Evaluation of GLR2007 for Advanced Solid Tumors

NCT04444427 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: GLP-CDK-1009
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief Summary

Evaluation of GLR2007 for Advanced Solid Tumors

Conditions

Non-small Cell Lung Cancer; Glioblastoma Multiforme

Keywords

Non-small Cell Lung Cancer; Glioblastoma Multiforme; Breast Cancer; Advanced Solid Tumors; GLR2007

Outcome Measures

Primary Outcomes (3)

• Dose Escalation: Dose-limiting Toxicities

  Up to 12 Months

• Dose Escalation: Incidence And Severity Of Adverse Events, Including The Incidence Of Dose-limiting Toxicities Within The First Cycle

  Up to 12 Months

• Dose Expansion: Incidence And Severity Of Adverse Events

  Up to 96 Weeks

Secondary Outcomes (8)

• Dose Escalation: Objective Response Rate

  8 Weeks

• Dose Expansion: Objective Response Rate

  12, 24, 36, 48, 60, 72, 84, and 96 Weeks

• Dose Escalation And Expansion: Maximum Observed Plasma Concentration After Single And Multiple Oral Dose Administrations

  0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose

• Dose Escalation And Expansion: Time At Which Maximum Plasma Concentration Is Observed And Apparent Half-life After Single And Multiple Oral Dose Administrations

  0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose

• Dose Escalation And Expansion: Area Under The Plasma Concentration-time Curve From 0 To Last Measurable Concentration And From 0 To Infinity After Single And Multiple Oral Dose Administrations

  0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose

Study Arms (4)

Part 1: Dose Escalation

EXPERIMENTAL

Dose escalation cohorts are planned to determine the maximum tolerated dose or recommended phase 2 dose of GLR-2007, as well as expansion cohorts and a Phase 2 cohort.

Drug: GLR2007

Part 2: Dose Expansion - Cohort A

EXPERIMENTAL

Participants who have received 2 or more second-line therapies, with at least 1 line of standard therapy, for their non-small cell lung cancer (NSCLC) will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression.

Drug: GLR2007

Part 2: Dose Expansion - Cohort B

EXPERIMENTAL

Participants who have received 2 or more second-line therapies, with at least 1 line of standard therapy, for their brain metastases of breast or NSCLC origin will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression.

Drug: GLR2007

Part 2: Dose Expansion - Cohort C

EXPERIMENTAL

Participants experiencing their first recurrence glioblastoma multiforme (GBM) will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression.

Drug: GLR2007

Interventions

GLR2007 DRUG

Administered orally, once daily for 21 days followed by a 7-day treatment holiday.

Also known as: GLR2007-237FA

Part 1: Dose Escalation; Part 2: Dose Expansion - Cohort A; Part 2: Dose Expansion - Cohort B; Part 2: Dose Expansion - Cohort C

Eligibility Criteria

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

You may qualify if:

• For Part 1 (Dose Escalation): Participants with advanced solid tumors who are refractory or intolerant to therapies known to provide clinical benefit.
• For Part 1 (Dose Escalation): The participant must have histological or cytological evidence of cancer (a solid tumor) that is advanced and/or metastatic. Biopsy is allowed by protocol if no histology or cytology records are available.
• For Part 2 (Dose Expansion): The participant must have histological or cytological evidence of cancer that is advanced and/or metastatic.
• For Part 1 (Dose Escalation): The participant has measurable or non-measurable disease.
• For Part 2 (Dose Expansion): The participant has measurable disease.
• The participant has given written informed consent prior to all study-specific procedures.
• The participant has adequate hematologic, hepatic, and renal function.
• The participant has discontinued all prior cancer therapies (including chemotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for radiotherapy and non-myelosuppressive agents, prior to receiving GLR2007, and has recovered from the acute effects of therapy (treatment related toxicity resolved to ≤Grade 1) except for residual alopecia.
• The participant is willing and able to make themselves available for the duration of the study and is willing and able to follow study procedures.
• The participant meets contraceptive requirements.
• The participant has an estimated life expectancy of ≥3 months.
• The participant agrees to minimize ultraviolet exposure and sunlight for the duration of their study participation.
• A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed within 28 days prior to registration. Contrast-enhanced computed tomography (CT) is acceptable if MRI is not possible.
• Histologically or cytologically confirmed NSCLC.
• Participants must have received at least 1 line of standard therapy for metastatic disease, including platinum-based chemotherapy and an immune checkpoint inhibitor given together or as separate lines of therapy, unless participants are ineligible for or cannot tolerate such therapy.

You may not qualify if:

• The participant has a personal history of any of the following conditions: major surgical resection involving the stomach or small bowel recurrent, unexplained or cardiac-related syncopal episodes within the last 6 months or ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation).
• Any concurrent malignancies currently requiring treatment or for which treatment would be deemed necessary within 3 months of enrollment; prostate cancer with androgen deprivation therapy, basal cell cancer, and squamous cell cancers are allowed.
• The participant is pregnant or lactating.
• The participant is immunocompromised and known to be human immunodeficiency virus positive. The participant has an active bacterial, fungal, and/or known viral infection (for example, hepatitis B surface antigen or hepatitis C antibodies).
• Part 2 (Cohort A, NSCLC): The participant has NSCLC with worsening symptoms within 14 days prior to receiving GLR2007.
• Part 2 (Cohort B, Brain metastases of breast or NSCLC origin): The participant has CNS metastasis with worsening symptoms within 14 days prior to receiving GLR2007.
• Part 2 (Cohort C, GBM): The participant has GBM with worsening symptoms within 14 days prior to receiving GLR2007.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (4)

USA002

Lafayette, Indiana, 47905, United States

Location

USA005

Omaha, Nebraska, 68130, United States

Location

USA001

Philadelphia, Pennsylvania, 19111, United States

Location

USA004

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Glioblastoma; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kimberly Lazaroff, MSN

  Gan and Lee Pharmaceuticals, USA Corp

  STUDY DIRECTOR

Study Design

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

Model Details: Part 1 employs a dose-escalation design to determine the recommended phase 2 dose. This is followed by Part 2, which involves parallel dosing of 3 different cohorts at the dose determined in Part 1.

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: July 15, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)