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

Status
Active
Cancer Type
Colon/Rectal Cancer
Lung Cancer
Melanoma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02817633
Protocol IDs
4020-01-001 (primary)
NCI-2016-01254
Study Sponsor
Tesaro Inc

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.

Eligibility

  1. Participant is at least 18 years of age.
  2. 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.
  3. Participant has an ECOG performance status of less than or equal to (<=)1.
  4. Participant has adequate organ function. Inclusion Criteria for Participants in Part 1 and Part 2 Cohorts A, B, and C:
  5. 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:
  6. 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
  7. Inclusion Criteria for Participants in Part 2 Cohort D
  8. Participants with advanced or metastatic NSCLC that is measurable by CT or MRI per RECIST version 1.1 criteria and meet the following criteria:
  9. NSCLC histology includes squamous or non-squamous cell carcinoma.
  10. 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.
  11. 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.
  12. 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 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.