a phase i study of rgt-264 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a phase 1 dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of rgt-264 as monotherapy in subjects with advanced solid tumors.

this first-in-human (fih) study of rgt-264 will evaluate safety, pharmacokinetics (pk) and efficacy of rgt-264 in subjects with advanced solid tumors. the primary objective is to determine the maximum tolerated dose (mtd)/maximum administered dose (mad) and the recommended phase ii dose (rp2d) of rgt-264 as monotherapy, and to evaluate the safety and tolerability of rgt-264. the secondary objectives include the assessments of pk profile and preliminary efficacy of rgt-264.

Eligibility criteria:
inclusion criteria: * able to sign the icf and agree to comply with the requirements of the study; * subjects with pathologically confirmed advanced solid tumors who have failed standard-of-care therapy, or have no standard-of-care therapy available, or are currently not eligible for standard-of-care therapy; * ecog performance status score of 0 to 1; * expected survival ≥ 3 months; * with at least one measurable lesion per recist v1.1; * subjects should discontinue all anti-tumor therapies prior to receiving study treatment, and the toxicity caused by prior anti-tumor therapy has recovered to ≤ grade 1 per ctcae v5.0; * the specific requirements of washout period should be met before first dose; * adequate organ function * female subjects of childbearing potential must have a negative pregnancy test prior to the first dose and are required to use effective contraception from signing the icf until 6 months after the last dose of study treatment exclusion criteria: * presence of risks that may significantly affect the absorption of the investigational product (e.g. inability to swallow, intestinal obstruction, chronic diarrhea, etc.); * having received immunotherapy and experienced ≥ grade 3 immune-related adverse events (iraes) or ≥ grade 2 immune-related myocarditis; * having received systemic glucocorticoids (\> 10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days prior to the first dose of investigational product; * presence of symptomatic parenchymal brain metastasis or leptomeningeal metastasis; * active, or previous autoimmune disease with the potential for relapse (excluding well-controlled type 1 diabetes mellitus; manageable hypothyroidism with hormone replacement therapy only).; * any other malignancy (except cured basal cell carcinoma of skin and in-situ carcinoma of the cervix) within 3 years prior to the first dose; * history of serious cardiovascular and cerebrovascular diseases; * presence of active interstitial lung disease or history of interstitial lung disease requiring glucocorticoid treatment; * presence of severe chronic or active infections (including tuberculosis infection, etc.) requiring intravenous antimicrobial, antifungal or antiviral therapy; * active hbv or hcv infection; * history of immunodeficiency or organ transplantation; * presence of uncontrolled third spacing fluid; * concomitant diseases or any other conditions that may seriously jeopardize the subject's safety or affect the subject's completion of the study, at the discretion of the investigator.

Keywords: hematopoietic progenitor kinase 1 (hpk1) dose escalation dose expansion rgt-264 first-in-human