74 Participants NeededMy employer runs this trial

TS-104 for Cancer

Recruiting at 2 trial locations
TC
Overseen ByTwoStep Clinical Trials
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: TwoStep 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?

A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects with Select Advanced Solid Tumors.

The main goals of this study are to:

* Find the recommended dose of TS-104 that can safely be given to participants

* Learn more about the side effects of TS-104

* Learn more about the effectiveness of TS-104

* Learn more about the pharmacokinetics of TS-104

Are You a Good Fit for This Trial?

This trial is for adults (18+) with certain advanced cancers, such as ovarian, endometrial, gastric, esophageal, non-small cell lung cancer, or head and neck cancers. Participants must have measurable disease and be willing to provide tumor samples and informed consent.

Inclusion Criteria

Willingness to provide written informed consent according to local guidelines
I have advanced or metastatic cancer that is not responding to or cannot be treated with standard therapy.
Subjects must have measurable disease based on RECIST version 1.1
See 6 more

Exclusion Criteria

I am currently receiving or will need cancer treatment during the study.
Currently pregnant or breastfeeding
I have moderate or severe nerve problems like numbness or weakness.
See 14 more

What Are the Treatments Tested in This Trial?

Interventions

  • TS-104

Trial Overview

The study tests TS-104, a new peptide drug conjugate given alone to people with select advanced solid tumors. The main goals are to find a safe dose and learn about its side effects and how it works in the body.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention
Group II: Dose Escalation- Q2WExperimental Treatment1 Intervention
Group III: Dose Escalation- 2Q3WExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

TwoStep Therapeutics, Inc.

Lead Sponsor