- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05764915
A Phase I Study of RGT-264 in Subjects With Advanced Solid Tumors
January 31, 2024 updated by: Regor Pharmaceuticals Inc.
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of RGT-264 Phosphate Tablets in Subjects With Advanced Solid Tumors
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yan Zhou
- Phone Number: 86-021-31168233
- Email: yan.zhou@qlregor.com
Study Locations
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Jiangxi
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Nanchang, Jiangxi, China, 330006
- The First Affiliated Hospital Of Nanchang University City
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Shandong
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Jinan, Shandong, China, 250117
- Shandong Provincial Institute of Cancer Prevention and Treatment
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Shanghai
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Shanghai, Shanghai, China, 200120
- Shanghai East Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RGT-264 monotherapy
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.
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RGT-264 phosphate tablets will be administered orally once daily (QD).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level in dose escalation stage
Time Frame: Day 1 to Day 21 after first dose (21 days)
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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.
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Day 1 to Day 21 after first dose (21 days)
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Number of subjects with adverse events (AEs)
Time Frame: From screening (Day -28 to Day -1) through up to 12 months or until disease progression
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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.
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From screening (Day -28 to Day -1) through up to 12 months or until disease progression
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic Assessments: Time to maximum plasma concentration (Tmax)
Time Frame: PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
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Blood and urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.
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PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
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Pharmacokinetic Assessments: Maximum concentration (Cmax)
Time Frame: PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
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Blood and urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.
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PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
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Pharmacokinetic Assessments: Elimination half-life (t1/2)
Time Frame: PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
|
Blood and urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.
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PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
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Pharmacokinetic Assessments: Area under the concentration-time curve over time 0 to t (AUC0-t)
Time Frame: PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
|
Blood and urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.
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PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
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Pharmacokinetic Assessments: Area under the concentration-time curve over time 0 to infinite (AUC0-inf)
Time Frame: PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
|
Blood and urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.
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PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
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Pharmacokinetic Assessments: Accumulation ratio (Rac)
Time Frame: PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
|
Blood and urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.
|
PK Blood (Cycle 1 Day 1 and Cycle 1 Day 15; PK Urine (Cycle 1 Day 1) (each cycle is 21 days)
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Pharmacokinetic Assessments: Cumulative urinary excretion
Time Frame: Cycle 1 Day 1 (each cycle is 21 days)
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Urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.
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Cycle 1 Day 1 (each cycle is 21 days)
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Tumor Response
Time Frame: Screening until disease progression, initiation of a new anti-tumor therapy, death, loss to follow-up, withdrawal of consent, or meeting other end-of-study criteria (whichever occurs first) (Assessed up to 12 months).
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Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
The same radiologic imaging techniques for each respective patient will be used throughout.
Tumor response will be assessed by investigator according to RECIST v1.1.
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Screening until disease progression, initiation of a new anti-tumor therapy, death, loss to follow-up, withdrawal of consent, or meeting other end-of-study criteria (whichever occurs first) (Assessed up to 12 months).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2023
Primary Completion (Estimated)
February 20, 2025
Study Completion (Estimated)
August 2, 2025
Study Registration Dates
First Submitted
January 11, 2023
First Submitted That Met QC Criteria
February 28, 2023
First Posted (Actual)
March 13, 2023
Study Record Updates
Last Update Posted (Estimated)
February 2, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RGT-264-101
- CTR20223017 (Other Identifier: CDE)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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