ABBV-151 for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Hospital Clinic de Barcelona /ID# 221106, Barcelona, Spain
Cancer+1 More
ABBV-151 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a drug may help treat Crohn's disease.

See full description

Eligible Conditions

  • Cancer
  • Neoplasms
  • Advanced Cancers (Solid Tumors)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether ABBV-151 will improve 3 primary outcomes and 17 secondary outcomes in patients with Cancer. Measurement will happen over the course of Up to approximately 9 months after the first dose date of last participant.

Day 28
Dose Escalation: RP2D ABBV-151 + Budigalimab Combination Therapy
Day 28
Dose Escalation: Recommended Phase 2 Dose (RP2D) ABBV-151 Monotherapy
Month 6
Change in Electrocardiogram (ECG)
Change in Laboratory Parameters
Change in Vital Signs
Incidence of Anti-drug Antibody (ADA)
Month 6
Dose Expansion: Duration of Response (DOR)
Dose Expansion: Objective Response Rate (ORR)
Dose Expansion: Progression-free Survival (PFS)
Day 70
Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of ABBV-151
Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Budigalimab
Maximum Observed Serum Concentration (Cmax) of ABBV-151
Maximum Observed Serum Concentration (Cmax) of Budigalimab
Terminal Phase Elimination Half-life (t1/2) of ABBV-151
Terminal Phase Elimination Half-life (t1/2) of Budigalimab
Terminal-phase Elimination Rate Constant (β) of ABBV-151
Terminal-phase Elimination Rate Constant (β) of Budigalimab
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-151
Time to Maximum Observed Serum Concentration (Tmax) of Budigalimab
Month 9
Number of Participants With Adverse Events (AEs)

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
ABBV-151 Monotherapy

This trial requires 260 total participants across 2 different treatment groups

This trial involves 2 different treatments. ABBV-151 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

ABBV-151 Monotherapy
Drug
Various doses of ABBV-151 administered during dose escalation, followed by dose expansion of ABBV-151 administered at the Recommended Phase 2 Dose (RP2D).
ABBV-151 + Budigalimab Combination TherapyVarious doses of ABBV-151 plus budigalimab Dose A administered every 4 weeks (Q4W) during dose escalation, followed by dose expansion of ABBV-151 administered at the RP2D plus budigalimab Dose A administered Q4W.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 28 days after the first dose of abbv-151 and abbv-181 combination therapy
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 28 days after the first dose of abbv-151 and abbv-181 combination therapy for reporting.

Closest Location

AdventHealth Celebration /ID# 224860 - Kissimmee, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
CRC participants with microsatellite stable or mismatch repair proficient colorectal adenocarcinoma who have received 1-2 prior chemotherapy regimens and who have refused or are ineligible for other therapies approved by the FDA. show original
The participant has no abnormalities in their bone marrow, kidneys, liver, or clotting system. show original
The virus must meet the requirements set out in the specific protocol for the type of cancer and stage of the study. show original
Patients with advanced head and neck cancer that has recurred or spread following treatment with platinum-based chemotherapy, and who are treated with a PD1 or PDL1 inhibitor drug, can be eligible for this study. show original
Patients with pancreatic cancer who have disease progression during or after receiving one systemic therapy (gemcitabine monotherapy or in combination with other agents, FOLFIRINOX [or another regimen including both 5-fluorouracil and oxaliplatin], capecitabine monotherapy or in combination with other agents) administered in the adjuvant, locally advanced, or metastatic setting are eligible for this study show original
This policy applies to patients with urothelial cancer of the bladder and urinary tract that has progressed following treatment with platinum-based chemotherapy and a programmed death 1 (PD1) inhibitor or programmed death ligand 1 (PDL1) inhibitor, administered in any line of therapy, in the recurrent or metastatic setting show original
The participant has a very good prognosis and a low chance of complications. show original
For Dose Escalation only: Participants with an advanced solid tumor who are considered refractory to or intolerant of all existing therapy(ies) known to provide a clinical benefit for their condition. Additionally, participants who have been offered standard therapies and refused, or who are considered ineligible for standard therapies, may be eligible for this study on a case-by-case basis, after discussion with and agreement from the sponsor. Participants with triple-negative breast cancer (TNBC), pancreatic adenocarcinoma, urothelial cancer, Hepatocellular carcinoma (HCC), or Head and neck squamous cell carcinoma (HNSCC) who are being considered for the dose escalation cohorts must also meet the histology specific eligibility criteria described below for dose expansion
People with breast cancer who do not have the estrogen or progesterone receptors (ER or PR) and who also do not have too much of the HER2 protein on their cancer cells (HER2-negative) may be eligible to take part in this study show original
HCC patients must have disease progression during or after one prior line of systemic therapy. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get cancer a year in the United States?

