Health TrialsbyHealthPanel

Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors

ConditionEpithelial Tumors, Malignant
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMyeloid Therapeutics

About this trial

MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults age ≥ 18 inclusive at the time the Informed Consent Form (ICF) is signed.

Urothelial

Cervical

Ovarian epithelial

Disqualifiers

Known active CNS metastasis and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression for at least 4 weeks by repeat imaging), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study intervention.

Pregnant or nursing women.

Must be > 28 days beyond major surgery, including hepatectomy or joint replacement.

Prior allogeneic bone marrow transplantation or solid organ transplant.

Trial design

Design model

Single group

Treatments tested in this trial

  • MT-302 (A)

    Drug

    MT-302 is an investigational drug

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: A (MT-302)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the safety and tolerability of MT-302 through incidence of Adverse Events

Adverse Events will be graded according to the NCI-CTCAE, version 5.0

Time frame
Up to Week 20
2

To establish the maximum tolerated dose (MTD)

based on dose limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D)

Time frame
Up to Week 20

Secondary outcomes

1

To further characterize the safety of MT-302 through incidence of Adverse Events

Adverse Events will be graded according to the NCI-CTCAE, version 5.0

Time frame
Up to Week 20
2

To assess the pharmacokinetics (PK) of MT-302

PK parameter: Plasma concentrations

Time frame
Up to Week 20
3

To assess the pharmacokinetics (PK) of MT-302

PK parameter: Area under curve (AUC0-last, AUC 0-∞)

Time frame
Up to Week 20
4

To assess the pharmacokinetics (PK) of MT-302

PK parameter: Time of maximum observed plasma concentration (tmax)

Time frame
Up to Week 20

Other outcomes

Sponsors and contacts

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

Myeloid Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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