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

Sponsor
TwoStep Therapeutics, Inc.
Study ID
NCT07814248
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TS-104 — DRUG
    TS-104 is a peptide-drug conjugate that delivers the anticancer drug MMAE to tumors using a targeting peptide that binds to certain integrins commonly found on solid tumors.

Study Details

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

Key Dates

First listed
Sep 10, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
74 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation- 2Q3W
    TS-104 will be administered 2Q3W (i.e. on days 1 and 8 every 21 days)
  • Experimental: Dose Escalation- Q2W
    TS-104 will be administered Q2W (i.e. on days 1 and 15 every 28 days)
  • Experimental: Dose Expansion
    TS-104 will be administered either 2Q3W (i.e. on days 1 and 8 every 21 days) or Q2W (i.e. on days 1 and 15 every 28 days)

Primary Outcome Measure

Number of Participants with Adverse Events Following Administration of TS-104 [ Time Frame: From the first dose of TS-104 until 28 days after the last dose of TS-104 (up to 26 months) ]

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