ERAS-007 for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pancreatic Cancer+1 MoreERAS-007 - Drug
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it is safe and works well with other cancer treatments. They will also look at how the body processes the drug.

Eligible Conditions
  • Pancreatic Cancer
  • Metastatic Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: Assessed up to 24 months from time of first dose

Month 24
Adverse Events
Duration of Response (DOR)
Objective Response Rate (ORR)
Day 29
Area under the curve
Dose Limiting Toxicities (DLT)
Half-life
Maximum Tolerated Dose (MTD)
Plasma concentration (Cmax)
Recommended Dose (RD)
Time to achieve Cmax (Tmax)

Trial Safety

Safety Progress

1 of 3

Trial Design

8 Treatment Groups

Dose Escalation (Parts B1a, B2a, B3a or B4a): ERAS-007 in combination with palbo...
1 of 8
Dose Escalation (Parts A1a, A2a, or A3a): ERAS-007 in combination with encorafen...
1 of 8
Dose Escalation (Part 2): ERAS-007 in combination with palbociclib
1 of 8
Dose Expansion (Parts B1b, B2b, B3b, and B4b): ERAS-007 in combination with palb...
1 of 8
Dose Expan (Parts A1b, A1c, A2b, A2c, A3b, or A3c): ERAS-007 in combo with encor...
1 of 8
Dose Escalation (Part 1): ERAS-007 in combination with encorafenib and cetuximab
1 of 8
Dose Expansion (Part 3): ERAS-007 in combination with encorafenib and cetuximab
1 of 8
Dose Expansion (Part 4): ERAS-007 in combination with palbociclib
1 of 8

Experimental Treatment

200 Total Participants · 8 Treatment Groups

Primary Treatment: ERAS-007 · No Placebo Group · Phase 1 & 2

Dose Escalation (Parts B1a, B2a, B3a or B4a): ERAS-007 in combination with palbociclibExperimental Group · 2 Interventions: ERAS-007, Palbociclib · Intervention Types: Drug, Drug
Dose Escalation (Parts A1a, A2a, or A3a): ERAS-007 in combination with encorafenib and cetuximabExperimental Group · 3 Interventions: ERAS-007, Cetuximab, Encorafenib · Intervention Types: Drug, Drug, Drug
Dose Escalation (Part 2): ERAS-007 in combination with palbociclibExperimental Group · 2 Interventions: ERAS-007, Palbociclib · Intervention Types: Drug, Drug
Dose Expansion (Parts B1b, B2b, B3b, and B4b): ERAS-007 in combination with palbociclibExperimental Group · 2 Interventions: ERAS-007, Palbociclib · Intervention Types: Drug, Drug
Dose Expan (Parts A1b, A1c, A2b, A2c, A3b, or A3c): ERAS-007 in combo with encorafenib & cetuximabExperimental Group · 3 Interventions: ERAS-007, Cetuximab, Encorafenib · Intervention Types: Drug, Drug, Drug
Dose Escalation (Part 1): ERAS-007 in combination with encorafenib and cetuximabExperimental Group · 3 Interventions: ERAS-007, Cetuximab, Encorafenib · Intervention Types: Drug, Drug, Drug
Dose Expansion (Part 3): ERAS-007 in combination with encorafenib and cetuximabExperimental Group · 3 Interventions: ERAS-007, Cetuximab, Encorafenib · Intervention Types: Drug, Drug, Drug
Dose Expansion (Part 4): ERAS-007 in combination with palbociclibExperimental Group · 2 Interventions: ERAS-007, Palbociclib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved
Palbociclib
FDA approved
Encorafenib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed up to 24 months from time of first dose

Who is running the clinical trial?

Erasca, Inc.Lead Sponsor
5 Previous Clinical Trials
690 Total Patients Enrolled
Kimberly Komatsubara, M.D.Study DirectorSenior Medical Director
1 Previous Clinical Trials
200 Total Patients Enrolled
Wei Lin, M.D.Study DirectorChief Medical Officer
1 Previous Clinical Trials
200 Total Patients Enrolled

Eligibility Criteria

Age 18 - 99 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have metastatic colorectal cancer and you have a mutation in the BRAF or KRAS gene or a mutation in the NRAS gene.
You have measurable disease per RECIST v1.1.
You have no symptoms or signs of cancer.\n
You are willing to comply with all protocol-required visits, assessments, and procedures.