Zimberelimab for Solid Cancers
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Gilead Sciences
Must not be taking: Anticancer therapy
Disqualifiers: Pregnancy, Transplantation, Autoimmune, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a new drug, GS-4528, alone or with an immune therapy in people with advanced solid tumors. The goal is to see if it is safe and to find the best dose. The combination aims to help the immune system fight cancer more effectively.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it does prohibit any anti-cancer therapy within a certain time before starting the study. It's best to discuss your current medications with the trial team to understand any specific requirements.
What data supports the effectiveness of the drug Zimberelimab for solid cancers?
Research on similar treatments, like the bispecific antibody MEDI5752 targeting PD-1 and CTLA4, shows that targeting immune checkpoints can lead to durable responses in various tumor types, suggesting potential effectiveness for Zimberelimab, which also targets immune checkpoints.
12345What makes the drug zimberelimab unique for treating solid cancers?
Zimberelimab is unique because it is a fully human monoclonal antibody that targets the PD-1 receptor, which is involved in preventing the immune system from attacking cancer cells. This mechanism is similar to other PD-1 inhibitors but zimberelimab's fully human design may reduce the risk of immune-related side effects compared to other treatments.
678910Eligibility Criteria
Adults with advanced solid tumors who have tried all other treatments without success or can't tolerate them are eligible for this trial. They must be physically capable of daily activities (ECOG status 0 or 1), have measurable disease, proper organ function, and agree to use contraception if applicable. Those with autoimmune diseases, active second cancers, CNS metastases, significant heart issues, serious infections including HIV/HBV/HCV, lung conditions like pneumonitis, symptomatic fluid accumulation in the body cavities, recent vaccinations or pregnancy are excluded.Inclusion Criteria
I can provide fresh biopsy samples before and during treatment for testing.
My organs are working well.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
+6 more
Exclusion Criteria
I have an immune system disorder or need more than 10 mg of steroids daily.
Positive serum pregnancy test or lactating female
Prohibited concurrent anticancer therapy listed in the protocol
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive escalating doses of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody to determine the maximum tolerated dose
Up to 24 months
Multiple visits for dose escalation and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
4-8 weeks
Participant Groups
The study is testing GS-4528 alone and combined with an Anti-PD-1 Monoclonal Antibody to see if they're safe and tolerable for treating solid tumors. It aims to find the highest dose patients can take without severe side effects (MTD/MAD) and recommend a Phase 2 dose (RP2D).
3Treatment groups
Experimental Treatment
Group I: Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab)Experimental Treatment2 Interventions
Participants will receive escalating doses of GS-4528 in combination with anti-PD1 monoclonal antibody (zimberelimab) to determine the maximum tolerated dose of GS-4528 as a combination therapy.
Group II: Phase 1a: GS-4528 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive GS-4528 monotherapy at the dose determined in the escalation phase.
Group III: Phase 1a: GS-4528 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants will receive escalating doses of GS-4528 monotherapy to determine the maximum tolerated dose.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Health Network, Princess Margaret Cancer CentreToronto, Canada
The Ottawa HospitalOttawa, Canada
The University of Washington/FHCCSeattle, WA
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Who Is Running the Clinical Trial?
Gilead SciencesLead Sponsor
References
First-in-Maintenance Therapy for Localized High-Grade Osteosarcoma: An Open-Label Phase I/II Trial of the Anti-PD-L1 Antibody ZKAB001. [2023]We investigated the safety and preliminary efficacy of anti-PD-L1 antibody (ZKAB001) as maintenance therapy for localized patients with high-grade osteosarcoma to reduce the risk of recurrence and metastasis.
MEDI5752 Suppresses Two Immune Checkpoints. [2022]Preliminary data from a phase I trial of MEDI5752, a bispecific antibody targeting both PD-1 and CTLA4, indicate the drug is well tolerated and active, with durable responses seen across diverse tumor types.
A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance. [2023]This phase 1 study (NCT03440437) evaluated the safety, tolerability, pharmacokinetics (PK), and activity of FS118, a bispecific antibody-targeting LAG-3 and PD-L1, in patients with advanced cancer resistant to anti-PD-(L)1 therapy.
Serum Antibody Against NY-ESO-1 and XAGE1 Antigens Potentially Predicts Clinical Responses to Anti-Programmed Cell Death-1 Therapy in NSCLC. [2020]Programmed cell death-1 (PD-1) inhibitors effectively treat NSCLC and prolong survival. Robust biomarkers for predicting clinical benefits of good response and long survival with anti-PD-1 therapy have yet to be identified; therefore, predictive biomarkers are needed to select patients with benefits.
Developing combination immunotherapies against cancer that make sense. [2019]Mechanistic preclinical studies provide a compelling case that combination immunotherapies that target the receptors PD-1 and GITR may demonstrate synergy in human cancer.
Zimberelimab: First Approval. [2022]Zimberelimab (®) is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody being developed by Gloria Biosciences, Arcus Biosciences and Taiho Pharmaceutical Co. for the treatment of various cancers including cervical cancer, non-small cell lung cancer and classical Hodgkin's lymphoma. Based on the results of a phase II trial, zimberelimab was recently approved for marketing in China as treatment for relapsed or refractory classical Hodgkin's lymphoma. This article summarizes the milestones in the development of zimberelimab leading to this first approval.
Efficacy and safety of GLS-010 (zimberelimab) in patients with relapsed or refractory classical Hodgkin lymphoma: A multicenter, single-arm, phase II study. [2022]GLS-010 (zimberelimab) is a novel, fully human, anti-programmed death-1 monoclonal antibody that shows promising efficacy and safety in advanced solid tumors. This trial aimed to evaluate the efficacy and safety of GLS-010 (zimberelimab) in Chinese patients with relapsed or refractory classical Hodgkin lymphoma (r/r-cHL).
Preclinical Characterization of GLS-010 (Zimberelimab), a Novel Fully Human Anti-PD-1 Therapeutic Monoclonal Antibody for Cancer. [2022]Zimberelimab (GLS-010) is a novel fully human monoclonal immunoglobulin G4 (IgG4) against the programmed cell death-1 (PD-1) receptor.
Durvalumab plus tremelimumab in advanced or metastatic soft tissue and bone sarcomas: a single-centre phase 2 trial. [2023]Few standard treatment options are available for patients with metastatic sarcomas. We did this trial to evaluate the efficacy, safety, and changes in the tumour microenvironment for durvalumab, an anti-PD-L1 drug, and tremelimumab, an anti-CTLA-4 drug, across multiple sarcoma subtypes.
First Tissue-Agnostic Drug Approval Issued. [2021]The PD-1 inhibitor pembrolizumab received accelerated approval for adult and pediatric patients with solid tumors that are mismatch repair-deficient or microsatellite instability-high. This is the first time the FDA has greenlighted a drug based not on tumor type, but on a common biomarker.