NCT04460456 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy,Treatment | Breast,Female reproductive organs,Stomach and upper gastrointestinal tract,Urinary systemBladder,Breast,Ovary,Pancreas,Stomach

Trial Overview Read MoreRead more

This phase I trial is trying to understand how a new immunotherapy works, if it is safe and how well it is tolerated when it is given alone or in combination with another immunotherapy drug, in patients with HER2 cancers.
 

This trial is treating patients with HER2 positive cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

Silverback Therapeutics

Summary

SBT6050 Monotherapy : Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1. Drug: SBT6050 : Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2 This study has 4 parts. Part 1 will evaluate the safety, tolerability and activity of escalating doses of SBT6050 to estimate the maximum tolerated dose (MTD) and determine the dose recommended for Part 2. Part 2 of the study will further evaluate SBT6050 in select HER2 expressing or amplified advanced malignancies.Part 3 will evaluate the safety, tolerability and activity of escalating doses of SBT6050 in combination with pembrolizumab to estimate the MTD and determine the dose recommended for Part 2. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab in select HER2 expressing or amplified advanced malignancies

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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