Clinical trial NCT07021898: A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
Official title: A Phase 1 First-in-Human Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-4001 Monotherapy and in Combination in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Metastatic Solid Tumors
Keywords: Solid Tumor
Advanced Solid Tumor
Solid malignancies
Targeted therapy
Molecular alterations
pembrolizumab
Keytruda
panitumumab
Vectibix
Metastatic solid tumor
Neoplasms
Lead sponsor: Erasca, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dose Limiting Toxicities (DLT)
timeFrame: Study Day 1 up to Day 21
measure: Maximum tolerated dose (MTD)
timeFrame: Study Day 1 up to Day 21
measure: Recommended dose for expansion (RDE)
timeFrame: Study Day 1 up to Day 21
measure: Adverse Events
timeFrame: Study Day 1 up to Day 21
measure: Plasma concentration (Cmax)
timeFrame: Study Day 1 up to Day 65
measure: Time to achieve Cmax (Tmax)
timeFrame: Study Day 1 up to Day 65
measure: Area under the curve
timeFrame: Study Day 1 up to Day 65
measure: Half-life
timeFrame: Study Day 1 up to Day 65
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Assessed up to 24 months from time of first dose
measure: Duration of Response (DOR)
timeFrame: Assessed up to 24 months from time of first dose
measure: Time to Response (TTR)
timeFrame: Assessed up to 24 months from time of first dose
Other outcomes:
Locations:
Study officials:
References: