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Active Not RecruitingPhase 1NCT02817633
Official study title

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

Study summary

This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTSR-022 and Nivolumab

Plus 6 other study approaches.

Who it may be forNeoplasms

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 28, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?89 U.S. locations

Locations may change over time.

Who runs it?Tesaro, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Tesaro, Inc.
Interventions being studied
Drug: TSR-022; Drug: Nivolumab; Drug: TSR-042; Drug: TSR-033; Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Participant is at least 18 years of age.
  • Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication or be of non-childbearing potential.
  • Participant has an ECOG performance status of less than or equal to (\<=)1.
  • Participant has adequate organ function. Inclusion Criteria for Participants in Part 1 and Part 2 Cohorts A, B, and C:
  • Participant with advanced or metastatic solid tumor who meets the requirements for the part of the study/cohort he/she will participate in, as follows:
  • Part 2: Histologically proven advanced (unresectable) or metastatic solid tumor that is measurable by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 criteria Inclusion Criteria for Participants in Part 2 Cohort D
  • Participants with advanced or metastatic non-small cell lung carcinoma (NSCLC) that is measurable by CT or MRI per RECIST version 1.1 criteria and meet the following criteria:
  • NSCLC histology includes squamous or non-squamous cell carcinoma.
  • Participants have received no more than 2 prior lines of therapy, which must include a platinum-based chemotherapy (for example \[e.g.\], cisplatin, carboplatin) and an anti- programmed death-ligand 1 (PD-L1) antibody.
  • Participants must have documented radiographic progression by RECIST version 1.1 criteria on prior anti-programmed cell death protein (PD-1) or anti-PD-L1 therapy.
  • Biopsies -All participants enrolled must undergo a biopsy prior to study entry, and the biopsy tissue must be submitted to the central laboratory for all participants in order to determine T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) expression level prior to first dose. If a participant has had a biopsy prior to entering the 35-day screening period and within approximately 12 weeks of study treatment, that biopsy may be accepted as the Baseline fresh biopsy. Inclusion Criteria for Participants in Part 2 Cohort E
  • Participant is greater than or equal to (\>=)18 years old, is able to understand the study procedures, and agrees to participate in the study by providing written informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and protocol.
  • Participant has histologically or cytologically proven advanced or metastatic NSCLC, and only squamous or non-squamous cell carcinoma.
  • Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum-based (eg, cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or anti-PD-L1 antibody (no other biologic agents alone or in combination; novel combinations are not allowed). Participants previously treated with targeted therapies, including angiogenesis inhibitors (eg, bevacizumab, ramucirumab, lenvatinib), are not eligible.
  • Participant has measurable disease, that is, presenting with at least 1 measurable lesion per RECIST v1.1 as determined by the local site Investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if disease progression has been demonstrated in such lesions and if there are other target lesions. If there is only 1 target lesion that was previously irradiated, the participant is not eligible.
  • Participant has documented radiological disease progression on prior platinum-based chemotherapy and on prior anti-PD-1 or anti-PD-L1 therapy according to RECIST v1.1.
  • Participant agrees to submit an archival formalin fixed paraffin embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease from location(s) not irradiated prior to biopsy. Both tissue block and freshly cut slides are acceptable. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
  • Participant has an ECOG performance status score of 0 or 1.
  • Participant has a life expectancy of at least 3 months and is anticipated to be able to complete 4 cycles of docetaxel treatment.
  • Participant has adequate organ function as defined in the protocol
  • Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Inclusion Criteria for Participants in Part 2 Cohort F
  • Histologically confirmed locally advanced or metastatic and/or unresectable Hepatocellcular Carcinoma (HCC)
  • Barcelona Clinic Liver Cancer Stage B or C
  • Cirrhosis grade of Child-Pugh Class A
  • No prior systemic therapy for HCC
  • Documented HBV testing at screening, including hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAB) and hepatitis B core antibody (HBcAb). Participants with a positive HBsAg will require negative hepatitis B virus (HBV) DNA testing at screening.
  • Participants with chronic HBV infection (HBsAg +) are required to be receiving effective antiviral therapy (i.e., with Tenofovir or Entecavir) for at least 14 days with willingness to continue for the length of the study and have HBV deoxyribonucleic acid (DNA) less than 100 International Units Per Milliliter (IU/mL) within 28 days prior to initiation of study treatment.
  • Participants with chronic HBV infection (HBsAg+) require documented Hepatitis D virus (HDV) antibody testing conducted at screening. If HDV antibody is positive, then HDV ribonucleic acid (RNA) must be negative to participate.
  • Participants with a negative HBsAg and positive HBcAb result are eligible only if HBV DNA is negative (Past HBV participants).
  • Documented hepatitis C virus (HCV) antibody testing conducted at screening. If HCV antibody is positive, then HCV RNA must be negative. Participants with recently treated HCV prior to study start must be greater than (\>)12 weeks from final HCV treatment.
  • Must have measurable disease, defined as at least one tumor lesion that can be accurately measured according to RECIST v1.1
  • Participant agrees to submit an archival FFPE tumor tissue specimen that was collected on or after diagnosis of metastatic disease from location(s) not irradiated prior to biopsy. Both tissue block and freshly cut slides are acceptable. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
  • Participants are also encouraged, but not required, to have a fresh tumor tissue biopsy of a primary or metastatic tumor prior to dosing (samples will be used to enable biomarker analysis).
  • International normalized ratio (INR) or prothrombin time (PT) \<= 2× upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) \<=2×ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Negative human immunodeficiency virus (HIV) test at screening The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • GSK Investigational SiteGoodyear, Arizona
  • GSK Investigational SiteScottsdale, Arizona
  • GSK Investigational SiteTucson, Arizona
  • GSK Investigational SiteTucson, Arizona
  • GSK Investigational SiteEncinitas, California
  • GSK Investigational SiteFountain Valley, California
  • GSK Investigational SiteLos Angeles, California
  • GSK Investigational SiteLos Angeles, California
  • GSK Investigational SiteSan Marcos, California
  • GSK Investigational SiteWhittier, California
  • GSK Investigational SiteAurora, Colorado
  • GSK Investigational SiteAurora, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 28, 2025. Always confirm current availability with the study team.

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