Brief Summary
This first-in-human study will evaluate the Maximum Tolerated Dosethe amount of medication taken (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-253, in Patients with Advancedat a late stage, far along Solid Tumors
Intervention / Treatment
- Drug: AMT-253
Inclusion Criteria
- 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 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 Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0-1.
- Life expectancy ≥ 3 months.
- Patients must have adequate organ function.
- 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 (i.e., who has had menses any time in the preceding 12 consecutive months) must agree to use two effective contraceptive methods (examples include oral, parenteral, or implantable hormonal contraceptive, intra-uterine device, barrier contraceptive with spermicide, partner’s latex condom or vasectomy) while on study treatment and for at least twelve weeks after the last dose of the IMP.
- WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.
- 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.
- 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 tumor tissuea group of cells that work together to perform a function sample (either an archival specimena sample for investigating (e.g. blood, stools, urine, sputum etc.) or a fresh biopsyremoval of a section of tissue to analyse for cancer cells material) at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.