Description:
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.
Title
- Brief Title: A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
- Official Title: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)
Clinical Trial IDs
- ORG STUDY ID:
213348
- SECONDARY ID:
4020-01-001
- NCT ID:
NCT02817633
Conditions
Interventions
Drug | Synonyms | Arms |
---|
TSR-022 | | Part 1a: TSR-022 monotherapy |
Nivolumab | | Part 1b: TSR-022 in combination with nivolumab |
TSR-042 | | Part 1c: TSR-022 in combination with TSR-042 |
TSR-033 | | Part 1d: TSR-022 in combination with TSR-042 and TSR-033 |
Docetaxel | | Part 1f: TSR-022 in combination with TSR-042 and Docetaxel |
Pemetrexed | | Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin. |
Cisplatin | | Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin. |
Carboplatin | | Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin. |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Part 1a: TSR-022 monotherapy | Experimental | | |
Part 1b: TSR-022 in combination with nivolumab | Experimental | | |
Part 1c: TSR-022 in combination with TSR-042 | Experimental | | |
Part 1d: TSR-022 in combination with TSR-042 and TSR-033 | Experimental | | |
Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1) | Experimental | | |
Part 1f: TSR-022 in combination with TSR-042 and Docetaxel | Experimental | | |
Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin. | Experimental | | - TSR-022
- TSR-042
- Pemetrexed
- Cisplatin
|
Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin. | Experimental | | - TSR-022
- TSR-042
- Pemetrexed
- Carboplatin
|
Part 2: Cohort A Melanoma-TSR-022 as monotherapy | Experimental | | |
Part 2: Cohort A Melanoma-TSR-022 with TSR-042 | Experimental | | |
Part2:CohortB Non-small cell lung cancer-TSR-022-monotherapy | Experimental | | |
Part2:CohortB Non-small cell lung cancer-TSR-022 with TSR-042 | Experimental | | |
Part2:CohortC Colorectal cancer-TSR-022 as monotherapy | Experimental | | |
Part2:CohortC Colorectal cancer-TSR-022 with TSR-042 | Experimental | | |
Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC) | Experimental | | |
Eligibility Criteria
Inclusion 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 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-PD-(L)1 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-(L)1 therapy.
- Biopsies - 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.
Exclusion 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, nonmalignant 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.
Exclusion Criteria for Participants in Part 2 Cohort D
- 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 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Part 1: Number of participants achieving dose limiting toxicity (DLTs) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of participants with anti-TSR-022, anti-TSR-042 and anti-TSR-033 antibodies |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Part 1: ORR by RECIST v 1.1 and immune-related RECIST (irRECIST) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Parts 1 and 2: Duration of response (DOR) by RECIST v 1.1 and irRECIST |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1 and irRECIST |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Parts 1 and 2: Progression-free survival (PFS) by RECIST v 1.1 and irRECIST |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Parts 1 and 2: Overall survival (OS) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Part 1a: Maximum plasma concentration (Cmax) of TSR-022 when administered as monotherapy |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose. |
Safety Issue: | |
Description: | |
Measure: | Part 1b: Cmax of TSR-022 in combination with nivolumab |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1c: Cmax of TSR-022 when administered in combination with TSR-042 |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1d: Cmax of TSR-022 when administered in combination with TSR-042 and TSR-033 |
Time Frame: | Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1e: Cmax of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1f: Cmax of TSR-022 in combination with TSR-042 and docetaxel |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1g: Cmax of TSR-022 in combination with TSR-042, pemetrexed and cisplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1h: Cmax of TSR-022 in combination with TSR-042, pemetrexed, and carboplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 2: Cmax of TSR-022 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1b: Cmin of TSR-022 in combination with nivolumab |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1c: Cmin of TSR-022 in combination with TSR-042 |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose. |
Safety Issue: | |
Description: | |
Measure: | Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033 |
Time Frame: | Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1e: Cmin of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1f: Cmin of TSR-022 in combination with TSR-042 and docetaxel |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1g: Cmin of TSR-022 in combination with TSR-042, pemetrexed and cisplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1h: Cmin of TSR-022 in combination with TSR-042, pemetrexed and carboplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 2: Cmin of TSR-022 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042 |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033 |
Time Frame: | Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1e: AUC (0-inf) of in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1f: AUC (0-inf) of TSR-022 in combination with TSR-042 and docetaxel |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1g: AUC (0-inf) of TSR-022 in combination with TSR-042, pemetrexed and cisplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1h: AUC (0-inf) of TSR-022 in combination with TSR-042, pemetrexed and carboplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 2: AUC (0-inf) of TSR-022 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1a: Area under the concentration × time curve at steady state (AUCss) of TSR-022 as monotherapy |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1b: AUCss of TSR-022 in combination with nivolumab |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1c: AUCss of TSR-022 in combination with TSR-042 |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1d: AUCss of TSR-022 in combination with TSR-042 and TSR-033 |
