Health TrialsbyHealthPanel

Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors

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

About this trial

This is a first-in-human (FIH) study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of denikitug (also known as GS-1811) as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.

This study will be conducted in 6 parts (Parts A, B, and E: monotherapy, Parts C and D: combination therapy, and Part F for both monotherapy and combination therapy) in participants with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or in participants with select solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Part A: 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.

Part B: 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.

Part C: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or whose disease is indicated for anti- programmed cell death protein 1 or programmed cell death ligand 1 (PD-[L]1) monoclonal antibody monotherapy.

Part D: Individuals with pathologically confirmed select advanced solid tumors.

Disqualifiers

Concurrent anticancer treatment.

Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (< 14 days), hormonal therapy or other adjunctive therapy (< 14 days) or radiotherapy (< 21 days).

Any prior CCR8 directed therapy.

Prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Denikitug

    Drug

    Administered Intravenously

  • Zimberelimab

    Drug

    Administered Intravenously

Treatment groups

416 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A - Denikitug Dose EscalationExperimental treatment 1 intervention
Group B: Part B - Mandatory Paired Tumor BiopsyExperimental treatment 1 intervention
Group C: Part C: Denikitug + Zimberelimab Dose EscalationExperimental treatment 2 interventions
Group D: Part D: Denikitug + Zimberelimab Dose ExpansionExperimental treatment 2 interventions
Group E: Part E: Denikitug Monotherapy Dose ExpansionExperimental treatment 1 intervention
Group F: Part F: Denikitug Monotherapy and In Combination With Zimberelimab In Select Dose and ScheduleExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C

Time frame
Day 1 Through Day 21
2

Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Time frame
First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
3

Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0

Time frame
First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days

Secondary outcomes

1

Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for Denikitug

Time frame
Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
2

PK Parameter: Minimum Observed Concentration (Cmin) for Denikitug

Time frame
Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
3

PK Parameter: Time of Maximum Observed Concentration (Tmax) for Denikitug

Time frame
Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
4

PK Parameter: Area Under the Concentration-time Curve (AUC) for Denikitug

Time frame
Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days

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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