Trial Title:
Study of GS-4528 in Adults With Solid Tumors
NCT ID:
NCT05840224
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
GS-4528
Description:
Administered intravenously
Arm group label:
Phase 1a: GS-4528 Monotherapy Dose Escalation
Arm group label:
Phase 1a: GS-4528 Monotherapy Dose Expansion
Arm group label:
Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab)
Intervention type:
Drug
Intervention name:
Zimberelimab
Description:
Administered intravenously.
Arm group label:
Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab)
Summary:
The goals of this clinical study are to identify if GS-4528 alone or in combination with
anti-programmed cell death protein 1 (PD-1) (Anti-PD-1) Monoclonal Antibody is safe and
tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for
further development that is safe to give to people alone or in combination with Anti-PD-1
Monoclonal Antibody.
The primary objectives of this study are:
- To assess the safety and tolerability of GS-4528 as monotherapy and in combination
with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors.
- To identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or
the recommended Phase 2 dose (RP2D) of GS-4528 as monotherapy and in combination
with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Documented disease:
- Phase 1a dose escalation and backfill cohorts; Phase 1b dose escalation:
Individuals with histologically or cytologically confirmed advanced solid
tumors who have received, been intolerant to, or been ineligible for all
treatment known to confer clinical benefit or have a contraindication to
receive the therapy.
- Phase 1a dose expansion: Individuals with histologically or cytologically
confirmed select indications who have received, been intolerant to, or been
ineligible for all treatment known to confer clinical benefit or have a
contraindication to receive the therapy.
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
criteria.
- Adequate organ function.
- Individuals of childbearing potential who engage in heterosexual intercourse must
agree to use method(s) of contraception.
- Tissue requirements:
- Phase 1a dose escalation, Phase 1a dose expansion, and Phase 1b dose
escalation: Must provide pre-treatment adequate tumor tissue sample prior to
enrolment.
- Phase 1a backfill cohorts: Individuals must have fresh pre-treatment and
on-treatment biopsy for biomarker analysis.
- Life expectancy ≥ 3 months.
Key Exclusion Criteria:
- Positive serum pregnancy test or lactating female.
- Prohibited concurrent anticancer therapy listed in the protocol.
- Any anti-cancer therapy, whether investigational or approved, within protocol
specified time prior to initiation of study including: major surgery (<28 days),
immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted
small molecule therapy (< 14 days or < 5 half-lives whichever is shorter), hormonal
therapy or other adjunctive therapy (< 14 days) or radiotherapy (< 21 days).
- Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem
cell transplantation.
- Diagnosis of immunodeficiency, either primary or acquired, or systemic steroid
requirement of > 10 mg of prednisone or equivalent.
- History of intolerance, hypersensitivity, or treatment discontinuation due to severe
immune-related adverse events (irAEs) on prior immunotherapy.
- History of autoimmune disease or active autoimmune disease that has required
systemic treatment within 2 years prior to the start of study treatment.
- Concurrent active second malignancy. Note: Individuals with a history of malignancy
that have been completely treated, with no evidence of active cancer for 2 years
prior to enrollment, or participants with surgically cured tumors with low risk of
recurrence are allowed to enroll.
- Have known active central nervous system (CNS) metastases and/ or carcinomatous
meningitis.
- Significant cardiovascular disease.
- Have active serious infection requiring antibiotics.
- Have active hepatitis B virus (HBV), hepatitis C virus (HCV), or human
immunodeficiency virus (HIV).
- History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis
(excluding localized radiation pneumonitis).
- Symptomatic ascites or pleural effusion.
- Live vaccines within 28 days of initiation of investigational product(s).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Washington/FHCC
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Facility:
Name:
The Ottawa Hospital
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
University Health Network, Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health Systems
Address:
City:
Seoul
Zip:
06273
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall D'Hebron- Oncology Service
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei City
Zip:
100229
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical Foundation
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
St Bartholomew's Hospital
Address:
City:
London
Zip:
E1 1FR
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Start date:
May 11, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Gilead Sciences
Agency class:
Industry
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05840224
https://www.gileadclinicaltrials.com/study?nctid=NCT05840224
