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

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ClinicalTrials.gov Identifier: NCT05764915
Recruitment Status : Recruiting
First Posted : March 13, 2023
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Regor Pharmaceuticals Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: RGT-264 phosphate tablets Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: There will be one arm in the study. Enrolled subjects will be treated with RGT-264 phosphate tablets alone.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of RGT-264 Phosphate Tablets in Subjects With Advanced Solid Tumors
Actual Study Start Date : February 15, 2023
Estimated Primary Completion Date : February 20, 2025
Estimated Study Completion Date : August 2, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Drug: RGT-264 phosphate tablets
RGT-264 phosphate tablets will be administered orally once daily (QD).


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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.

  2. 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 ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    Blood and urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.

  2. 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) ]
    Blood and urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Pharmacokinetic Assessments: Cumulative urinary excretion [ Time Frame: Cycle 1 Day 1 (each cycle is 21 days) ]
    Urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.

  8. 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). ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05764915


Contacts
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Contact: Yan ZHOU 86-021-31168233 yan.zhou@qlregor.com

Locations
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China, Jiangxi
The First Affiliated Hospital Of Nanchang University City Not yet recruiting
Nanchang, Jiangxi, China, 330006
Contact: Jinhua WEN    86 13970823367    Wenjinhua8606@163.com   
Contact: Yong LI    86 15879155066    liyongcsco@qq.com   
China, Shandong
Shandong Provincial Institute of Cancer Prevention and Treatment Not yet recruiting
Jinan, Shandong, China, 250117
Contact: Yuping SUN    86 13370582181    13370582181@163.com   
China, Shanghai
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China, 200120
Contact: Jin LI    86-021-38804518    lijin@csco.org.cn   
Sponsors and Collaborators
Regor Pharmaceuticals Inc.
More Information
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Responsible Party: Regor Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT05764915    
Other Study ID Numbers: RGT-264-101
CTR20223017 ( Other Identifier: CDE )
First Posted: March 13, 2023    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regor Pharmaceuticals Inc.:
Hematopoietic progenitor kinase 1 (HPK1)
Dose Escalation
Dose Expansion
RGT-264
First-in-Human
Additional relevant MeSH terms:
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Neoplasms