220 Participants NeededMy employer runs this trial

STX-003 + Pembrolizumab for Advanced Solid Tumors

Recruiting at 1 trial location
JL
Overseen ByJason Luke, MD, Chief Medical Officer
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Strand Therapeutics Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-003 Delivered by Intravenous Injection in Patients with Advanced Solid Tumors as a Monotherapy or in Combination with Pembrolizumab.

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, such as non-small cell lung cancer or melanoma, whose cancer has not responded to standard treatments. Participants should be in generally stable health and able to undergo regular clinic visits.

Inclusion Criteria

Body weight ≥ 40 kg
Coagulation: PT/INR or PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN unless on anticoagulation therapy
My kidney function is normal or only mildly reduced.
See 14 more

Exclusion Criteria

Known psychiatric or substance use disorder interfering with study cooperation
History of primary immune deficiency
I do not have severe immune side effects from treatment that are still unresolved.
See 23 more

What Are the Treatments Tested in This Trial?

Interventions

  • KEYTRUDA®
  • STX-003

Trial Overview

Researchers are testing a new drug called STX-003 given by IV, either alone or together with pembrolizumab (KEYTRUDA). The study aims to find the safest dose and see how well these treatments work against advanced cancers.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Phase 2 Monotherapy (STX-003)Experimental Treatment1 Intervention
Group II: Phase 2 Combination (STX-003 with Pembrolizumab)Experimental Treatment2 Interventions
Group III: Phase 1 MonotherapyExperimental Treatment1 Intervention
Group IV: Phase 1 Combination (STX-003 with Pembrolizumab)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Strand Therapeutics Inc.

Lead Sponsor

Trials
1
Recruited
110+