A Phase I, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AT03-65 in Adults with Advanced Solid Tumors
At least 18 years old at the time of signing written informed consent form (ICF).
Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1 at screening and on C1D1.
Pathologically documented, definitively diagnosed, advanced/metastatic solid tumor that is resistant or refractory to standard treatment, for which no further standard treatment is available, or the subject refuses or cannot tolerate standard therapy. Subjects must have measurable lesion according to response evaluation criteria in solid tumors (RECIST) v1.1.
Subjects (with documented CLDN6 expression after the lower three dose levels) will be enrolled, including but not limited to the following histological subtypes: serous or endometrioid ovarian cancer, primary peritoneal cancer or fallopian tube cancer, endometrial cancer, NSCLC, breast cancer, esophageal cancer, and gastric/GEJ cancer. There is no upper limit on the number of prior treatment regimens the subject may have received.
Subjects previously received or is currently receiving any systemic anti-cancer therapy within 4 weeks or 5xT(1/2) if 5xT(1/2) of the drug/therapy used by the subject is confirmed to be < 4 weeks, 5xT(1/2) shall prevail] - prior to first dose of IMP
Not yet recovered to Grade 1 or baseline for treatment-related toxicities related to previous treatment with the exception of alopecia. The recovery time after surgery was less than 28 days
Subjects with clinically significant congenital or acquired cardiovascular diseases.
Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening, except appropriately treated BCC of the skin or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment
Sequential
AT03-65
DrugTreatment will continue until disease progression, unacceptable toxicity, subject withdrawal of consent or death.
Maximum tolerated dose (MTD) of AT03-65
The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.
Dose-limiting toxicity (DLT)
DLT refers to AEs that occurred during DLT observation period in dose escalation study, excluding toxicities clearly due to the underlying disease or extraneous causes.
Determine levels of AT03-65 and its constituents over time in plasma
Assess PK concentration of AT03-65 in peripheral blood
Evaluate changes in circulating tumor DNA in plasma
Assess PD markers related to AT03-65 in peripheral blood
Determine the presence of antibodies to AT03-65 at different times in plasma
Assess immunogenicity concentration in peripheral blood
Assessment of Overall Response Rate (ORR) in subjects with advanced / metastatic solid tumors
Percentage of subjects whose best response is observed to be CR or PR throughout the study as assessed by local radiological assessment made by investigator according to RECIST V1.1
Click on the lead sponsor to view all of their trials.
