A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.

Purpose

The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain KRAS mutations. ERAS-4001 will be given alone or in combination with other treatments.

Condition

  • Metastatic Solid Tumors

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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) - 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 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-4001 - 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ERAS-4001 Monotherapy Dose Optimization. 		Escalating doses of ERAS-4001 administered orally.
  • Drug: ERAS-4001
    ERAS-4001 Administered orally
Experimental
ERAS-4001 Combination Dose Optimization 		ERAS-4001 administered orally with another investigational agent.
  • Drug: ERAS-4001 in combination
    ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
    Other names:
    • Keytruda (pembrolizumab)
    • Vectibix (panitumumab)

Recruiting Locations

Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville 4644585, Tennessee 4662168 32703

The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

NEXT Oncology
Irving 4700168, Texas 4736286 75039

NEXT Oncology
San Antonio 4726206, Texas 4736286 78229

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109

More Details

Status
Recruiting
Sponsor
Erasca, Inc.

Study Contact

Erasca Clinical Team
+1-858-465-6511
clinicaltrials@erasca.com

Detailed Description

This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-4001 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-4001 monotherapy, followed by dose optimization of ERAS-4001 in combination with other cancer therapies.