A Phase I Study of RGT-264 in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2025-08-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regor Pharmaceuticals Inc.

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.