ABBV-514 for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Providence Medical Foundation /ID# 247453, Fullerton, CA
Lung Cancer+6 More
ABBV-514 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called ABBV-514 can be safely given to people with cancer.

See full description

Eligible Conditions

  • Lung Cancer
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether ABBV-514 will improve 7 primary outcomes in patients with Lung Cancer. Measurement will happen over the course of Up to 2 Years.

Up to 2 Years
Antidrug Antibody (ADA)
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514
Maximum Observed Serum Concentration (Cmax) of ABBV-514
Neutralizing Antidrug Antibody (ADA)
Number of Participants with Adverse Events (AE)
Terminal Elimination Half-Life (t1/2) of ABBV-514
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

5 Treatment Groups

Part 1 Dose Escalation: ABBV-514 + Pembrolizumab
1 of 5
Part 1 Dose Escalation: ABBV-514
1 of 5
Part 2 Dose Expansion: ABBV-514 + Pembrolizumab
1 of 5
Part 2 Dose Expansion: ABBV-514 + Budigalimab
1 of 5
Part 2 Dose Expansion: ABBV-514
1 of 5
Experimental Treatment

This trial requires 136 total participants across 5 different treatment groups

This trial involves 5 different treatments. ABBV-514 is the primary treatment being studied. Participants will be divided into 5 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.

Part 1 Dose Escalation: ABBV-514 + PembrolizumabParticipants will receive ABBV-514 in combination with pembrolizumab.
Part 1 Dose Escalation: ABBV-514
Drug
Participants will receive ABBV-514.
Part 2 Dose Expansion: ABBV-514 + PembrolizumabParticipants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with pembrolizumab
Part 2 Dose Expansion: ABBV-514 + BudigalimabParticipants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Part 2 Dose Expansion: ABBV-514
Drug
Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Providence Medical Foundation /ID# 247453 - Fullerton, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lung Cancer or one of the other 6 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
-- Must have an advanced solid tumor who are considered refractory to or intolerant of all existing therapies known to provide a clinical benefit for their condition.
Must have histologically or cytologically confirmed advanced or metastatic NSCLC or HNSCC that has been treated with platinum-based chemotherapy and a programmed cell death (PD)-1 or PD ligand 1 (PD-L1) targeting agent (separately or in combination therapy).
Must have failed (or refused) treatment with available therapies known to be active for treatment of their disease.
Participants enrolled in dose escalation must have disease that is evaluable or measurable per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1).
Participants enrolled in dose expansion must have measurable disease per RECIST, version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Laboratory values meeting the criteria outlined in the protocol.

Patient Q&A Section

Does abbv-514 improve quality of life for those with oral squamous cell carcinoma?

"Abbv-514 improved the quality of life of patients with advanced oral cancers, compared with standard care alone. This effect was independent of age, gender, and performance status." - Anonymous Online Contributor

Unverified Answer

How many people get oral squamous cell carcinoma a year in the United States?

"Oral SCC was seen in approximately 1 in 97,000 adults per year in the United States during 1996–1995. These rates were slightly higher among men at 1 in 107, and lower among African Americans at 1 in 111. Although the overall incidence of oral SCC increased from 1980 to 1995, there was no significant increase in the number of new cases of oral SCC detected annually during this time period. The reason for this disparity between incidence and detection remains unclear." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for oral squamous cell carcinoma?

"Recent findings show that patients have a positive attitude towards clinical trials. Patient's willingness to participate can depend on how they perceive risks related to clinical trials. The main reasons why patients would not want to participate were lack of information about clinical trials, misunderstandings regarding their purpose, and emotional distress related to risk perception. As a result, and considering our findings, we think that patients' attitudes toward clinical trials are good." - Anonymous Online Contributor

Unverified Answer

Can oral squamous cell carcinoma be cured?

"Oral SCC are highly metastatic tumors. With current therapies, ~40% of patients with advanced disease achieve complete remission. curative resection may improve survival but does not prevent recurrence. It is important to recognize when curative surgery may offer the best chance of long-term survival and to continue these patients on postoperative surveillance so that early detection and intervention can minimize the morbidity and mortality associated with SCC." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving abbv-514?

"There are no additional ABBV-514 trial enrollments underway at any time. The Phase I and II studies were completed successfully. Findings from a recent study of these studies will be reported soon.\n" - Anonymous Online Contributor

Unverified Answer

What is abbv-514?

"ABBV-514 is an immunostimulatory peptide that promotes CD8+ T-cell responses against O-glycan antigens expressed on human leukemia and gut tumors. This peptide also appears to induce greater tumor regression when given following initial chemotherapy than after subsequent surgery." - Anonymous Online Contributor

Unverified Answer

What are common treatments for oral squamous cell carcinoma?

"The most commonly used treatments for oral squamous cell carcinoma were surgery (63%), radiation therapy (33%), and combined chemotherapy (3%). Because of the wide range of treatments for oral squamous cell carcinoma, it is important that patients receive all the information they need to make an informed decision about their treatment options." - Anonymous Online Contributor

Unverified Answer

What does abbv-514 usually treat?

"Abbv-514 has shown some activity in treating oral squamous cell carcinomas. The mechanism of action of the drug seems to be inhibition of telomerase activity. Further studies are needed to explore whether this effect is related to abbv-514's anticancer activities." - Anonymous Online Contributor

Unverified Answer

What is the latest research for oral squamous cell carcinoma?

"Results from large multi-institutional studies indicate that there is no improvement over previous data in terms of overall survival and disease-free survival for OSCC patients treated with concurrent chemoradiotherapy (CRT). In addition, the quality of life remains poor. However, improvements in local control were seen in select subgroups of patients, especially those who received CRT alone." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets oral squamous cell carcinoma?

"Oral cancer occurs more frequently in men than women at all ages. The mean age at diagnosis for OSCC was 70 years, with a range of 51 years to 94 years. In a recent study, the average age of presentation of OSCC was 73 years. Findings from a recent study provides additional evidence that smoking increases the risk of developing oral cancer." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for oral squamous cell carcinoma?

"The 5-year survival rate for patients diagnosed with oral cancer was 58%. The strongest predictors of outcome were patient age and socioeconomic status. Patients who had undergone radiotherapy received a significantly better survival outcome than those who did not." - Anonymous Online Contributor

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