Health TrialsbyHealthPanel

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

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGilead Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Parts A-D: Pre-treatment tumor tissue is required.

Disqualifiers

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 shorter), 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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GS-2121

    Drug

    Tablet administered orally

  • Zimberelimab

    Drug

    Administered intravenously

Treatment groups

154 Participants
are divided into 4 treatment groups
Group A: Part A: GS-2121 Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part B: GS-2121 Monotherapy Dose ExpansionExperimental treatment 1 intervention
Group C: Part C: Combination Dose Escalation of GS-2121 with ZimberelimabExperimental treatment 2 interventions
Group D: Part D: Combination Dose Expansion of GS-2121 with ZimberelimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse Events

Time frame
First dose up to 90 days post last dose (up to approximately 118 weeks)
2

Parts A and B: Percentage of Participants with Laboratory Abnormalities

Time frame
First dose up to 90 days post last dose (up to approximately 118 weeks)
3

Part A: Percentage of Participants with Dose-Limiting Toxicities (DLTs) During Dose Escalation

DLTs are defined as any of the protocol-specified treatment-emergent adverse events (AEs) with onset within the DLT-evaluation period for the corresponding dose.

Time frame
Day 1 up to Day 21
4

Parts C and D: Percentage of Participants with Adverse Events and Serious Adverse Events

Time frame
First dose up to 90 days post last dose (up to approximately 118 weeks)

Secondary outcomes

1

Parts A and B: Plasma Concentration of GS-2121 and Active Metabolite

Time frame
Predose and postdose up to end of treatment (up to 105 weeks)
2

Parts A and B: PK Parameter: AUC0-24 of GS-2121

AUC0-24 is defined as the partial area under the concentration of drug over time between time 0 and time 24 hours. PK parameters will be estimated as applicable, based on the availability of data.

Time frame
Predose and postdose up to end of treatment (up to 105 weeks)
3

Parts A and B: PK Parameter: Cmax of GS-2121

Cmax is defined as the maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.

Time frame
Predose and postdose up to end of treatment (up to 105 weeks)
4

Parts A and B: PK Parameter: Tmax of GS-2121

Tmax is defined as the time to maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.

Time frame
Predose and postdose up to end of treatment (up to 105 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gilead Sciences

Lead sponsor

Source ClinicalTrials.gov
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