ABBV-927 + ABBV-181 + Nab-paclitaxel + ABBV-368 + Carboplatin for Solid Tumors

Recruiting at 32 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Corticosteroids

Disqualifiers: Inflammatory bowel disease, Pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing new drugs combined with chemotherapy to treat patients with certain types of solid tumors. It aims to understand how these treatments work together and their safety.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for adults with certain advanced solid tumors, including specific types of breast and lung cancer. Participants must have adequate organ function and an ECOG performance status of 0 or 1. They should not have received certain prior treatments depending on their cancer type, and cannot join if they have uncontrolled brain metastases, recent major surgery, severe reactions to immune therapies, inflammatory bowel disease/pneumonitis, or other significant concurrent cancers.

Inclusion Criteria

Adequate liver, kidney and hematology function as demonstrated by laboratory values detailed in the study protocol.

Participants with histologically or cytologically confirmed TNBC who have received no previous anti-cancer therapy for TNBC, and who are PD-L1 negative on tumor tissue by immunohistochemistry (IHC) assay.

An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

Has uncontrolled metastases to the central nervous system.

Has had a major surgery ≤ 28 days prior to the first dose of study drug or the surgical wound is not fully healed.

Has previously treated with an anti-PD- or PD-L1-targeting agent and had during the course of their therapy: any immune-mediated toxicity of Grade 3 or worse severity, treatment of the toxicity with systemic corticosteroids, any hypersensitivity to the PD-1 or PD-L1-targeting agent, any treatment-related toxicity resulting in discontinuation of the PD-1 or PD-L1 targeting agent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Participants receive various doses of ABBV-927 with ABBV-368 and/or ABBV-181 to determine the recommended phase 2 dose (RP2D)

Up to approximately 6 months

Dose-Expansion

Participants receive the study drug at the RP2D to evaluate safety, pharmacokinetics, and preliminary efficacy

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 12 weeks

Treatment Details

Interventions

• ABBV-181
• ABBV-368
• ABBV-927
• Carboplatin
• Nab-paclitaxel

Trial Overview The study tests the safety and early effectiveness of ABBV-927 combined with ABBV-368, Budigalimab (ABBV-181), and/or chemotherapy in patients with selected solid tumors. It includes a dose-finding phase followed by a phase where more people receive the best dose found to be safe.

Participant Groups

Group I: Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC Experimental Treatment 3 Interventions

Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.

Group II: Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC Experimental Treatment 3 Interventions

Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.

Group III: Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC Experimental Treatment 2 Interventions

Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.

Group IV: Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC Experimental Treatment 3 Interventions

Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.

Group V: Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC Experimental Treatment 3 Interventions

Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.

Group VI: Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC Experimental Treatment 3 Interventions

Participants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181.

Group VII: Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors Experimental Treatment 2 Interventions

Participants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois