Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-26

Study Completion Date

2028-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main goal of this first-in-human (FIH) study is to learn about the safety and dosing of GS-2121 when given alone or in combination with zimberelimab (ZIM) in participants with advanced solid tumors.

The primary objectives of this study are:

* To assess the safety and tolerability of GS-2121 as monotherapy and GS-2121 in combination with zimberelimab 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-2121 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors

NCT07213609

Neoplasms, Colorectal Neoplasms

RECRUITING PHASE1/PHASE2

Gefitinib and Docetaxel in Treating Patients With Advanced Solid Tumors

NCT00084786

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function

NCT00118170

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Burkitt Lymphoma +42 more

COMPLETED PHASE1

Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 and Temsirolimus in Treating Patients With Advanced Solid Tumors

NCT01198184

Endometrial Papillary Serous Carcinoma Recurrent Endometrial Carcinoma Recurrent Renal Cell Cancer +5 more

COMPLETED PHASE1

A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer

NCT06580938

Non Small Cell Lung Cancer Bladder Cancer Renal Cell Carcinoma +3 more

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A: GS-2121 Monotherapy Dose Escalation

Participants will receive escalating doses of GS-2121 monotherapy until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol.

Group Type EXPERIMENTAL

GS-2121

Intervention Type DRUG

Tablet administered orally

Part B: GS-2121 Monotherapy Dose Expansion

Participants with selected indications will receive GS-2121 monotherapy at the recommended dose for expansion.

Group Type EXPERIMENTAL

GS-2121

Intervention Type DRUG

Tablet administered orally

Part C: Combination Dose Escalation of GS-2121 with Zimberelimab

Participants will receive escalating doses of GS-2121 in combination with zimberelimab until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol.

Group Type EXPERIMENTAL

GS-2121

Intervention Type DRUG

Tablet administered orally

Zimberelimab

Intervention Type DRUG

Administered intravenously

Part D: Combination Dose Expansion of GS-2121 with Zimberelimab

Participants with selected indications will receive GS-2121 at the recommended dose for expansion in combination with zimberelimab.

Group Type EXPERIMENTAL

GS-2121

Intervention Type DRUG

Tablet administered orally

Zimberelimab

Intervention Type DRUG

Administered intravenously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GS-2121

Tablet administered orally

Intervention Type DRUG

Zimberelimab

Administered intravenously

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GS-0122 AB122

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants diagnosed with histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
* Tissue requirements:

1. Parts A-D: Pretreatment tumor tissue is required.
2. Parts A and C backfill cohorts: Participants must agree to fresh pre- and on-treatment biopsies.
* Adequate organ function.

Exclusion Criteria

* Positive serum pregnancy test or participant who is breastfeeding.
* Requirement for ongoing therapy with any prohibited medications.
* Any anti-cancer therapy, whether investigational or approved within protocol specified time prior to initiation of study including: major surgery (\<4 weeks), experimental therapy (\<21 days or \<5 half-lives whichever is longer), approved immunotherapy or biologic therapy (\<28 days), approved chemotherapy (\<21 days or \<42 days for mitomycin or nitrosoureas), approved targeted small molecule therapy (\<14 days or \<5 half-lives whichever is longer), hormonal therapy or other adjunctive therapy for cancers other than cancer under evaluation in this study (\<14 days) or radiation therapy (\<21 days).
* Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.
* Have not recovered (ie, returned to Grade 1 or baseline) from AEs due to a previously administered agent.
* Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD).
* Diagnosis of immunodeficiency, either primary or acquired.
* History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study treatment.
* Have an active second malignancy.
* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
* History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).
* Ascites or pleural effusion that is symptomatic and/or requiring medical intervention.
* Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV.
* Meet any of the following criteria for cardiac disease: Myocardial infarction or unstable angina pectoris within 6 months of enrollment. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication). Mean QT interval corrected for heart rate using the Fridericia's formula (QTcF) ≥ 470 msec. New York Heart Association Class \> III congestive heart failure or known left ventricular ejection fraction \< 40%.
* Live vaccines within 28 days of initiation of study drug(s).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No