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
Overview
- Phase
- Phase 1
- Intervention
- ABBV-155
- Conditions
- Not specified
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Enrollment
- 168
- Locations
- 40
- Primary Endpoint
- Overall Response Rate (ORR)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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).
Detailed Description
The Escalation cohorts (Part 1) have been completed. The expansion cohorts (Part 2) are open to enrollment.
Investigators
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Escalation 1a: ABBV-155
Participants will be administered ABBV-155 (various doses).
Intervention: ABBV-155
Escalation 1b: ABBV-155 + paclitaxel or docetaxel
Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .
Intervention: ABBV-155
Escalation 1b: ABBV-155 + paclitaxel or docetaxel
Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .
Intervention: Paclitaxel
Escalation 1b: ABBV-155 + paclitaxel or docetaxel
Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .
Intervention: Docetaxel
Expansion 2a: ABBV-155 in SCLC
Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).
Intervention: ABBV-155
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.
Intervention: ABBV-155
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.
Intervention: Paclitaxel
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.
Intervention: ABBV-155
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.
Intervention: Docetaxel
Outcomes
Primary Outcomes
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.
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).
Secondary Outcomes
- Tmax of ABBV-155(Up to approximately 48 days)
- Progression-Free Survival (PFS)(Up to approximately 12 months)
- Number of Participants with Adverse Events (AE)(Up to approximately 12 months)
- Duration of Response (DOR)(Up to approximately 12 months)
- Rate of Complete Response (CR)(Up to approximately 2 to 6 months)
- Terminal Phase Elimination Rate constant of ABBV-155(Up to approximately 48 days)
- QTcF Change from Baseline(Up to approximately 8 days)
- Cmax of ABBV-155(Up to approximately 48 days)
- Overall Survival (OS)(Up to approximately 12 months after last dose of study drug)
- AUCt of ABBV-155(Up to approximately 48 days)
- AUCinf of ABBV-155(Up to approximately 48 days)
- t1/2 of ABBV-155(Up to approximately 48 days)