NCT02988960

A Study of an Active Drug and an Active Drug, an Immunotherapy, in Subjects With Advanced Solid Tumors

Brief summary

This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of an active drug, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for an active drug when administered as monotherapy or as combination therapy with an active drug in participants with advanced solid tumors.

Interventional study

Status:
Recruiting
Conditions:
Advanced Solid Tumors Cancer
Enrollment:
180 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-862
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Masking:
None (Open Label)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
to 1.

- Participants have adequate bone marrow, kidney and liver function.

- Participants with a history of chronic heart failure or significant cardiovascular
disease must have an echocardiogram or multigated acquisition scan indicating left
ventricular ejection fraction greater than or equal to 45% within 28 days prior to the
first dose of study drug.

- Participants must have creatinine clearance greater than or equal to 50 mL/min as
measured by 24-hour urine or estimated by the Cockcroft-Gault formula.

- Participants must have total bilirubin less than or equal to 1.5 times the upper limit
of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than
or equal to 2.5 times ULN.

- Participants in all monotherapy arms must have an advanced solid tumor that has
progressed on standard therapies known to provide clinical benefit or the participants
are intolerant to such therapies.

- Participants in all combination therapy arms must have recurrent or metastatic NSCLC
and previously received platinum-based therapy and progressed either during or after
anti-programmed death ligand 1 (PDL1)-based therapy. In addition, participants must
have received only one prior immunotherapy.

- The Sponsor may decide to limit the specific tumor types selected or treatment
settings for specific arms based on evidence gathered.

Exclusion Criteria:

- Participant must not have an active or prior documented autoimmune disease in the last
2 years.

- Participant must not have current or prior use of immunosuppressive medication within
14 days prior to the first dose (with certain exceptions).

- Participant must not have a history of primary immunodeficiency, bone marrow
transplantation, chronic lymphocytic leukemia, solid organ transplantation, previous
clinical diagnosis of tuberculosis, inflammatory bowel disease, interstitial lung
disease, or immune-mediated pneumonitis.

- Participant must not have a history of a coagulopathy or a platelet disorder.

- Participant must not have a prior grade greater than or equal to 3 immune-mediated
neurotoxicity or pneumonitis while receiving immunotherapy.

- Participant must not have a known uncontrolled malignancy of the central nervous
system.

- Participants in all combination therapy arms must not have a history of exposure to an
immunotherapy experiencing an immune-mediated adverse event that required permanent
discontinuation of the immunotherapy.

- Female participants must not be pregnant, breastfeeding or considering becoming
pregnant during the study or for at least 3 or 5 months (for monotherapy and
combination therapy participants, respectively) after the last dose of study drug.

- Male participants must not be considering fathering a child or donating sperm during
the study or for at least 3 or 5 months (for monotherapy and combination therapy
participants, respectively) after the last dose of study drug.

- Participant is judged by the investigator to have evidence of hemolysis.

- For Japan only, participants with a history of interstitial lung disease (pneumonitis)
or current interstitial lung disease (pneumonitis).

All the cities where the clinical studies are located

Toronto - M5G 2M9

Ontario