Trial Title:
Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
NCT ID:
NCT06425926
Condition:
Melanoma Stage IV
Solid Tumor
Conditions: Official terms:
Neoplasms
Melanoma
Antibodies
Antibodies, Monoclonal
Conditions: Keywords:
PD-1 resistance
PD-1 resistant/refractory
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GIM-531
Description:
GIM-531 administered orally daily
Arm group label:
Phase 1 Single Agent
Arm group label:
Phase 2 Combination Treatment
Intervention type:
Drug
Intervention name:
Anti-PD-1 monoclonal antibody
Description:
Continued treatment with anti-PD-1 therapy
Arm group label:
Phase 2 Combination Treatment
Summary:
GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed
for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531
exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs).
Detailed description:
GIM531-CT01 is a Phase 1/2 open label, first-in-human, multicenter study. The Phase 1
portion will include a dose escalation with GIM-531 administered as a single agent.
Additionally, there will be a dose expansion portion at the safety-cleared dose levels
with participants allocated 1:1 within the proposed therapeutic range to accrue
additional data for determining the safety profile, pharmacokinetics (PK) profile,
pharmacodynamic (PD) effects and early anti-tumor activity of GIM-531. In Phase 2,
GIM-531will be administered to participants with advanced/metastatic cutaneous melanoma
who have progressed following treatment with an anti-PD-1 therapy.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Written informed consent
- Cytologically or histologically confirmed locally advanced or metastatic solid tumor
that has progressed on standard therapy or for which no standard therapy exist; or
be intolerant of standard therapy
- Have not received an experimental drug within 4 weeks or 5 half-lives (whichever is
shorter) of Screening or already be enrolled in a clinical study
- ECOG performance status 0-1
- Laboratory and ECG assessments within 28 days of enrollment including acceptable
cardiac, renal, and hepatic functions
- Agree to baseline core needle biopsy or archival (within 12 months of screening)
tumor submission; Note: Participants whose only site(s) of disease are in areas
considered moderate or high risk for biopsy complications may be enrolled without a
fresh biopsy upon Sponsor approval.
- Non pregnant participants; female participants of child bearing potential with
non-sterile partners agree to use an effective form of contraception from the time
of first dose of study drug (or 14 days prior to first dose for oral contraception)
until 7 months after the last dose of study drug. Effective forms of contraception
include hormonal (injection or oral), double barrier method, or intrauterine device.
Non-sterile male participants with sexual partners of childbearing potential agree
to use a barrier contraception method and agree to not donate sperm from the time of
first dose of study drug until 4 months after the last dose of study drug.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors
(RECIST) version (v)1.1
Phase 2 Specific Inclusion Criteria (in addition to above inclusion criteria):
- Have confirmed unresectable Stage III or metastatic Stage IV cutaneous melanoma that
has radiographically progressed (as confirmed by imaging assessed by the
Investigator) on an approved first-line single-agent or combination anti-PD-1
therapy
- Receiving anti-PD-1 therapy as their first line of treatment at the time of
enrollment and amenable to continuing anti-PD-1 therapy during the study
Key Exclusion Criteria:
- Ongoing >Grade 1 toxicity from prior therapy according to Common Terminology
Criteria for Adverse Events v5.0 (Note: Grade 2 alopecia and Grade 2 sensory
neuropathy are not exclusionary)
- Has melanoma with documented BRAF mutation (Phase 2 only)
- Has known brain metastases, except participants with the following:
- Brain metastases that have been treated locally and are clinically stable for
at least 4 weeks prior to the first administration of study drug; Note:
Participants receiving steroids for brain metastases must be either off
steroids or on a stable, or decreasing dose, of <10 mg daily of prednisone (or
equivalent) in order to be eligible for enrollment; and
- No ongoing neurological symptoms related to the anatomic location of the brain
metastases.
Note: Neurological symptoms that are considered sequelae to treatment for brain
metastases are allowed.
- Has known structural cardiac disease
- Has known serious arrythmia, serious dysrhythmia, history of long QT syndrome, or
clinically relevant cardiac conduction abnormalities
- Has an active autoimmune disease that has required systemic treatment in the past 2
years (ie, with use of disease modifying agents, corticosteroids, or
immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment and is allowed.
- At time of screening, is receiving systemic steroid therapy (greater than or equal
to 10 mg/day of prednisone or equivalent) or is taking any immunosuppressive
therapy; Note: Use of topical, inhaled, nasal, or ophthalmic steroids is allowed.
- Has active and clinically significant bacterial, fungal, or viral infection,
including known hepatitis B virus (HBV), hepatitis C virus (HCV), or human
immunodeficiency virus (HIV)
- Has a history of, or currently has, an acquired or primary (congenital)
immunodeficiency;
- Has had prior anti-cancer treatment with chemotherapeutic agents or immune
modulating agents within <4 weeks or 5 half-lives, whichever is shorter, prior to
the first dose of study drug.
- Has received a live vaccine within 30 days of first dose of study drug;
- Has had or has planned major surgery within 2 weeks of the first dose of study drug;
- Inability to swallow an oral dose of a medication (eg, oral capsules)
- Is taking medications that are considered strong inducers or inhibitors of CYP2C8 or
CYP3A4/5, P-glycoprotein (P-gp), breast cancer resistant protein (BCRP), or
sensitive substrates of P-gp and BCRP (Appendix C) that cannot be discontinued at
least 1 week prior to first dose of study drug and for the duration of the study.
- Is taking drugs that modify gastric pH, such as proton-pump inhibitors (PPIs) or H2
blockers. Antacids such as calcium carbonate or aluminum hydroxide-based products
are permitted.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Honor Health Research Institute
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew Islas
Phone:
480-583-7474
Email:
anislas@honorhealth.com
Investigator:
Last name:
Rizwan Khawaja, MD
Email:
Principal Investigator
Facility:
Name:
Comprehensive Blood and Cancer Center
Address:
City:
Bakersfield
Zip:
93309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nicole Ward
Phone:
661-862-8548
Email:
nward@cbccusa.com
Investigator:
Last name:
Ravindranath Patel, MD
Email:
Principal Investigator
Facility:
Name:
Providence Medical Foundation
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kendall Karp
Phone:
714-446-5177
Email:
kendall.karp@providence.org
Investigator:
Last name:
Yung Lyou, MD
Email:
Principal Investigator
Facility:
Name:
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Recruiting
Contact:
Last name:
Navid Hafez, MD
Email:
nhafez@theangelesclinic.org
Contact backup:
Last name:
Saba Mukarram
Phone:
310-231-2181
Email:
smukarram@theangelesclinic.org
Investigator:
Last name:
Navid Hafez, MD
Email:
Principal Investigator
Investigator:
Last name:
Omid Hamid, MD
Email:
Sub-Investigator
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ryan Sullivan, MD
Phone:
617-724-4000
Email:
RSULLIVAN7@mgh.harvard.edu
Investigator:
Last name:
Ryan Sullivan, MD
Email:
Principal Investigator
Facility:
Name:
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
Address:
City:
Billings
Zip:
59102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matt Adler
Phone:
406-238-6894
Email:
matt.adler@imail.org
Investigator:
Last name:
Patrick Cobb, MD
Email:
Principal Investigator
Start date:
May 9, 2024
Completion date:
November 2026
Lead sponsor:
Agency:
Georgiamune Inc
Agency class:
Industry
Source:
Georgiamune Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06425926
