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Protocol # 20-208

Status

Recruiting

Description

A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with pembrolizumab in HER2 expressing or amplified advanced malignancies

Condition

  • HER2 Positive Solid Tumors

Interventions

  • SBT6050
  • pembrolizumab

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • The proportion of subjects experiencing dose limiting toxicities
  • The incidence and severity of adverse events (AEs) and serious adverse events
  • Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)
  • Duration of response, defined as the time from date of first response (CR or PR)

Secondary Outcome:

  • Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)
  • Duration of response, defined as the time from date of first response (CR or PR)
  • Disease control rate, defined as CR, PR, or stable disease for at least 6 months
  • Estimates of selected pharmacokinetics (PK ) parameters for SBT6050
  • Estimates of selected pharmacokinetics (PK ) parameters for SBT6050
  • Incidence of antidrug antibodies (ADA) to SBT6050
  • Progression free survival

Enrollment

294

Study Start Date

July 27, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Silverback Therapeutics

Source

Silverback Therapeutics

Official title

A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Expressing HER2

Clinicaltrials.gov Identifier

NCT04460456

     

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.