Health TrialsbyHealthPanel

AMT-253 in Patients With Advanced Solid Tumours

ConditionsMalignant MelanomaAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMultitude Therapeutics Inc.

About this trial

This is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Patients must be willing and able to understand and sign the ICF, and to adhere to the study visit schedule and other protocol requirements.

2. Patients with histologically confirmed melanoma or other advanced solid tumor.

3. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.

4. Patients must have at least one measurable lesion as per RECIST version 1.1.

Disqualifiers

1. Prior treatment with any agent that has the same target.

2. Central nervous system (CNS) metastasis.

3. Active or chronic skin disorder requiring systemic therapy.

4. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.

Trial design

Design model

Single group

Treatments tested in this trial

  • AMT-253 for injection

    Drug

    Administered intravenously

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLTs

Incidence of dose limiting toxicities

Time frame
21 days after first dose
2

AEs

Type, incidence and severity of Adverse Events

Time frame
Up to 24 months
3

SAEs

Type, incidence and severity Serious Adverse Events (SAEs)

Time frame
Up to 24 months
4

ORR

Overall response rate assessed by the investigator according to RECIST version 1.1

Time frame
Up to 24 months

Secondary outcomes

1

Cmax

aximum concentration (Cmax)

Time frame
Up to 24 months
2

Tmax

time to peak drug concentration

Time frame
Up to 24 months
3

AUC

Area Under the Curve

Time frame
Up to 24 months
4

t1/2

terminal half-life of the ADC, total antibody and free payload

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

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

Multitude Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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