NCT03821935

Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of an Active Drug as a Single Agent and in Combination With an Active Drug in Subjects With Locally Advanced or Metastatic Solid Tumors

Brief summary

The study will determine the recommended Phase 2 dose (RP2D) of an active drug administered as monotherapy and in combination with an active drug as well as to assess the safety, pharmacokinetics (PK), and preliminary efficacy of an active drug alone and in combination with an active drug. The study will consist of 2 phases: dose escalation and dose expansion.

Interventional study

Status:
Recruiting
Conditions:
Advanced Solid Tumors Cancer
Enrollment:
184 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M19-345
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:

- For Dose Escalation only: Subjects with an advanced solid tumor who are considered
refractory to or intolerant of all existing therapy(ies) known to provide a clinical
benefit for their condition. Additionally, subjects who have been offered standard
therapies and refused, or who are considered ineligible for standard therapies, may be
eligible for this study on a case-by-case basis, after discussion with and agreement
from the sponsor. Subjects with triple-negative breast cancer (TNBC), pancreatic
adenocarcinoma, urothelial cancer, Hepatocellular carcinoma (HCC), or Head and neck
squamous cell carcinoma (HNSCC) who are being considered for the dose escalation
cohorts must also meet the histology specific eligibility criteria described below for
dose expansion

- For Dose Expansion only subjects must meet criteria specific to the type of cancer:

- TNBC - Female or male subjects with confirmed breast adenocarcinoma that is
ER-negative, PR-negative, and HER2-negative, (as defined per American Society of
Clinical Oncology [ASCO]/College of American Pathology [CAP] guidelines), who must
have disease progression during or after at least 1 systemic therapy that included a
taxane in the metastatic or recurrent setting.

- Pancreatic adenocarcinoma and have disease progression during or after 1 systemic
therapy (gemcitabine monotherapy or in combination with other agents, FOLFIRINOX [or
another regimen including both 5-fluorouracil and oxaliplatin], capecitabine
monotherapy or in combination with other agents) administered in the adjuvant, locally
advanced, or metastatic setting. If the therapy was used in an adjuvant setting,
disease progression must have occurred within 6 months of completing adjuvant therapy.

- Urothelial cancer of the bladder and urinary tract and must have progressed following
treatment with a platinum-based regimen (administered in any line of therapy) and a
programmed death 1/programmed death ligand 1 (PD1/PDL1) antagonist administered in the
recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is
defined as unequivocal progression on or within 3 months of the last dose of anti-PD1
or anti-PDL1 therapy).

- HCC and must have disease progression during or after 1 prior line of systemic
therapy.

- HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have
progressed following treatment with platinum-based regimen (administered in any line
of therapy) and a PD1/PDL1 antagonist administered in the recurrent or metastatic
setting (progression following a PD1/PDL1 antagonist is defined as unequivocal
progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).

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

- Subject has adequate bone marrow, renal, hepatic, and coagulation function. Must have
a viral status consistent with the requirements described in the protocol specific to
type of cancer and stage of study (Dose Escalation or Dose Expansion).

Exclusion Criteria:

- For Dose Expansion only: All subjects, except for subjects with urothelial cancer or
HNSCC, must not have had prior exposure to immunotherapies as listed in the protocol.

- Has received anticancer therapy including chemotherapy, immunotherapy, radiation
therapy, biologic, herbal therapy, or any investigational therapy within a period of 5
half-lives or 28 days (whichever is shorter), prior to the first dose of the study
drug.

- Subject has no unresolved AEs > Grade 1 from prior anticancer therapy except for
alopecia.

- Has a history of primary immunodeficiency, bone marrow transplantation, solid organ
transplantation, or previous clinical diagnosis of tuberculosis.

- Has a known uncontrolled metastases to the central nervous system (with certain
exceptions).

- Current or prior use of immunosuppressive medication within 14 days prior to the first
dose of the study drug.

All the cities where the clinical studies are located

Toronto - M5G 2M9

Ontario