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

NCT05764915 | Terminated Phase 1

• 2 other identifiers: RGT-264-101CTR20223017
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

Hematopoietic progenitor kinase 1 (HPK1); Dose Escalation; Dose Expansion; RGT-264; First-in-Human

Outcome Measures

Primary Outcomes (2)

• Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level in dose escalation stage

  DLTs will be evaluated from Day 1 (the day of the first dose) to Day 21 after first dose of study treatment in escalation stage. Number of DLTs will be used in dose ascending and descending decisions.

  Day 1 to Day 21 after first dose (21 days)

• Number of subjects with adverse events (AEs)

  AEs will be characterized by type, seriousness, relationship to study treatment, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) and timing.

  From screening (Day -28 to Day -1) through up to 12 months or until disease progression

Secondary Outcomes (8)

• Pharmacokinetic Assessments: Time to maximum plasma concentration (Tmax)

  PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)

• Pharmacokinetic Assessments: Maximum concentration (Cmax)

  PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)

• Pharmacokinetic Assessments: Elimination half-life (t1/2)

  PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)

• Pharmacokinetic Assessments: Area under the concentration-time curve over time 0 to t (AUC0-t)

  PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)

• Pharmacokinetic Assessments: Area under the concentration-time curve over time 0 to infinite (AUC0-inf)

  PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)

Study Arms (1)

RGT-264 monotherapy

EXPERIMENTAL

The study is composed of dose escalation stage and dose expansion stage. RGT-264 will be administered orally daily alone as monotherapy in both stages. In the dose escalation stage, the subjects will receive once daily of RGT-264 monotherapy across approximately 6 ascending dose levels. The starting dose is 10 mg/day. In the dose expansion stage, the subjects will receive RGT-264 treatment at the recommended dose from dose escalation part.

Drug: RGT-264 phosphate tablets

Interventions

RGT-264 phosphate tablets DRUG

RGT-264 phosphate tablets will be administered orally once daily (QD).

RGT-264 monotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regor Pharmaceuticals Inc.: lead

Study Sites (3)

The First Affiliated Hospital Of Nanchang University City

Nanchang, Jiangxi, 330006, China

Location

Shandong Provincial Institute of Cancer Prevention and Treatment

Jinan, Shandong, 250117, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be one arm in the study. Enrolled subjects will be treated with RGT-264 phosphate tablets alone.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: March 13, 2023
• Study Start: February 15, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)