A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors

Conditions

• HER2 Positive Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SBT6050 — DRUG
  Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
• pembrolizumab — DRUG
  400 mg IV
• Cemiplimab — DRUG
  350 mg IV

Study Details

A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies

Key Dates

Start date

Jul 27, 2020

Status verified

Jun 2022

Primary completion

Dec 31, 2022

Completion

Dec 31, 2022

Study Design

Enrollment

58 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: SBT6050 Monotherapy
  Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.
• Experimental: SBT6050 and pembrolizumab
  Escalating doses of SBT6050 in combination with pembrolizumab in Part 3 followed by expansion in Part 4 at the recommended dose determined in Part 3.
• Experimental: SBT6050 and cemiplimab
  SBT6050 in combination with cemiplimab in Part 5 at the recommended dose determined in Parts 1 and 3.

Primary Outcome Measure

The proportion of subjects experiencing dose limiting toxicities [ Time Frame: 28 days ]

Locations (6)

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