A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GS-1811, an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination with an anti-PD-1 Monoclonal Antibody in Adults with Advanced Solid Tumors
A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GS-1811, an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination with an anti-PD-1 Monoclonal Antibody in Adults with Advanced Solid Tumors
NCT #
NCT05007782
Condition(s)
Breast, Cervical, Colorectal, Cutaneous Squamous Cell Carcinoma, esophageal Squamous Cell Carcinoma, Gastric/GEJ (Gastroesophageal Junction)/Esophageal, head and neck squamous cell carcinoma, Non-Small Cell Lung, Vaginal, Vulvar Carcinoma
Molecular Target(s)
CCR8
Drug Classification(s)
Monoclonal Antibody
Agents(s)
monoclonal antibody
Phase(s)
I
Mechanism of Action
GS-GS-1811 is a monoclonal antibody that is designed to bind to CCR8. It is thought to target Tumor-Infiltrating T Regulatory cells for depletion by enhancing an antibody-dependent cellular cytotoxicity mechanism
Purpose
- How much of the study agent when given alone or in combination with Zimberelimab can be given with an acceptable level of side effects
- About the safety, tolerability, and effectiveness of the study agent when given alone or in combination with Zimberelimab
- Whether the study agent in combination with Zimberelimab or Zimberelimab alone is more effective
- How much of the study agent is absorbed into your blood and how fast it is removed from your blood
- If research tests can be used in the future to predict who will benefit from GS1811
- How your body responds to taking GS-1811 alone or in combination with Zimberelimab.
- 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 treatment known to confer clinical benefit or whose disease is indicated for anti-PD-(L)1 monoclonal antibody monotherapy.
- Part D: Individuals with pathologically confirmed select advanced solid tumors.
- Part E: Individuals with pathologically confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatment known to confer clinical benefit.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 for individuals in Parts A, B, and C, and 0 or 1 for individuals in Parts D and E.
- 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:
- Parts A, C, D and E: 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.
- 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.
- Concurrent active malignancy other than nonmelanoma skin cancer, curatively resected carcinoma in situ, localized prostate cancer, 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) on 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 (excluding localized 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 first dose.
- Significant cardiovascular disease.
- First-line HNSCC:
- Participants have not received prior systemic treatment administered in the
recurrent or metastatic setting. Systemic therapy which was completed more than
6 months prior to signing consent if given as part of multimodal treatment for
locally advanced disease is allowed. - Participants have not received prior immuno-oncology (IO)-directed neoadjuvant
and/or adjuvant therapy including but not limited to any anti-PD-(L)1 mAb.
- Participants have not received prior systemic treatment administered in the
- Second- and third-line NSCLC:
- Disease progression on or after at least 1 but no more than 2 prior therapies.
Previous treatments must have included platinum-based chemotherapy in
combination with an anti–PD-(L)1 mAb OR platinum-based chemotherapy and
anti–PD-(L)1 mAb therapy (in either order) sequentially. An additional line of
treatment is allowed for participants with 1 prior therapy of platinum-based
chemotherapy in combination with an anti–PD-(L)1 mAb.
- Disease progression on or after at least 1 but no more than 2 prior therapies.
- Second- and third-line gastric and EGJ adenocarcinoma:
- Disease progression on or after at least 1 but no more than 2 prior therapies.
Previous treatment must have included platinum-fluoropyrimidine-based
chemotherapy in combination with an anti–PD-(L)1 mAb OR
platinum-fluoropyrimidine-based chemotherapy and anti–PD-(L)1 mAb (in either
order) sequentially. An additional line of treatment is allowed for participants
with 1 prior therapy of platinum-fluoropyrimidine-based chemotherapy in
combination with an anti–PD-(L)1 mAb.
- Disease progression on or after at least 1 but no more than 2 prior therapies.
- MSS mCRC:
- Participants have been previously treated with or are not considered candidates
for available therapies including fluoropyrimidine-, oxaliplatin- and
irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents
(if RAS wild-type). - Participant’s prior therapies may include either trifluridine and tipiracil, or
regorafenib, but not both.
- Participants have been previously treated with or are not considered candidates
Location
MCD
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