Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05029882

Collaborator

(none)

190

Enrollment

Locations

Arms

44.3

Anticipated Duration (Months)

7.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and is associated with poor prognosis and limited treatment options. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.

ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Approximately 190 adult participants with NSCLC, or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 80-85 sites in the Dose Expansion phase worldwide.

In the biomarker-selected dose expansion arms, participants in the following c-Met overexpressing advanced solid tumor indications: c-Met-intermediate/high non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) (Part 2a) or mutated EGFR-expression (mutEGFR NSCLC) (Part 2b), c-Met low non-squamous wtEGFR NSCLC (Part 2c), squamous NSCLC (Part 2d), and GEA (Part 3) will receive intravenous (IV) ABBV-400 monotherapy.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer Advanced Solid Tumors Gastroesophageal Adenocarcinoma	Drug: ABBV-400	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

190 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 in Adult Subjects With Advanced Solid Tumors

Actual Study Start Date :

Oct 13, 2021

Anticipated Primary Completion Date :

Jun 22, 2025

Anticipated Study Completion Date :

Jun 22, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 (Monotherapy Dose Escalation) Participants with advanced solid tumors will receive escalating doses of ABBV-400.	Drug: ABBV-400 Intravenous (IV) Infusion
Experimental: Part 2a (wtEGFR Non-Small Cell Lung Cancer [NSCLC]) Participants with c-Met intermediate/high advanced non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D).	Drug: ABBV-400 Intravenous (IV) Infusion
Experimental: Part 2b (mutEGFR NSCLC) Participants with c-Met intermediate/High advanced non-Squamous mutEGFR NSCLC will receive ABBV-400 at RP2D.	Drug: ABBV-400 Intravenous (IV) Infusion
Experimental: Part 2c (wtEGFR NSCLC) Participants with c-Met low non-squamous wtEGFR NSCLC will receive ABBV-400 at RP2D.	Drug: ABBV-400 Intravenous (IV) Infusion
Experimental: Part 2d (Squamous NSCLC) Participants with squamous NSCLC will receive ABBV-400 at RP2D.	Drug: ABBV-400 Intravenous (IV) Infusion
Experimental: Part 3 (Gastric/Gastroesophageal Junction Adenocarcinoma) Participants with c-Met overexpressing Gastroesophageal adenocarcinoma will receive ABBV-400 at the RP2D.	Drug: ABBV-400 Intravenous (IV) Infusion

Outcome Measures

Primary Outcome Measures

Change it to Objective Response Rate (ORR) [Up to Month 24]
ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary Outcome Measures

Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1 [Up to 24 Months]
DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.
PFS per RECIST v1.1 [Up to 24 Months]
Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Overall survival (OS) [Up to 24 Months]
Overall survival (OS) is defined as time from first study treatment to death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 c-Met overexpressing non-squamous wtEGFR or mutEGFR or history of advanced c-Met overexpressing squamous Non-Small Cell Lung Cancer (NSCLC) that have 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.
For Part 3 only - history of advanced histopathologically or cytologically confirmed diagnosis of c-Met overexpressing GEA that has progressed after treatment with at least:
1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and has not received >= 2 prior lines of cytotoxic chemotherapy regimens in the locally advanced or metastatic setting.
If applicable, an immune checkpoint inhibitor.
If applicable, human epidermal growth factor receptor 2 (HER2) directed therapy.
If applicable, standard of care targeted therapy.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Laboratory values meeting the criteria outlined in the protocol.

Exclusion Criteria:

History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles /ID# 243841	Santa Monica	California	United States	90404-2125
2	Univ of Colorado Cancer Center /ID# 231574	Aurora	Colorado	United States	80045
3	Indiana University Melvin and Bren Simon Cancer Center /ID# 245133	Indianapolis	Indiana	United States	46202-5112
4	Community Health Network, Inc. /ID# 245331	Indianapolis	Indiana	United States	46250-2042
5	START Midwest /ID# 231551	Grand Rapids	Michigan	United States	49546-7062
6	Carolina BioOncology Institute /ID# 231541	Huntersville	North Carolina	United States	28078
7	NEXT Oncology /ID# 231578	San Antonio	Texas	United States	78229-6028
8	Virginia Cancer Specialists - Fairfax /ID# 231575	Fairfax	Virginia	United States	22031
9	Centre Antoine Lacassagne - Nice /ID# 231730	Nice	Alpes-Maritimes	France	06189
10	Institut Curie /ID# 231597	Paris CEDEX 05	Ile-de-France	France	75248
11	CHU de Nantes, Hotel Dieu -HME /ID# 245266	Nantes	Pays-de-la-Loire	France	44000
12	Centre Georges François Leclerc /ID# 244450	Dijon		France	21079
13	The Chaim Sheba Medical Center /ID# 231217	Ramat Gan	Tel-Aviv	Israel	5265601
14	Hadassah Medical Center /ID# 243821	Jerusalem	Yerushalayim	Israel	9112001
15	Rambam Health Care Campus /ID# 231218	Haifa		Israel	3109601
16	Meir Medical Center /ID# 244179	Kfar Sava		Israel	4428164
17	Rabin Medical Center /ID# 243363	Peta Tikva		Israel	4941492
18	National Cancer Center Hospital East /ID# 232008	Kashiwa-shi	Chiba	Japan	277-8577
19	National Cancer Center Hospital /ID# 232007	Chuo-ku	Tokyo	Japan	104-0045
20	Seoul National University Hospital /ID# 244667	Seoul		Korea, Republic of	03080
21	Asan Medical Center /ID# 245215	Seoul		Korea, Republic of	05505
22	Pan American Center for Oncology Trials, LLC /ID# 231580	Rio Piedras		Puerto Rico	00935
23	Hospital Universitario Fundacion Alcorcon /ID# 244505	Alcorcón	Madrid	Spain	28922
24	Hospital Clinic de Barcelona /ID# 245374	Barcelona		Spain	08036
25	Hospital Universitario Fundacion Jimenez Diaz /ID# 231464	Madrid		Spain	28040
26	Hospital Universitario Miguel Servet /ID# 244456	Zaragoza		Spain	50009