Health TrialsbyHealthPanel

AMT-116 in Patients with Solid Tumors

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

About this trial

The purpose of this study is to evaluate the safety and efficacy of AMT-116 monotherapy in subjects with advanced solid tumors. The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Age ≥18 years (at the time consent is obtained).

Patients with histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include non-small cell lung, head and neck, esophageal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer.

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

Disqualifiers

Prior therapy with ADC based on Top1 inhibitor.

Central nervous system (CNS) metastasis.

Active or chronic skin disorder requiring systemic therapy.

History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.

Trial design

Design model

Sequential

Treatments tested in this trial

  • AMT-116

    Drug

    AMT-116 is an antibody Drug Conjugate (ADC)

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Phase I: Dose escalationExperimental treatment 1 intervention
Group B: Phase II: Dose ExpansionOther 1 intervention

Trial outcomes

Primary outcomes

1

Phase I: Maximum Tolerated Dose(MTD) and the Recommended Phase 2 Dose(RP2D) of AMT-116

The MTD（Maximum Tolerated Dose） and RP2D（Recommended Phase 2 Dose） will be determined for expansion using dose limiting toxicities (DLTs) and all other available study data

Time frame
approximately 12 months
2

Phase I: Type, incidence and severity of Adverse Events,Dose Limiting Toxicities (DLTs)

Assess safety and tolerability of AMT-116 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0

Time frame
approximately 12 months
3

Phase II: Objective Response Rate(ORR)

To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] according to the RECIST v1.1

Time frame
approximately 18 months
4

Phase II: Type, incidence and severity of Adverse Events

Assess safety and tolerability of AMT-116 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0

Time frame
approximately 18 months

Secondary outcomes

1

Phase I: Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Proportion of patients achieving Complete Response (CR) or Partial Response (PR)

Time frame
approximately 12 months
2

Phase I Disease Control Rate (DCR) according to the RECIST v1.1

Proportion of patients achieving CR, PR or Stable Disease (SD)

Time frame
approximately 12 months
3

Phase I: Progression-free Survival (PFS)

Time from date of start of treatment to date of the first progression or death, whichever occurs first

Time frame
approximately 12 months
4

Phase I: Levels of target expression or Tumor Infiltrating Lymphocyte in tumor tissue

To assess levels of target expression and Tumor Infiltrating Lymphocyte in tumor tissue

Time frame
approximately 12 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
Apply now