A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)

Eligibility Criteria

• * History of Grade greater than or equal to (\>=)3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
• * Participant has known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis.
• * Participant has a known additional malignancy that progressed or required active treatment within the last 2 years. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the Medical Monitor.
• * Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active infection requiring systemic therapy.
• * Participant is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 150 days after the last dose of study treatment.
• * Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
• * A participant with negative (as determined by Central Testing Lab) or unevaluable TIM-3 expression from tissue obtained prior to study entry will not be eligible for the study.
• * Participant has received prior therapy as defined below:
• * Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent that resulted in permanent discontinuation due to an AE.
• * Prior treatment with an anti-lymphocyte activation gene (LAG)-3 or anti-TIM-3.
• * Radiologic or clinical progression \<= 8 weeks after initiation of prior anti-PD-1 or anti-PD-L1 antibody.
• * Participants with known epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) translocation, or receptor tyrosine kinase (ROS1) mutation.
• * Participant has received a vaccine other than a vaccine against severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) infection ("Coronavirus Disease 2019" \[COVID-19\]) within 7 days of planned start of study therapy. The use of all COVID-19 vaccines is allowed, with the exception of COVID-19 vaccines using the recombinant adenoviral vector platform within 30 days of planned start of study therapy. If a COVID-19 vaccine using this platform is to be administered within 30 days of planned start of study therapy, this must first be discussed with and approved by the Sponsor's Medical Monitor.
• * Participant has been previously treated with an anti PD 1, anti PD L1, or anti PD L2 agent that resulted in permanent discontinuation due to an AE
• * Participant has been previously treated with an anti TIM-3 or anti cytotoxic T lymphocyte-associated protein 4 (CTLA 4) agent or docetaxel.
• * Participant has a documented sensitizing EGFR, ALK, or ROS-1 mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.
• * Participant had radiological or clinical disease progression (that is \[ie,\] worsening performance status, clinical symptoms, and laboratory data) \<=8 weeks after initiation of prior anti PD 1 or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan.
• * Participant has received radiation to the lung that is \>30 Gray (Gy) within 6 months prior to the first dose of study treatment.
• * Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.
• * Participant has an additional malignancy or a history of prior malignancy, with the exception of adequately treated basal or squamous skin cancer, cervical carcinoma in situ, or bladder carcinoma in situ without evidence of disease, or had a malignancy treated with curative intent and with no evidence of disease recurrence for 5 years since the initiation of that therapy.
• * Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiologically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment.
• * Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment:
• * Presence of hepatitis B surface antigen.
• * Presence of hepatitis C antibody in the absence of an Ribonucleic acid (RNA) test for hepatitis C virus.
• * Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
• * Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy of prednisone, or equivalent, for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
• * Participant has received systemic steroid therapy within 3 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy. Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.
• * Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary.
• * Participant does not meet requirements per local prescribing guidelines for receiving treatment with docetaxel, including severe hypersensitivity reactions to drugs formulated with polysorbate 80.
• * Participant has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days, or less than 5 times the half life of the most recent therapy prior to study Day 1, whichever is shorter.
• * Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
• * Participant must not have had major surgery \<= 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
• * Participants must not have received investigational therapy \<= 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy.
• * Active or untreated central nervous system (CNS) and leptomeningeal metastases
• * Prior therapy with any medication targeting PD-1, PD-L1, or TIM-3
• * Participant must not have a known hypersensitivity to TSR-042 and TSR-022 components or excipients.
• * Participants with active malignancy (other than HCC) or a prior malignancy within the past 2 years are excluded. Participants with completely resected cutaneous melanoma (early stage), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and localized prostate cancer are eligible
• * Participant must not have serious, uncontrolled medical disorder, or nonmalignant systemic disease as determined by the treating physician. Examples include, but are not limited to uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
• * Has a history or evidence of cardiac abnormalities within the 6 months prior to enrollment, including:
• * Serious, uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second-degree (Type II) or third-degree atrioventricular (AV) block.
• * Cardiomyopathy, myocarditis, myocardial infarction, acute coronary syndromes (including angina pectoris), coronary angioplasty, stenting, or bypass grafting.
• * Congestive heart failure \[New York Heart Association (NYHA) Class III or IV\]
• * Symptomatic pericarditis
• * Known history of HIV infection
• * Active tuberculosis infection or other microbial infection or any active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
• * Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (. i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• * History of idiopathic pulmonary fibrosis, interstitial lung disease, bronchial asthma, organizing pneumonia, bronchiolitis obliterans, drug-induced pneumonitis, or idiopathic pneumonitis
• * History of organ transplantation including allogeneic bone marrow transplantation
• * Participant has a diagnosis of immunodeficiency or has been receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy.
• * Participant has received a live vaccine within 7 days of initiating protocol therapy. Seasonal flu vaccines that do not contain live virus and COVID 19 vaccines are permitted.
• * Psychiatric illness/social situations that would limit compliance with study requirements
• * Pregnant, lactating, breastfeeding, or intending to become pregnant during the study and for 150 days after the study