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

Not currently recruiting at 39 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new combination of treatments to determine their safety and effectiveness for certain solid tumors, such as triple-negative breast cancer (TNBC) and non-small-cell lung cancer (NSCLC). Researchers aim to understand how the body processes these treatments and assess their efficacy. Participants with TNBC who have tried at least one other treatment, including a taxane, or those with NSCLC who did not respond well to certain previous therapies, might be suitable for this study. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this trial have exhibited varying levels of safety in past studies.

For the combination of ABBV-927 and ABBV-368, earlier research found these treatments were generally well-tolerated, and the highest safe dose was not reached, suggesting safety at the tested doses.

In studies involving ABBV-927, ABBV-368, and ABBV-181 for non-small-cell lung cancer (NSCLC), early safety data has been shared. ABBV-181, also known as Budigalimab, has been tested in other studies and demonstrated manageable side effects across various cancer types.

When ABBV-927 is combined with Carboplatin for triple-negative breast cancer (TNBC), long-term safety data for Carboplatin indicates it is generally safe, as it is widely used in cancer treatments.

Adding Nab-paclitaxel to ABBV-927 and ABBV-368 in TNBC has also shown acceptable safety in past research, with Nab-paclitaxel being a common chemotherapy drug for breast cancer.

Since this trial is in its early phase, it primarily focuses on determining the safety and optimal dosing of these treatments. While early data appears promising, complete safety profiles are still being developed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they bring a novel approach to tackling tough cancers like Triple Negative Breast Cancer (TNBC) and Non-Small Cell Lung Cancer (NSCLC). Unlike traditional chemotherapy, which broadly attacks rapidly dividing cells, these investigational treatments combine targeted therapies such as ABBV-181 and ABBV-368 with chemotherapy agents like carboplatin and nab-paclitaxel. ABBV-181 and ABBV-368 are designed to enhance the immune system’s ability to fight cancer by potentially boosting the body's own defenses. This combination strategy aims to increase the precision and effectiveness of treatment, offering hope for better outcomes in cancers that are often resistant to standard therapies.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Earlier studies have shown that combining ABBV-927 and ABBV-368 helps the immune system attack cancer cells. In this trial, participants in different arms will receive various combinations of these drugs to see if they can enhance the body's defense against solid tumors. For instance, one arm will test ABBV-927 with Carboplatin, as past research on similar combinations has indicated a decrease in cancer progression risk, offering hope for treating certain cancers like triple-negative breast cancer (TNBC). Another arm will test Nab-paclitaxel with ABBV-927 and ABBV-368, as Nab-paclitaxel has proven effective in treating metastatic breast cancer. Additionally, the combination of ABBV-927, ABBV-368, and ABBV-181 is being tested in another arm, as early studies of a similar mix showed encouraging results in fighting certain lung cancers by blocking proteins that allow cancer cells to evade the immune system. This trial studies these combinations to determine if they can successfully combat difficult-to-treat cancers by enhancing the body's natural defenses. ^{1 4 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03893955

NCT03893955 | A Study to Determine the Safety, ... 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 ...

2. clinicaltrial.be clinicaltrial.be/en/details/64514?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

A Study to Determine the Safety, Tolerability, Pharmacoki... A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV- ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.TPS3147

A phase I study of CD40 agonist ABBV-927 plus OX40 ... This open-label, Phase 1 study will evaluate the doublet combination of ABBV-927 and ABBV-368 and the triplet combination of ABBV-927, ABBV-368, and the ...

4. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M19-037

M19-037 A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03893955?cond=small+cell+lung+cancer&aggFilters=status%3A

A Study to Determine the Safety, Tolerability, Pharmacokinetics, ... A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03893955?cond=Non+Small+Cell+Lung+Cancer

A Study to Determine the Safety, Tolerability, ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8783908/

First-in-human phase 1 study of budigalimab, an anti-PD-1 ... We present the safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data from patients enrolled in the head and neck squamous cell carcinoma (HNSCC) and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419594996

Safety and efficacy of anti-PD-1 inhibitor ABBV-181 in lung ... ABBV-181 is a humanized anti-PD1 monoclonal antibody; dose finding and early safety, PK and pharmacodynamic data have been reported (ESMO18).