NCT03595059

A Study With an Active Drug Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors

Brief summary

An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of an active drug alone and in combination with paclitaxel or docetaxel.

In Part 1 (dose escalation), subjects will receive escalating doses of an active drug monotherapy (Part 1a) or an active drug in combination with paclitaxel or docetaxel (Part 1b).

In Part 2 (dose expansion), subjects will receive an active drug monotherapy or in combination therapy. The active drug monotherapy cohort will enroll subjects with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the active drug plus a taxane (paclitaxel or docetaxel) combination cohort will enroll subjects with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b).

Interventional study

Status:
Recruiting
Conditions:
Advanced Solid Tumors
Enrollment:
176 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-573
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:

- Has a histologic or cytologic diagnosis of a malignant solid tumor.

- Participants enrolled in Part 2a (monotherapy, dose expansion) must have small cell
lung cancer (SCLC) with tumors that express B7H3 above a given threshold per central
laboratory testing; participants enrolled to Part 2b (combination therapy, dose
expansion) must have either NSCLC or HR-positive/HER2-negative breast cancer with
tumors that express B7H3 above a given threshold per central laboratory testing.

- Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST)
criteria.

- An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
2.

- Failure of at least 1 prior systemic chemotherapy including all available standard
therapies for participants in the dose-escalation phase (Parts 1a and 1b).

- All participants with breast cancer for subjects in the dose-expansion phase (Part 2b
only) must have the following:

- locally advanced or metastatic HR-positive/HER2-negative breast cancer after
failing cyclin-dependent kinase (CDK)4/6 inhibitor-based therapy.

- HR-positivity and HER-2-negativity should be confirmed based on American Society
of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria.

- All participants with non-small cell lung cancer (NSCLC) for participants in the
dose-expansion phase (Part 2b only) must have R/R NSCLC after at least 1 line of
therapy.

- All participants with SCLC in the dose-expansion phase (Part 2a only) must have R/R
SCLC from at least 1 line of therapy which includes a platinum-based therapy with or
without an anti-PD-1/PD-L1 therapy.

- All participants with either breast cancer or NSCLC must have the following: exposure
to prior taxane-based therapy; no history of taxane allergy (Part 1b and Part 2b
only); and disease that has relapsed or progressed at least 2 months after most recent
exposure to any taxane-based therapy.

- Available tumor tissue suitable for immunohistochemistry testing.

- Adequate kidney, liver, and hematologic laboratory values as described in the
protocol.

Exclusion Criteria:

- Untreated brain or meningeal metastases (participants with a history of metastases may
be eligible based on details described in the protocol).

- Grade 2 or higher peripheral neuropathy (only applies to participants who would
receive taxane therapy).

- Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except
alopecia.

- Known active infection of hepatitis B, hepatitis C, or human immunodeficiency virus
with exceptions as described in the protocol.

- Recent history (within 6 months) of congestive heart failure (defined in the
protocol), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological
or surgical intervention, pericardial effusion, or pericarditis.

- For combination therapy only (Parts 1b and 2b), history of serious allergic reaction
to any taxane or any ingredients used in taxane formulation.

All the cities where the clinical studies are located

Edmonton - T6G 1Z2

Toronto - M5G 2M9

Alberta

Ontario