AMT-253 in Patients With Advanced Solid Tumours

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - 5.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • - 6.
Life expectancy ≥ 3 months.
  • - 7.
Patients must have adequate organ function.
  • - 8.
Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least twelve weeks after the last dose of the IMP.
  • - 9.
WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.
  • - 10.
Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least twelve weeks after the last dose of the IMP.
  • - 11.
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.
  • - 12.
Availability of tumor tissue sample at screening.

Exclusion Criteria:

  • - 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.
  • - 5.
Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
  • - 6.
Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
  • - 7.
Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.
  • - 8.
Significant cardiac disease, such as recent myocardial infarction or acute coronary syndromes, congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias.
  • - 9.
History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.
  • - 10.
Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
  • - 11.
Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06209580
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Multitude Therapeutics Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Melanoma, Advanced Solid Tumors
Arms & Interventions

Arms

Experimental: Arm 1

AMT-253 Dose Escalation

Experimental: Arm 2

AMT-253 Dose Expansion

Interventions

Drug: - AMT-253 for injection

Administered intravenously

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Cancer Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Cancer Hospital

Beijing, Beijing,

Site Contact

Jun Guo

[email protected]

86-010-88121122

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