Clinical Trials List
Protocol NumberM16-573
NCT Number(ClinicalTrials.gov Identfier)NCT03595059
Completed
2019-01-08 - 2020-09-30
Phase I
Not yet recruiting2
Recruiting1
A Phase 1 First-in-Human Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ming-Hung Tsai 無
- Chen-Yuan Lin 無
- Tzu-Ting Chen 無
- Ming-Yu Lien 無
- Yu-Min Liao 無
- Ching Yun Hsieh Division of Hematology & Oncology
- Yao-Chung Wu 無
- Su-Peng Yeh 無
- Li-Yuan Bai 無
- Chi-Ching Chen 無
- Ching-Chan Lin 無
- Che-Hung Lin 無
- Liang-Chih Liu 無
- Chih-Yen Tu 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 廖斌志 Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- 蔡子修 Division of General Internal Medicine
- 張端瑩 Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
- 廖唯昱 Division of Hematology & Oncology
- YEN-SHEN LU Division of Hematology & Oncology
- 陳怡君 Division of Hematology & Oncology
- Jih-Hsiang Lee Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- Wei-Wu Chen Division of Hematology & Oncology
- James Chih-Hsin Yang Division of Hematology & Oncology
- Chong-Jen Yu Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- 林季宏 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Audit
None
Co-Principal Investigator
- Wen-Pin Su Division of General Internal Medicine
- Jui-Hung Tsai Division of General Internal Medicine
- Shang-Yin Wu Division of General Internal Medicine
- Po-Lan Su 無
- Yu-Min Yeh Division of General Internal Medicine
- Chia-Jui Yen Division of General Internal Medicine
- Wei-Pang Chung Division of General Internal Medicine
- Chien-Chung Lin 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Condition/Disease
Relapsed and/or Refractory Solid Tumors
Objectives
Primary
To determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RPTD) of
ABBV-155 administered as monotherapy (Part 1a)
To determine MTD and RPTD of ABBV-155 administered in combination with paclitaxel or
docetaxel (Part 1b)
To evaluate the overall response rate (ORR) of ABBV-155 among subjects with R/R SCLC whose
tumors express B7H3 (Part 2a)
To evaluate the ORR of ABBV-155 in combination with paclitaxel in subjects with R/R breast
cancer and in combination with docetaxel in subjects with R/R NSCLC whose tumors express
B7H3 (Part 2b)
Test Drug
ABBV-155
Active Ingredient
ABBV-155
Dosage Form
injection
Dosage
100 mg
Endpoints
Efficacy endpoints will include:
objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST),
version 1.1
duration of response (DOR)
rate of complete response (CR)
progression-free survival (PFS)
overall survival (OS) at 12 months
objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST),
version 1.1
duration of response (DOR)
rate of complete response (CR)
progression-free survival (PFS)
overall survival (OS) at 12 months
Inclution Criteria
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 if exposed 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.
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 if exposed 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
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).
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).
The Estimated Number of Participants
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Taiwan
5 participants
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Global
125 participants
