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A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

NCT04866134 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-08-27

No results posted yet for this study

Summary

* To evaluate the safety and tolerability of ERAS-007 monotherapy administered once weekly (QW) and twice daily-once weekly (BID-QW).
* To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 monotherapy administered BID-QW.
* To characterize the pharmacokinetic (PK) profile of ERAS-007 monotherapy.
* To determine the optimal dose and schedule of ERAS-007 monotherapy.
* To evaluate antitumor activity of ERAS-007 in various solid tumors.
* To evaluate the safety and tolerability of ERAS-007 (BID-QW) and ERAS-601 (twice daily for three weeks on and 1 week off (BID 3/1)) when administered in combination.
* To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with ERAS-601.
* To characterize the pharmacokinetic (PK) profile of ERAS-007 and ERAS-601 when administered in combination.
* To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors
* To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors

Conditions

  • Advanced or Metastatic Solid Tumors

Interventions

DRUG

ERAS-007

ERAS-007 will be administered orally as specified in Arm description.

DRUG

ERAS-601

ERAS-601 will be administered orally as specified in Arm description.

Sponsors & Collaborators

  • Erasca, Inc.

    lead INDUSTRY

Principal Investigators

  • Wei Lin, M.D. · Chief Medical Officer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2025-05-01
Completion
2025-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04866134 on ClinicalTrials.gov