A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
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| ClinicalTrials.gov Identifier: NCT03595059 |
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Recruitment Status :
Active, not recruiting
First Posted : July 23, 2018
Last Update Posted : May 18, 2023
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
- Study Details
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Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Solid Tumors | Drug: ABBV-155 Drug: Paclitaxel Drug: Docetaxel | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 169 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | July 13, 2018 |
| Estimated Primary Completion Date : | November 1, 2023 |
| Estimated Study Completion Date : | November 1, 2023 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Docetaxel
| Arm | Intervention/treatment |
|---|---|
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Experimental: Escalation 1a: ABBV-155
Participants will be administered ABBV-155 (various doses).
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Drug: ABBV-155
Intravenous (IV) Infusion |
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Experimental: Escalation 1b: ABBV-155 + paclitaxel or docetaxel
Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .
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Drug: ABBV-155
Intravenous (IV) Infusion Drug: Paclitaxel Intravenous (IV) Infusion Drug: Docetaxel Intravenous (IV) Infusion |
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Experimental: Expansion 2a: ABBV-155 in SCLC
Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).
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Drug: ABBV-155
Intravenous (IV) Infusion |
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Experimental: Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer
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.
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Drug: ABBV-155
Intravenous (IV) Infusion Drug: Paclitaxel Intravenous (IV) Infusion |
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Experimental: Expansion 2b: ABBV-155 + docetaxel in NSCLC
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.
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Drug: ABBV-155
Intravenous (IV) Infusion Drug: Docetaxel Intravenous (IV) Infusion |
Primary Outcome Measures :
- MTD and/or RPTD of ABBV-155 [ Time Frame: Up to approximately 21 days after initial dose of study drug ]The Maximum Tolerated Dose (MTD) and/or the Recommended Phase Two Dose (RPTD) of ABBV-155 will be determined during the dose escalation phase (Part 1).
- Overall Response Rate (ORR) [ Time Frame: Up to approximately 2 to 6 months ]ORR is defined as the percentage of participants with documented best response partial response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Secondary Outcome Measures :
- Number of Participants with Adverse Events (AE) [ Time Frame: Up to approximately 12 months ]An AE is defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
- Duration of Response (DOR) [ Time Frame: Up to approximately 12 months ]DOR is defined as the number of days from the date of first documented response (PR or better) to the date of the first documented disease progression (PD) or death due to disease, whichever occurs first.
- Rate of Complete Response (CR) [ Time Frame: Up to approximately 2 to 6 months ]CR is defined as the percentage of participants with documented best response CR according to RECIST version 1.1
- Progression-Free Survival (PFS) [ Time Frame: Up to approximately 12 months ]PFS is defined as the number of days from the date of first dose of study drug to the date of the first documented PD or death due to any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Up to approximately 12 months after last dose of study drug ]OS is defined as the number of days from the date of first study drug to the date of death due to any cause.
- Cmax of ABBV-155 [ Time Frame: Up to approximately 48 days ]Maximum plasma concentration (Cmax).
- Tmax of ABBV-155 [ Time Frame: Up to approximately 48 days ]Time to maximum plasma concentration (Tmax).
- Terminal Phase Elimination Rate constant of ABBV-155 [ Time Frame: Up to approximately 48 days ]Terminal phase elimination rate constant of ABBV-155
- AUCt of ABBV-155 [ Time Frame: Up to approximately 48 days ]Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt).
- AUCinf of ABBV-155 [ Time Frame: Up to approximately 48 days ]AUC from time 0 to infinite time (AUCinf).
- QTcF Change from Baseline [ Time Frame: Up to approximately 8 days ]QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level of ABBV-155 Monotherapy.
- t1/2 of ABBV-155 [ Time Frame: Up to approximately 48 days ]Terminal elimination half-life (t1/2).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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) 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).
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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.
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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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595059
Locations
Show 40 study locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03595059 |
| Other Study ID Numbers: |
M16-573 |
| First Posted: | July 23, 2018 Key Record Dates |
| Last Update Posted: | May 18, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by AbbVie:
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Cancer Advanced Solid Tumors Relapsed and/or Refractory Solid Tumors ABBV-155 Taxane |
Paclitaxel Docetaxel breast cancer non-small cell lung cancer (NSCLC) small cell lung cancer (SCLC) |
Additional relevant MeSH terms:
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Neoplasms Paclitaxel Docetaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |