ABBV-400 for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hadassah Medical Center /ID# 243821, Jerusalem, Israel
Lung Cancer+5 More
ABBV-400 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug called ABBV-400 can be given to people with advanced lung cancer.

See full description

Eligible Conditions

  • Lung Cancer
  • Gastro-oesophageal Adenocarcinoma
  • Solid Tumors, Advanced Solid Tumors
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lung Cancer

Study Objectives

This trial is evaluating whether ABBV-400 will improve 1 primary outcome and 3 secondary outcomes in patients with Lung Cancer. Measurement will happen over the course of Up to 24 Months.

Up to 24 Months
Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1
Overall survival (OS)
PFS per RECIST v1.1
Up to Month 24
Change it to Objective Response Rate (ORR)

Trial Safety

Safety Progress

1 of 3

Other trials for Lung Cancer

Trial Design

7 Treatment Groups

Part 2d (Squamous NSCLC)
1 of 7
Part 2c (wtEGFR NSCLC)
1 of 7
Part 3 (Gastric/Gastroesophageal Junction Adenocarcinoma)
1 of 7
Part 2b (mutEGFR NSCLC)
1 of 7
Part 2a (wtEGFR Non-Small Cell Lung Cancer [NSCLC])
1 of 7
Part 1 (Monotherapy Dose Escalation)
1 of 7
Part 2a (wtEGFR NSCLC)
1 of 7
Experimental Treatment

This trial requires 190 total participants across 7 different treatment groups

This trial involves 7 different treatments. ABBV-400 is the primary treatment being studied. Participants will be divided into 7 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 2d (Squamous NSCLC)
Drug
Participants with squamous NSCLC will receive ABBV-400 at RP2D.
Part 2c (wtEGFR NSCLC)
Drug
Participants with c-Met low non-squamous wtEGFR NSCLC will receive ABBV-400 at RP2D.
Part 3 (Gastric/Gastroesophageal Junction Adenocarcinoma)
Drug
Participants with c-Met overexpressing Gastroesophageal adenocarcinoma will receive ABBV-400 at the RP2D.
Part 2b (mutEGFR NSCLC)
Drug
Participants with c-Met intermediate/High advanced non-Squamous mutEGFR NSCLC will receive ABBV-400 at RP2D.
Part 2a (wtEGFR Non-Small Cell Lung Cancer [NSCLC])
Drug
Participants with c-Met intermediate/high advanced non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D).
Part 1 (Monotherapy Dose Escalation)
Drug
Participants with advanced solid tumors will receive escalating doses of ABBV-400.
Part 2a (wtEGFR NSCLC)
Drug
Participants with c-Met overexpressing advanced non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to month 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to month 24 for reporting.

Closest Location

Virginia Cancer Specialists - Fairfax /ID# 231575 - Fairfax, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologic malignant solid tumor diagnosis (World Health Organization [WHO] criteria).
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
For Part 1 only - history of advanced solid tumor that has progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
For Part 2 only - history of advanced non-squamous wtEGFR or mutEGFR Non-Small Cell Lung Cancer (NSCLC) and are c-Met positive that has progressed after treatment per the protocol.
Should have no more than 2 lines of prior cytotoxic chemotherapy excluding adjuvant therapy and must have advanced NSCLC that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Laboratory values meeting the criteria outlined in the protocol.

Patient Q&A Section

What are the latest developments in abbv-400 for therapeutic use?

"Abbv-400 has been shown to be effective in reducing tumor size in animal models of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). In addition, abbv-400 has demonstrated antitumor effects in preclinical evaluations of breast cancer both as single agent therapy and combination therapy with other agents. Data from a recent study suggest that abbv-400 may represent a novel and promising anti-breast cancer therapeutic." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, non-small-cell lung?

"The most common cause of carcinoma, non-small-cell lung is cigarette smoking (https://www.[cancer](https://www.withpower.com/clinical-trials/cancer).gov/about-carcinomas/causes/lung-carcinoma.html). Other risk factors include being exposed to secondhand smoke, air pollution (e.g., tobacco smoke), and occupational exposure to chemicals or radiation. When a patient smokes, take them to see their doctor regularly as this is a major factor in managing lung cancer. If a smoker has already had a lung cancer diagnosis, they need to stop smoking immediately because smoking will accelerate the spread of cancer cells. If you are considering joining a lung cancer clinical trial, [Power](http://www.withpower." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, non-small-cell lung?

"The data show that there are many different treatments for carcinoma, non-small-cell lung (NSCLC). In addition, some of the treatments appear effective in NSCLC while others are ineffective. In view of the fact that no single treatment works well for all patients, we suggest that physicians consider initiating their patients on an appropriate combination of medications." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving abbv-400?

"Abbv-400 has demonstrated antitumor activity against both drug-sensitive and resistant HCC cell lines in vitro. Further evaluation on its antitumoral activity and tolerability will provide useful information for the development of future clinical trials." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, non-small-cell lung be cured?

"The present study suggests that radical surgery alone is not enough because there was no complete response rate found in patients who received chemotherapy only, compared with those who did not receive chemotherapy. Although the number of cases is very small, a prospective randomized controlled trial should be performed." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, non-small-cell lung?

"Carcinoma, non-small-cell lung (CNSL) is a disease with heterogeneous clinical manifestations and varied biological behaviors depending on the stage of the disease at diagnosis. The present study showed that the expression of EMT markers was closely associated with the development of CNSL from adenocarcinomas, especially invasive adenocarcinoma." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, non-small-cell lung spread?

"The speed of metastatic spread in NSCLC may be determined mainly by the length of time between diagnosis and therapy; however, other factors such as host-related variables also play a role." - Anonymous Online Contributor

Unverified Answer

What is abbv-400?

"There is evidence suggesting that ABBV-400 reduces the rate of tumour growth in mice with established tumor xenografts. However, there is limited data on human tumors and further work is needed before ABBV-400 can be safely tested as a therapeutic agent in humans." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

"There are more men with carcinoma and NSCLC In a recent study than women. In order to ascertain the true prevalence of these cancers in the US, the data obtained from this study should be compared with those obtained from previous studies of patients who underwent surgical resection for carcinoma. A nationwide survey should then be undertaken to assess the extent of the problem of carcinoma and NSCLC in the country." - Anonymous Online Contributor

Unverified Answer

Does carcinoma, non-small-cell lung run in families?

"Carcinoma, non-small-cell lung appears to be genetically heterogeneous. In contrast to previous suggestions, our data indicate that genetic susceptibility to this disease does not seem to be inherited. Further studies are needed to identify the genes involved in lung cancer susceptibility." - 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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