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Protocol # 22-129

Status

Recruiting

Description

- To evaluate the safety and tolerability of escalating doses of ERAS-007 in combination with other cancer therapies in study participants with advanced GI malignancies. - To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with other cancer therapies. - To evaluate the antitumor activity of ERAS-007 in combination with other cancer therapies. - To evaluate the PK profiles of ERAS-007 and other cancer therapies when administered in combination.

Condition

  • Metastatic Colorectal Cancer
  • Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

  • ERAS-007
  • Encorafenib
  • Cetuximab
  • Palbociclib

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Dose Limiting Toxicities (DLT)
  • Maximum Tolerated Dose (MTD)
  • Recommended Dose (RD)
  • Adverse Events

Secondary Outcome:

  • Plasma concentration (Cmax)
  • Time to achieve Cmax (Tmax)
  • Area under the curve
  • Half-life
  • Objective Response Rate (ORR)
  • Duration of Response (DOR)

Enrollment

200

Study Start Date

September 20, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     99 Years
  • Healthy volunteers:     No

Sponsors

Erasca, Inc.

Source

Erasca, Inc.

Official title

A Phase 1b/2 Study of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Advanced Gastrointestinal Malignancies (HERKULES-3)

Clinicaltrials.gov Identifier

NCT05039177

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.