Time Frame: | Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1e: AUCss of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1f: AUCss of TSR-022 in combination with TSR-042 and docetaxel |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1g: AUCss of TSR-022 in combination with TSR-042, pemetrexed and cisplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1h: AUCss of TSR-022 in combination with TSR-042, pemetrexed and carboplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 2: AUCss of TSR-022 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1a: Maximum plasma concentration at steady state (Cmax,ss) of TSR-022 as monotherapy |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1b: Cmax,ss of TSR-022 in combination with nivolumab |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1c: Cmax,ss of TSR-022 in combination with TSR-042 |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1d: Cmax,ss of TSR-022 in combination with TSR-042 and TSR-033 |
Time Frame: | Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1e: Cmax,ss of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1f: Cmax,ss of TSR-022 in combination with TSR-042 and docetaxel |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1g: Cmax,ss of TSR-022 in combination with TSR-042, pemetrexed and cisplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1h: Cmax,ss of TSR-022 in combination with TSR-042, pemetrexed and carboplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 2: Cmax,ss of TSR-022 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1a: Minimum plasma concentration at steady state (Cmin,ss) of TSR-022 022 as monotherapy |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1b: Cmin,ss of TSR-022 in combination with nivolumab |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1c: Cmin,ss of TSR-022 in combination with TSR-042 |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1d: Cmin,ss of of TSR-022 in combination with TSR-042 and TSR-033 |
Time Frame: | Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1e: Cmin,ss of of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1f: Cmin,ss of of TSR-022 in combination with TSR-042 and docetaxel |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1g: Cmin,ss of TSR-022 in combination with TSR-042, pemetrexed and cisplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1h: Cmin,ss of TSR-022 in combination with TSR-042, pemetrexed and carboplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 2: Cmin,ss of TSR-022 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042 |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033 |
Time Frame: | Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1e: AUC (0-last) of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1f: AUC (0-last) of TSR-022 in combination with TSR-042 and docetaxel |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1g: AUC (0-last) of TSR-022 in combination with TSR-042, pemetrexed and cisplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1h: AUC (0-last) of TSR-022 in combination with TSR-042, pemetrexed and carboplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 2: AUC (0-last) of TSR-022 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1a: Clearance (CL) of TSR-022 as monotherapy |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1b: CL of TSR-022 in combination with nivolumab |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1c: CL of TSR-022 in combination with TSR-042 |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1d: CL of TSR-022 in combination with TSR-042 and TSR-033 |
Time Frame: | Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1e: CL of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1f: CL of TSR-022 in combination with TSR-042 and docetaxel |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1g: CL of TSR-022 in combination with TSR-042, pemetrexed and cisplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1h: CL of TSR-022 in combination with TSR-042, pemetrexed and carboplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 2: CL of TSR-022 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1a: Volume of distribution (Vz) of TSR-022 as monotherapy |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1b: Vz of TSR-022 and in combination with nivolumab |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1c: Vz of TSR-022 in combination with TSR-042 |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1d: Vz of TSR-022 in combination with TSR-042 and TSR-033 |
Time Frame: | Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1e : Vz of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1f: Vz of TSR-022 in combination with TSR-042 and docetaxel |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1g: Vz of TSR-022 in combination with TSR-042, pemetrexed and cisplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1h: Vz of TSR-022 in combination with TSR-042, pemetrexed and carboplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 2: Vz of TSR-022 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1a: Terminal half life (1/2) TSR-022 as monotherapy |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1b: t1/2 of TSR-022 and in combination with nivolumab |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1c: t1/2 TSR-022 in combination with TSR-042 |
Time Frame: | Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1d: t1/2 TSR-022 in combination with TSR-042 and TSR-033 |
Time Frame: | Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1e: t1/2 TSR-022 in combination with TSR-042 in participants not previously treated with PD-(L)1 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1f: t1/2 of TSR-022 in combination with TSR-042 and docetaxel |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1g: t1/2 of TSR-022 in combination with TSR-042, pemetrexed and cisplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 1h: t1/2 of TSR-022 in combination with TSR-042, pemetrexed and carboplatin |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Measure: | Part 2: t1/2 of TSR-022 |
Time Frame: | Pre-dose, 0.25, 0.5 hour post dose |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Tesaro, Inc. |
Trial Keywords
- TSR-022
- Nivolumab
- Cobolimab
- Advanced solid tumors
- Metastatic solid tumors
- Immunotherapy
- PD-1
- Anti-PD-1
- Colorectal cancer
- Non-small cell lung cancer
- Melanoma
- TSR-033
- TSR-042
- Dostarlimab
Last Updated
June 8, 2021