A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors

AbbVie

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Paclitaxel; Drug: Docetaxel; Drug: ABBV-155

Study type: Interventional

Funder types: Industry

Identifiers

NCT03595059

2020-002495-12 (EudraCT Number)

M16-573

Details and patient eligibility

About

An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone and in combination with paclitaxel or docetaxel.

In Part 1 (dose escalation), participants will receive escalating doses of ABBV-155 monotherapy (Part 1a) or ABBV-155 in combination with paclitaxel or docetaxel (Part 1b).

In Part 2 (dose expansion), participants will receive ABBV-155 monotherapy or in combination therapy. The ABBV-155 monotherapy cohort will enroll participants with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the ABBV-155 plus a taxane (paclitaxel or docetaxel) combination cohort will enroll participants with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b).

Full description

The Escalation cohorts (Part 1) have been completed. The expansion cohorts (Part 2) are open to enrollment.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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) diagnosis; participants enrolled to Part 2b (combination therapy, dose expansion) must have either NSCLC or HR-positive/HER2-negative breast cancer.

• 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) including the safety lead-in phase (Japan only).

• 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. Participants with activating mutations in EGFR, ALK/ROS1, BRAF genes, or with positive expression of PD-L1 must have been treated with the appropriate targeted therapies.

• 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 if exposed to prior taxane-based therapy:

  • No history of taxane allergy (Part 1b and Part 2b only).
  • 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.
• Any history of hypersensitivity to any ingredients of ABBV-155 will be excluded. For combination therapy only (Parts 1b and 2b), no history of serious allergic reaction to any taxane or any ingredients used in taxane formulation (e.g., cremaphor).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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169 participants in 5 patient groups

Escalation 1a: ABBV-155

Experimental group

Description:

Participants will be administered ABBV-155 (various doses).

Treatment:

Drug: ABBV-155

Escalation 1b: ABBV-155 + paclitaxel or docetaxel

Experimental group

Description:

Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .

Treatment:

Drug: ABBV-155

Drug: Docetaxel

Drug: Paclitaxel

Expansion 2a: ABBV-155 in SCLC

Experimental group

Description:

Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).

Treatment:

Drug: ABBV-155

Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer

Experimental group

Description:

Participants with breast cancer will be administered ABBV-155 (at the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with paclitaxel.

Treatment:

Drug: ABBV-155

Drug: Paclitaxel

Expansion 2b: ABBV-155 + docetaxel in NSCLC

Experimental group

Description:

Participants with non-small cell lung cancer (NSCLC) will be administered ABBV-155 (at or near the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with docetaxel.

Treatment:

Drug: ABBV-155

Drug: Docetaxel