[M24-427]ABBV-400 in Select Advanced Solid Tumor Indications

JRCT ID: jRCT2031230534

Registered date:25/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HCC, PDAC, BTC, ESCC, BC, HNSCC
• Date of first enrollment: 25/12/2023
• Target sample size: 220
• Countries of recruitment: United states,Japan,Spain,Japan,France,Japan,Israel,Japan,Taiwan,Japan,Korea,Japan
• Study type: Interventional

Intervention(s)

Cohort 1: Hepatocellular Carcinoma (HCC)
Drug: ABBV-400
Intravenous (IV) Infusion

Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)
Drug: ABBV-400
Intravenous (IV) Infusion

Cohort 3: Biliary Tract Cancers (BTC)
Drug: ABBV-400
Intravenous (IV) Infusion

Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)
Drug: ABBV-400
Intravenous (IV) Infusion

Cohort 5: Triple Negative Breast Cancer (TNBC)
Drug: ABBV-400
Intravenous (IV) Infusion

Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)
Drug: ABBV-400
Intravenous (IV) Infusion

Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)
Drug: ABBV-400
Intravenous (IV) Infusion

Outcome(s)

Primary Outcome

- Objective Response Rate (ORR) [Time Frame: Up to 24 Months]
ORR defined as percentage of participants with confirmed best overall response of confirmed partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary Outcome

- Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR [Time Frame: Up to 24 Months]
DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.
- Clinical Benefit Rate [ Time Frame: Up to 24 Months ]
CBR is defined as the proportion of participants with a best overall response of stable disease at least 5 weeks post first dose, confirmed CR or PR per investigator review according to RECIST, version 1.1
- Progression-free Survival (PFS) [ Time Frame: Up to 24 Months ]
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) [ Time Frame: Up to 24 Months ]
OS is defined as time from first study treatment to death due to any cause.
- Maximum Observed Concentration (Cmax) of ABBV-400 [ Time Frame: Up to 24 Months ]
Cmax of ABBV-400.
- Time to Cmax (Tmax) of ABBV-400 [ Time Frame: Up to 24 Months ]
Tmax of ABBV-400.
- Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration [ Time Frame: Up to 24 Months ]
AUC for total antibody concentration.
- Total Antibody Drug Conjugate (ADC) Concentration [ Time Frame: Up to 24 Months ]
Total ADC concentration.
- Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload [ Time Frame: Up to 24 Months ]
Plasma concentrations of unconjugated Top1 inhibitor payload.
- Antidrug Antibody (ADA) [ Time Frame: Up to 24 Months ]
Incidence and concentration of anti-drug antibodies.
- Neutralizing Antidrug Antibody (nADA) [ Time Frame: Up to 24 Months ]
Incidence and concentration of neutralizing anti-drug antibodies.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Laboratory values meeting the criteria laid out in the protocol.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), or head and neck squamous-cell-carcinoma (HNSCC) (by World Health Organization [WHO] criteria). Participant meets the criteria for disease activity laid out in the protocol.
- Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy.

Exclude criteria

- Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400. Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10 fractions or less is permitted and not subject to a washout period.
- Unresolved AEs > Grade 1 from prior anticancer therapy except for alopecia.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
- History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol.
- Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue on antiepileptic therapy if required.
- History of other active malignancy, with the exception of those laid out in the protocol

Related Information

• Primary Sponsor: Yamagishi Chika
• Secondary ID(s): NCT06084481