NL-OMON55246RecruitingNot Applicable
A Phase 1 First-in-Human Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Tumors - M16-573
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Has a histologic or cytologic diagnosis of a malignant solid tumor.
- •Subjects enrolled in Part 2a (monotherapy, dose expansion) must have SCLC
- •Subjects enrolled to Part 2b (combination therapy, dose expansion) must have
- •either NSCLC or HR-positive/HER2-negative breast cancer. For Part 2, sponsor
- •may elect (at its discretion) to prospectively screen for subjects whose tumor
- •express B7H3 based on central IHC assessment of fresh or archival tumor tissue.
- •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 subjects in the dose-escalation phase (Parts 1a and 1b).
- •All subjects 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 cyclindependent 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 subjects with non-small cell lung cancer (NSCLC) for subjects in the
- •dose-expansion phase (Part 2b only) must have R/R NSCLC after at least 1 line
- •of therapy.
- •All subjects 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-L1/PD-1 therapy.
- •All subjects with either breast cancer or NSCLC must have the following if
- •exposed to prior taxane-based therapy:
- •-no history of taxane allergy (Parts 1b and 2b only)
- •-disease that has relapsed or progressed at least 2 months after initiation
- •of the most recent taxane-based therapy.
- •Available tumor tissue suitable for immunohistochemistry testing.
- •Adequate kidney, liver, and hematologic laboratory values as described in the
Exclusion Criteria
- •No untreated brain or meningeal metastases (i.e., subjects with history of
- •metastases are eligible provided they do not require ongoing steroid treatment
- •and have shown clinical and radiographic stability for at least 28 days after
- •definitive therapy.
- •Grade 2 or higher peripheral neuropathy (only applies to subjects 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), history of serious
- •allergic reaction to any taxane or any ingredients used in taxane formulation.
Investigators
Similar Trials
Completed
Phase 1
A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid TumorsJPRN-jRCT2080225314AbbVie G.K.27
Completed
Phase 1
A Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Solid Tumors2024-513625-23-00AbbVie Deutschland GmbH & Co. KG168
Active, not recruiting
Phase 1
[M17-327] A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung CancerRelapsed or Refractory Small Cell Lung CancerJPRN-jRCT2051200161Yajima Yoko188
Completed
Phase 1
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants.Healthy VolunteersNCT06414798AbbVie60
Completed
Phase 1
First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic TumorsAdvanced Solid Tumors CancerNCT04417465Calico Life Sciences LLC101