Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, and other locations
Dates
study started
completion around

Description

Summary

This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-116, in Patients with Advanced Solid Tumors

Official Title

First-in-Human, Phase 1 Study of AMT-116 in Patients With Advanced Solid Tumors

Keywords

Advanced Solid Tumor, Neoplasms, AMT-116

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 head and neck, non-small cell lung, esophageal, pancreatic, large cell lung, colorectal, 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.
  • Patients must have at least one measurable lesion as per RECIST version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Both male and female patients must agree to use effective contraceptive methods.
  • Patients must have adequate organ function.
  • Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
  • Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.
  • Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.
  • Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.

You CAN'T join if...

  • 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.
  • Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.
  • Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
  • Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
  • Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days.
  • Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the IMP, or no recovery from side effects of such intervention.
  • Prior allogeneic or autologous bone marrow transplantation.
  • Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias.
  • Pregnant or breast-feeding females.

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Locations

  • UCSF Cancer Center not yet accepting patients
    San Francisco 94115 American Samoa
  • Sarah Cannon Research Institute not yet accepting patients
    Denver Colorado 80218 United States
  • Mary Crowley Cancer Research Centers accepting new patients
    Dallas Texas 75230 United States
  • Carolina BioOncology Institute, LLC accepting new patients
    Cary 28078 American Samoa

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Multitude Therapeutics Inc.
ID
NCT05725291
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated