AB122 Platform Study

NCT04999761 | Recruiting Phase 1 DMC

• 1 other identifier: 10071010
• Study Type: interventional
• Target: 917
• Locations: 1 country
• Sites: 9

Brief Summary

This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.

Conditions

Advanced or Metastatic Solid Tumor; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Non-small Cell Lung Cancer; Gastric Cancer; Alveolar Soft Part Sarcoma; Esophageal Cancer; Head and Neck Cancer; Biliary Tract Cancer

Outcome Measures

Primary Outcomes (4)

• Phase 1a (All cohorts except Cohort D-4 and D-5) : Percentage of participants who experience a Dose Limiting Toxicity (DLT)

  From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q2W arm)

• Phase 1a (Cohort D-4 and D-5) : Percentage of adverse events and treatment-related adverse events.

  From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q2W arm)

• Phase 1b (Cohort B-n, D-n and E-n) : Objective Response Rate (ORR)

  Through completion of treatment (estimated up to be 11 months)

• Phase 1b (Cohort C-n): The 6-month PFS proportion by RECIST v1.1

  Through completion of treatment (estimated up to be 11 months)

Study Arms (17)

Cohort A-1

EXPERIMENTAL

AB122 will be given in participants with advanced or metastatic solid tumor.

Drug: AB122

Cohort A-2

EXPERIMENTAL

AB122 will be given in participants with advanced or metastatic solid tumor.

Drug: AB122

Cohort B-1

EXPERIMENTAL

AB122 will be given in combination with TAS-116 in participants with pancreatic ductal adenocarcinoma.

Drug: AB122; Drug: TAS-116

Cohort B-2

EXPERIMENTAL

AB122 will be given in combination with TAS-116 in participants with unresectable metastatic MSS/pMMR CRC without liver metastases.

Drug: AB122; Drug: TAS-116

Cohort B-3

EXPERIMENTAL

AB122 will be given in combination with TAS-116 in participants with unresectable metastatic non-squamous NSCLC without actionable gene alterations.

Drug: AB122; Drug: TAS-116

Cohort D-1

EXPERIMENTAL

AB122 will be given in combination with TAS-120 in participants with unresectable metastatic NSCLC with PD-L1 high expression and without actionable gene alterations.

Drug: AB122; Drug: TAS-120

Cohort E-1

EXPERIMENTAL

AB122 will be given in combination with TAS-115 in participants with unresectable metastatic NSCLC without actionable gene alterations.

Drug: AB122; Drug: TAS-115

Cohort E-2

EXPERIMENTAL

AB122 will be given in combination with TAS-115 in participants with unresectable metastatic ASPS, in those who received or no prior regimen for advanced disease.

Drug: AB122; Drug: TAS-115

Cohort C-1

EXPERIMENTAL

AB122 will be given in combination with TAS-102 and Ramucirumab in participants with unresectable or recurrent gastric cancer or gastroesophageal junction cancer.

Drug: AB122; Drug: TAS-102; Drug: Ramucirumab

Cohort C-2

EXPERIMENTAL

AB122 will be given in combination with TAS-102 and Bevacizumab in participants with unresectable metastatic CRC.

Drug: AB122; Drug: TAS-102; Drug: Bevacizumab

Cohort D-2

EXPERIMENTAL

AB122 will be given in combination with TAS-120, Fluorouracil and Cisplatin in participants with histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus with no prior treatment for advanced cancer.

Drug: AB122; Drug: TAS-120; Drug: Fluorouracil; Drug: Cisplatin

Cohort D-3

EXPERIMENTAL

AB122 will be given in combination with TAS-120 and AB154 in participants with histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus with no prior treatment for advanced cancer or who have been previously treated with one line of chemotherapy.

Drug: AB122; Drug: TAS-120; Drug: AB154

Cohort D-4

EXPERIMENTAL

AB122 will be given in combination with TAS-120, Fluorouracil and Cisplatin/Carboplatin in participants with histologically diagnosed advanced or metastatic squamous cell carcinoma of the head and neck (middle pharynx, oral cavity, hypopharynx, larynx) with no prior treatment for advanced cancer. ・The validity of enrollment in the cohort must be confirmed, taking into account the patient background including CPS and the guidelines for head and neck cancer treatment.

Drug: AB122; Drug: TAS-120; Drug: Fluorouracil; Drug: Carboplatin; Drug: Cisplatin

Cohort D-5

EXPERIMENTAL

AB122 will be given in combination with TAS-120 and AB154 in participants with histologically diagnosed advanced or metastatic squamous cell carcinoma of the head and neck (middle pharynx, oral cavity, hypopharynx, larynx) with no prior treatment for advanced cancer. ・The validity of enrollment in the cohort must be confirmed, taking into account the patient background including CPS and the guidelines for head and neck cancer treatment.

Drug: AB122; Drug: TAS-120; Drug: AB154

Cohort D-6

EXPERIMENTAL

AB122 will be given in combination with TAS-120, Carboplatin and nab-Paclitaxel in participants with unresectable metastatic squamous NSCLC patients with no prior treatment for advanced cancer.

Drug: AB122; Drug: TAS-120; Drug: Carboplatin; Drug: nab-Paclitaxel

Cohort D-7

EXPERIMENTAL

AB122 will be given in combination with TAS-120, Cisplatin and Gemcitabine in participants with unresectable metastatic adenocarcinoma or adenosquamous biliary tract cancer patients with no prior treatment for advanced cancer.

Drug: AB122; Drug: TAS-120; Drug: Cisplatin; Drug: Gemcitabine

Cohort D-8

EXPERIMENTAL

AB122 will be given in combination with TAS-120, nab-Paclitaxel and Gemcitabine in participants with unresectable metastatic Pancreatic ductal adenocarcinoma patients with no prior treatment for advanced cancer.

Drug: AB122; Drug: TAS-120; Drug: nab-Paclitaxel; Drug: Gemcitabine

Interventions

AB122 DRUG

AB122 will be administered with 360 mg/body given by infusion over 60 minutes Q3W.

Cohort A-2

TAS-116 DRUG

TAS-116 will be administered orally in 5-day on and 2-day off schedule on an empty stomach at least 1 hour before or 2 hour after eating.

Cohort B-1

TAS-120 DRUG

TAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.

Cohort D-1

TAS-115 DRUG

TAS-115 will be administered orally in 5-day on and 2-day off schedule on an empty stomach at least 1 hour before or 2 hours after eating.

Cohort E-1

TAS-102 DRUG

TAS-102 will be administered orally twice daily at a dose calculated based on body surface area (BSA) within 1 hour after morning and evening meals for 5 days, a week with 2 days rest for 2 weeks, followed by a 14-day rest, repeated every 4 weeks.

Cohort C-1

Ramucirumab DRUG

Ramucirumab will be administered by infusion at a dose calculated using the body weight over approximately 60 minutes every 2 weeks.

Cohort C-1

Bevacizumab DRUG

Bevacizumab will be administered by infusion at a dose calculated using the body weight over approximately 90 minutes every 2 weeks.

Cohort C-2

Fluorouracil DRUG

Fluorouracil will be administered with 800 mg/m2/day given by continuous intravenous infusion from Day 1 to Day 5.

Cohort D-2

Cisplatin DRUG

Cisplatin will be administered with 80 mg/m2 given by infusion every 3 weeks.

Cohort D-2

AB154 DRUG

AB154 will be administered with 1200 mg/body given by infusion over 60 minutes every 3 weeks.

Cohort D-3

Carboplatin DRUG

Carboplatin will be administered with AUC 5 given by infusion every 3 weeks.

Cohort D-4

nab-Paclitaxel DRUG

Nab-Paclitaxel will be administered with 100 mg/m2 given by infusion on Day 1, Day 8 and Day 15.

Cohort D-6

Gemcitabine DRUG

Gemcitabine will be administered with 1000 mg/m2 given by infusion on Day 1 and Day 8.

Cohort D-7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);
• Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;
• Has adequate organ function as defined by the following criteria:
• AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN
• T-Bil of ≤ 1.5 × ULN
• ANC ≥ 1500 /mm3 (ie, ≥ 1.5 × 109 /L by International System of Units \[SI\]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor \[G-CSF\])
• Platelet count ≥ 100000 /mm3 (SI: ≥ 100 × 109 /L) (excluding measurements obtained within 7 days after a transfusion of platelets)
• Hemoglobin value of ≥ 9.0 g/dL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood
• Has a life expectancy of at least 90 days;
• Cohort A-1 and A-2
• Japanese male and female;
• Has a histologically or cytologically confirmed diagnosis of solid tumor;
• Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;
• Cohort B-1
• Has a histologically or cytologically confirmed diagnosis of PDAC;

You may not qualify if:

• History or current evidence of cardiac arrhythmia and/or conduction abnormality: Any factor that can increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, etc.;
• Treatment with any of the following within the specified time frame prior to the day on which study treatment is scheduled to be started:
• Major surgery within 4 weeks (the surgical incision should be fully healed prior to the day on which study treatment is scheduled to be started);
• Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;
• Any anticancer therapy within 2 weeks;
• Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever shorter;
• Unresolved toxicity of ≥ Grade 2 attributed to any prior therapies (excluding anemia, peripheral sensory neuropathy, alopecia and skin pigmentation);
• A serious illness or medical condition(s) including, but not limited to, the following specific medical conditions:
• Known acute systemic infection;
• Known medical history of interstitial lung disease/ drug-induced interstitial lung disease/ radiation pneumonitis which required steroid treatment/ any evidence of clinically active interstitial lung disease;
• Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV, Appendix A) within the previous 6 months; if \> 6 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms;
• Known severe chronic kidney disease;
• Known positivity of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody in baseline virus test. In addition, the patient who is known negative in HCV ribonucleic acid (RNA) is eligible, even if positive for HCV antibody;
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment, or may interfere with the interpretation of study results, and in the judgment of the investigator or sub-investigator would make the patient inappropriate for entry into this study;
• Previous or concurrent cancer that is distinct in primary disease or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia, or any cancer curatively treated \> 5 years prior to the day on which study treatment is scheduled to be started;

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (9)

A site selected by Taiho Pharmaceutical Co., Ltd.

Aichi, Japan

RECRUITING

A site selected by Taiho Pharmaceutical Co., Ltd.

Chiba, Japan

RECRUITING

A site selected by Taiho Pharmaceutical Co., Ltd.

Ehime, Japan

RECRUITING

A site selected by Taiho Pharmaceutical Co., Ltd.

Hokkaido, Japan

RECRUITING

A site selected by Taiho Pharmaceutical Co., Ltd.

Kanagawa, Japan

RECRUITING

A site selected by Taiho Pharmaceutical Co., Ltd.

Osaka, Japan

RECRUITING

A site selected by Taiho Pharmaceutical Co., Ltd.

Shizuoka, Japan

RECRUITING

A site selected by Taiho Pharmaceutical Co., Ltd.

Tokyo, Japan

RECRUITING

A site selected by Taiho Pharmaceutical Co., Ltd.

Wakayama, Japan

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms; Sarcoma, Alveolar Soft Part; Esophageal Neoplasms; Head and Neck Neoplasms; Biliary Tract Neoplasms

Interventions

TAS-116; futibatinib; 4-(2-fluoro-4-((((2-phenylacetyl)amino)thioxomethyl)amino)phenoxy)-7-methoxy-N-methyl-6-quinolinecarboxamide; trifluridine tipiracil drug combination; Ramucirumab; Bevacizumab; Fluorouracil; Cisplatin; Carboplatin; 130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Stomach Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma; Esophageal Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Study Officials

• Taiho Pharmaceutical Co., Ltd.

  Taiho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Drug Information Center

CONTACT

+81-3-3294-4527; toiawase@taiho.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 11, 2021
• Study Start: June 1, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (9)