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As with prevalence of most diseases, the age-adjusted incidence of cancer has increased in U.S. men over the last 40 years. Incidence of colorectal cancer has increased more than any other. Incidence of breast cancer has increased faster than any other.

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What are the signs of cancer?

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Signs of cancer can often be present at an early stage, and include fatigue, loss of appetite, bleeding from the vagina. If a female has a lump in her breast, her mother's menstrual periods may be irregular, or her skin may itch.

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What causes cancer?

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Cancer is caused by a combination of the environment (infection, smoking) that lead to carcinogenesis and by somatic mutations that alter gene function. Genetic factors play a role in cancer.

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What is cancer?

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Cancer is not a single disease entity: it is a group of diseases that are often difficult to differentiate and that are difficult to treat. The treatment of the disease depends on many factors, and a multidisciplinary approach is essential.

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What are common treatments for cancer?

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The most common treatment for cancer is surgery. Radiation therapy and chemotherapy, such as the anti-cancer drug Cisplatin, are also quite common. Lastly, several of cancer's major symptoms, such as constipation and headache, are also common symptom treatments for cancer.\n

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Can cancer be cured?

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There is no evidence for this "can't cure" phenomenon. The idea has been refuted and debunked for decades but it still can fool people with its appealing words. The notion of curable cancer is also disputed here.

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Have there been other clinical trials involving abbv-151?

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Abbv150 has been shown to have profound anti-tumor, angiogenesis, and anti-metastasis activities. It is also effective for the treatment of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) and glioma. Further studies are warranted to explore this new drug in other cancers, particularly breast, lung, esophageal, pancreatic, and ovarian cancers.

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Does cancer run in families?

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Most families with at least one case, a family history of breast or [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer) are multiple cases and are on the same side of the family on the same side of the family. This is interesting because most multiple cancer cases in our families are clustered in one case family. So there is always a close relationship between an individual's family cancer histories. The same relationship that is seen in most families with cancer that most of them are multiple with each other. All these families can be classified as all multiple primary cancer families that are in close relation because all of them have cancers diagnosed in multiple families or in the same family.

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What is the average age someone gets cancer?

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Median age people had cancer was 65.6 years, which is consistent with the average life expectancy and expected incidence rates, which suggests that while cancer prevalence is on the increase, its incidence is decreasing, and this can be attributed to improved early detection by cancer screening initiatives, improved disease outcomes by disease-modifying and aggressive therapies, and changes in demographics. Therefore, although cancer incidence and prevalence is on the rise, the average age at which people receive cancer remains relatively stable.

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Who should consider clinical trials for cancer?

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Participation was more common among patients who had a family member with cancer. Physicians who recommend clinical trials usually report good experiences (e.g., benefits in survival). Clinicians should emphasize the potential benefits of clinical trials, and consider patients' preferences, before recommending trials in clinical practice.

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What are the common side effects of abbv-151?

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One of the common side effects is nausea, which occurs in 21.4%-22.4% of subjects treated on abbv-151, compared to 7.7% in the placebo group. The most common reported side effects, of any number of severity, were fatigue, abdominal pain, and headache, occurring most commonly in subjects treated with abbv-151. There were no significant changes in liver function tests or serum lipid levels.

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How does abbv-151 work?

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Since there is an absence of an active site of Abbv-151, its interaction with cells is thought to be non-specific. The low-molecular-weight compounds Abbv-151 and abbv-152, may exert their chemotherapeutic action through a cascade of indirect cell damage. The presence of free radicals produced at the cellular level is the underlying mechanism for this cascade of events. Further in situ and in vivo studies can now prove these hypotheses.

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