Testing ERAS-0015 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of ERAS-0015 in patients with advanced or metastatic solid tumors that have specific RAS mutations. It is a first-in-human, Phase 1/1b, open-label, multicenter study that begins with dose optimization of ERAS-0015 as a standalone treatment, followed by its use in combination with other cancer therapies. The study aims to determine the optimal dosing and assess the drug's effectiveness in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* 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. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort.
* 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 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

Where it's running

• Providence Medical Group
  Santa Rosa, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting
• Florida Cancer Specalists
  Sarasota, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Massachusetts General Hospital (MG)
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Erasca Clinical Team Team
• Email: clinicaltrials@erasca.com
• Phone: +1-858-465-6511

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SLR-108 PET Imaging for Metastatic Solid Tumors

  A Phase 1 study to see if SLR-108 can be safely used for PET imaging of metastatic solid tumors in adults.

  Recruiting Phase 1 Solve Therapeutics · Newport Beach, California · NCT07728942

• TROP2-targeted CAR-NK cell therapy for advanced solid tumors

  This study tests EB-NK-301, an off-the-shelf CAR-NK cell therapy, in adults with advanced or metastatic TROP2-expressing solid tumors after standard treatments have failed.

  Recruiting Phase 1/2 Beijing Biotech · Shenzhen, Guangdong · NCT07589530

• Combining RAS(ON) inhibitors with ivonescimab for adults with RAS‑mutant advanced solid tumors

  This trial will test whether combining RAS(ON) inhibitors with ivonescimab is safe and can shrink or control tumors in adults with advanced or metastatic solid tumors that have RAS mutations.

  Recruiting at 19 sites Phase 1/2 Revolution Medicines, Inc. · Scottsdale, Arizona and 18 other locations · NCT07397338

• ADCX-020 treatment for advanced or metastatic solid tumors

  This trial will test ADCX-020, an antibody–drug conjugate, in adults with advanced or metastatic solid tumors who have run out of standard treatment options.

  Recruiting at 9 sites Phase 1 Adcytherix SAS · Sydney, New South Wales and 8 other locations · NCT07238075

• Sarah Nanotechnology System treatment using magnetic hyperthermia for advanced metastatic solid tumors

  This trial will try a single IV dose of iron-oxide nanoparticles followed by a low-frequency magnetic field to heat tumors in people with stage 4 metastatic solid tumors who have exhausted standard treatments.

  Recruiting New Phase Ltd. · Rochester, Minnesota · NCT07224464

• CKD-512 alone and with pembrolizumab for advanced or metastatic solid tumors

  This study will try CKD-512 by itself and together with pembrolizumab in people with advanced or metastatic solid tumors who have exhausted standard treatments.

  Recruiting Phase 1 Chong Kun Dang Pharmaceutical · Seoul · NCT07215637

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.