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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

ConditionsNSCLC (Non-small Cell Lung Cancer)HNSCCEndometrialOvarian CancerEsophageal CancerHead & Neck CancerGastric Cancer (GC)Endometrial Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTwoStep Therapeutics, Inc.

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males & females ≥18 years of age at the time of consent

Willingness to provide written informed consent, according to local guidelines.

Non-small cell lung cancer (NSCLC)

Head and neck squamous cell carcinoma (HNSCC)

Disqualifiers

Unresolved toxicity higher than Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v 6.0 (or higher) attributed to any prior therapy/procedure at Screening, except for alopecia, well-controlled Grade 2 hypothyroidism, or Grade 2 adrenal insufficiency that is actively managed with appropriate therapy

Subjects with ongoing sensory or motor neuropathy ≥Grade 2

Subjects with active or chronic keratitis or corneal disorders, including ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the Investigator.

Known sensitivity to any of the ingredients of TS-104 or MMAE

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

74 Participants
are divided into 3 treatment groups
Group A: Dose Escalation- 2Q3WExperimental treatment 1 intervention
Group B: Dose Escalation- Q2WExperimental treatment 1 intervention
Group C: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Adverse Events Following Administration of TS-104

To assess safety and tolerability. Safety reported as incidence of adverse events using CTCAE v6.0 criteria.

Time frame
From the first dose of TS-104 until 28 days after the last dose of TS-104 (up to 26 months)
2

Number of Participants with Dose Limiting Toxicities (DLTs) from TS-104

Number of participants who experience TS-104 dose limiting toxicities.

Time frame
Up to 21 days (for 2Q3W regimen) or Up to 28 days (for Q2W regimen) from the first dose

Secondary outcomes

1

Objective Response Rate (ORR)

Percentage of participants achieving a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST v1.1

Time frame
Every six weeks from the first dose of TS-104 for the first 8 cycles, and then every 8 weeks beginning with Cycle 10 until disease progression or death. (up to 26 months)
2

Duration of Response (DOR)

Time from first documented CR or PR to first documented disease progression or death from any cause, among subjects who achieve an objective response

Time frame
Every six weeks from the first dose for the first 8 cycles, and then every 8 weeks beginning with Cycle 10 until disease progression or death.
3

Progression-Free Survival (PFS)

Time from first dose of study drug to first documented disease progression or death from any cause, whichever occurs first

Time frame
Every six weeks from the first dose for the first 8 cycles, and then every 8 weeks beginning with Cycle 10 until disease progression or death.
4

Overall Survival (OS)

Time from first dose of study drug to death from any cause

Time frame
From first dose until death or study completion, assessed up to approximately 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TwoStep Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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