Study to Evaluate the Safety and Tolerability of GS-1811 as Monotherapy and in Combination With Pembrolizumab in Adults With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-1811 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.

This study will be conducted in 2 phases, Phase 1a (Part A and Part B: monotherapy) and Phase 1b (Part C: 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 (Phase 1a and Phase 1b) and whose diseases are indicated for pembrolizumab monotherapy treatment (Phase 1b only).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Pembrolizumab

Criteria

Key Inclusion Criteria:

• Histologically or cytologically confirmed advanced solid tumors

• Part A: Individuals with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit

• Part B: Individuals with select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit

• Part C: Individuals with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or whose disease is indicated for pembrolizumab monotherapy

• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

• Adequate organ function

• Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception

• Tissue requirement:

• Part A and Part C: Must provide pre-treatment adequate tumor tissue sample prior to enrolment

• Part B: Must have fresh pre-treatment and on-treatment biopsy for biomarker analysis

Key Exclusion Criteria:

• 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

• Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer after undergoing potentially curative therapy with no evidence of disease. Individuals with other previous malignancies are eligible if disease-free for > 2 years

• History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) or any life-threatening hypersensitivity to prior immunotherapy

• History of autoimmune disease or active autoimmune disease requiring systemic treatment within 2 years

• History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis

• Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires IV antibiotics

• Active hepatitis B virus (HBV) and/or hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV)

• Positive serum pregnancy test or breastfeeding female

• Live vaccines within 30 days prior to Cycle 1, Day 1 (vector vaccines and messenger RNA (mRNA) vaccines are allowed)

• Significant cardiovascular disease

Note: Other protocol defined Inclusion/Exclusion criteria may apply.