Therapy) - To characterize the single dose and repeat dose PK profile of ERAS-0015 in combination with study drug(s) of interest in adult participants with advanced solid tumors with RAS-MAPK alterations - To assess the potential DDI effect of ERAS-0015 on paclitaxel PK in participants enrolled in dose escalation of Parts 3B and 3C - To assess the potential DDI effect of ERAS-0015 on docetaxel PK in participants enrolled in dose escalation of Part 3E - To evaluate the preliminary antitumor activity of ERAS-0015 in combination with study drug(s) of interest in adult participants with advanced solid tumors with RAS-MAPK alterations

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy; RAS inhibitor

  Medications:

  5-fluorouracil (); Alimta (Pemetrexed); ERAS-0015 (); Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); Oxaliplatin (); Panitumumab (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); Taxotere (docetaxel); Vectibix (Panitumumab); carboplatin (); cisplatin (); docetaxel (); eloxatin (Oxaliplatin); gemcitabine (); leucovorin ()

• Inclusion Criteria

  Inclusion Criteria:
  • 18 years of age or older
  • Willing and able to give written informed consent
  • Pathological documentation of tumor type and mutation prior to the first dose of study drug(s), for applicable cohorts.
  • 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
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Previous treatment with a RAS inhibitor
  • 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-0015
  • Received prior palliative radiation within 14 days of Cycle 1, Day 1
  • Have primary central nervous system (CNS) tumors
  • 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
  • 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.
  • Other exclusions may apply

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.