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Advanced Solid TumorPhase 1NCT05764915

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

A Phase 1 study testing RGT-264 phosphate tablets in people with Advanced Solid Tumor, run by Regor Pharmaceuticals Inc. at 3 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
RGT-264 phosphate tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
3 sitesChina
Study dates
15 Feb 2023to 20 Feb 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Shandong Provincial Institute of Cancer Prevention and Treatment

    Jinan, Shandong, 250117

  • The First Affiliated Hospital Of Nanchang University City

    Nanchang, Jiangxi, 330006

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

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

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.

Read the 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.

Being tested
RGT-264 phosphate tablets
Keywords
Hematopoietic progenitor kinase 1 (HPK1), Dose Escalation, Dose Expansion, RGT-264, First-in-Human
Medical subject headings
Hereditary Sensory and Autonomic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RGT-264 phosphate tabletsDrug

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

Study groups in NCT05764915
Study groupRoleWhat they receive
RGT-264 monotherapyExperimentalThe 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.
Receives: Drug: RGT-264 phosphate tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (8)

  1. Pharmacokinetic Assessments: Time to maximum plasma concentration (Tmax)

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

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

  2. Pharmacokinetic Assessments: Maximum concentration (Cmax)

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

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

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

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

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

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

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

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

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

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

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

  6. Pharmacokinetic Assessments: Accumulation ratio (Rac)

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

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

  7. Pharmacokinetic Assessments: Cumulative urinary excretion

    Urine samples will be collected for PK analyses for subjects enrolled in dose escalation stage.

    Measured: Cycle 1 Day 1 (each cycle is 21 days)

  8. Tumor Response

    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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start15 Feb 2023
  3. Primary completion20 Feb 2024
  4. Study completion20 Feb 2024

Why it stopped: Due to the change in study plan and not due to safety reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
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)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05764915
Sponsor's protocol ID
RGT-264-101
Other IDs
CTR20223017
Status last verified
Jul 2024
First submitted
11 Jan 2023
Last updated
1 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RGT-264 phosphate tablets in people with Advanced Solid Tumor, run by Regor Pharmaceuticals Inc. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to the change in study plan and not due to safety reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05764915.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.

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