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Monoclonal Antibodies

Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors (CITRINO Trial)

Phase 1

Waitlist Available

Research Sponsored by Tesaro, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 51 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called TSR-033 alone, with dostarlimab, and with other cancer treatments in patients with advanced solid tumors, especially colorectal cancer. The goal is to help the immune system better fight the cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 51 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 51 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 51 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Number of Participants With Grade 3 and 4 Toxicities in Clinical Chemistry Parameters - Creatinine, Bilirubin, Alkaline Phosphatase

Part 1: Number of Participants With Grade Shift From Baseline in Clinical Chemistry Parameters

Part 1: Number of Participants With Grade Shift From Baseline in Hematology Parameters

+11 more

Secondary study objectives

Part 1ab: AUC Extrapolated From Time Zero to Infinity (AUC [0-inf]) of TSR-033

Part 1ab: AUC Over a Dosing Interval at Steady State (AUCtau) of TSR-033

Part 1ab: Area Under the Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC [0-last]) of TSR-033

+22 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part 2 Cohort B2: TSR-033+dostarlimab with FOLFIRIExperimental Treatment4 Interventions

Part 2 Cohort B2 will evaluate the preliminary activity of TSR-033 in combination with FOLFIRI and bevacizumab (SOC) in anti-PD-1 naive second line MSS-CRC participants who have progressed on frontline treatment with FOLFOX, with or without biologics.

Group II: Part 2 Cohort B1: TSR-033+dostarlimab with mFOLFOX6Experimental Treatment4 Interventions

Part 2 Cohort B1 will evaluate the preliminary activity of TSR-033 administered every 2 weeks (Q2W) in combination with dostarlimab administered every 6 weeks (Q6W) along with mFOLFOX6 and bevacizumab (standard of care \[SOC\]) in anti-PD-1 naive second line MSS-CRC participants who have progressed on frontline treatment with FOLFIRI, with or without biologics.

Group III: Part 2 Cohort A: TSR-033+dostarlimab combinationExperimental Treatment2 Interventions

Part 2 Cohort A will evaluate the preliminary activity of TSR-033 in combination with dostarlimab in anti-PD-1 naive participants with third and fourth line MSS-CRC. TSR-033 will be administered every 2 weeks and dostarlimab every 6 weeks.

Group IV: Part 1c: TSR-033+dostarlimab combination dose escalationExperimental Treatment2 Interventions

Participants will be administered ascending doses of TSR-033 in combination with dostarlimab 500 mg every 3 weeks. Planned dose levels of TSR-033 include 80 and 240 mg.

Group V: Part 1b: TSR-033 monotherapy PK/PDy characterizationExperimental Treatment1 Intervention

Part 1b will evaluate the PK profile and assess PDy data from blood and tumor tissue samples following TSR-033 treatment. The participants will begin treatment with TSR-033 on Day 1 followed by 28 days observation for collection of blood sampling for PK/PDy. Participants will receive their second dose of TSR-033 on Day 29 and every 14 days thereafter.

Group VI: Part 1a: TSR-033 monotherapy dose escalationExperimental Treatment1 Intervention

Part 1a will evaluate TSR-033 at ascending doses (20 milligrams \[mg\], 80 mg and 240 mg) every 2 weeks. Cohorts will be enrolled sequentially and will initially follow a 3+3 design at a starting dose of 20 mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FOLFIRI

2005

Completed Phase 3

~5860

Bevacizumab

2013

Completed Phase 4

~5540