Health TrialsbyHealthPanel

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

ConditionMetastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorErasca, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • ERAS-4001

    Drug

    ERAS-4001 Administered orally

  • ERAS-4001 in combination

    Drug

    ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ERAS-4001 Monotherapy Dose Optimization.Experimental treatment 1 intervention
Group B: ERAS-4001 Combination Dose OptimizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicities (DLT)

Based on toxicities observed

Time frame
Study Day 1 up to Day 21
2

Maximum tolerated dose (MTD)

Based on toxicities observed

Time frame
Study Day 1 up to Day 21
3

Recommended dose for expansion (RDE)

Based on toxicities observed

Time frame
Study Day 1 up to Day 21
4

Adverse Events

Incidence and severity of treatment-emergent AEs and serious AEs

Time frame
Study Day 1 up to Day 21

Secondary outcomes

1

Objective Response Rate (ORR)

Based on assessment of radiographic imaging per RECIST version 1.1

Time frame
Assessed up to 24 months from time of first dose
2

Duration of Response (DOR)

Based on assessment of radiographic imaging per RECIST version 1.1

Time frame
Assessed up to 24 months from time of first dose
3

Time to Response (TTR)

Based on assessment of radiographic imaging per RECIST version 1.1

Time frame
Assessed up to 24 months from time of first dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasca, Inc.

Lead sponsor

Source ClinicalTrials.gov
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