AB122 Platform Study

Sponsor
Taiho Pharmaceutical Co., Ltd.
Study ID
NCT04999761
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AB122 — DRUG
    AB122 will be administered with 360 mg/body given by infusion over 60 minutes Q3W.
  • AB122 — DRUG
    AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.
  • 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.
  • AB122 — DRUG
    AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.
  • 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.
  • AB122 — DRUG
    AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.
  • 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.
  • AB122 — DRUG
    AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.
  • 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.
  • AB122 — DRUG
    AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.
  • 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.
  • AB122 — DRUG
    AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.
  • 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.
  • AB122 — DRUG
    AB122 will be administered with 240 mg/body given by infusion over 60 minutes every 2 weeks.
  • 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.
  • Ramucirumab — DRUG
    Ramucirumab will be administered by infusion at a dose calculated using the body weight over approximately 60 minutes every 2 weeks.
  • AB122 — DRUG
    AB122 will be administered with 240 mg/body given by infusion over 60 minutes every 2 weeks.
  • TAS-102 — DRUG
    TAS-102 will be administered orally twice daily at a dose calculated based on 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.
  • Bevacizumab — DRUG
    Bevacizumab will be administered by infusion at a dose calculated using the body weight over approximately 90 minutes every 2 weeks.
  • AB122 — DRUG
    AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.
  • AB122 — DRUG
    AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.
  • 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.
  • Fluorouracil — DRUG
    Fluorouracil will be administered with 800 mg/m2/day given by continuous intravenous infusion from Day 1 to Day 5.
  • Cisplatin — DRUG
    Cisplatin will be administered with 80 mg/m2 given by infusion every 3 weeks.
  • AB122 — DRUG
    AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.
  • 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.
  • AB154 — DRUG
    AB154 will be administered with 1200 mg/body given by infusion over 60 minutes every 3 weeks.
  • AB122 — DRUG
    AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.
  • 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.
  • Fluorouracil — DRUG
    Fluorouracil will be administered with 1000 mg/m2/day given by continuous intravenous infusion from Day 1 to Day 4.
  • Carboplatin — DRUG
    Carboplatin will be administered with AUC 5 given by infusion every 3 weeks.
  • Cisplatin — DRUG
    Cisplatin will be administered with 100 mg/m2 given by infusion every 3 weeks.
  • AB122 — DRUG
    AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.
  • 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.
  • AB154 — DRUG
    AB154 will be administered with 1200 mg/body given by infusion over 60 minutes every 3 weeks.
  • AB122 — DRUG
    AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.
  • 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.
  • Carboplatin — DRUG
    Carboplatin will be administered with AUC 6 given by infusion every 3 weeks.
  • nab-Paclitaxel — DRUG
    Nab-Paclitaxel will be administered with 100 mg/m2 given by infusion on Day 1, Day 8 and Day 15.
  • AB122 — DRUG
    AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.
  • 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.
  • Cisplatin — DRUG
    Cisplatin will be administered with 25 mg/m2 given by infusion on Day 1 and Day 8.
  • Gemcitabine — DRUG
    Gemcitabine will be administered with 1000 mg/m2 given by infusion on Day 1 and Day 8.
  • AB122 — DRUG
    AB122 will be administered with 240 mg/body given by infusion over 60 minutes every 2 weeks.
  • 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.
  • nab-Paclitaxel — DRUG
    Nab-Paclitaxel will be administered with 125 mg/m2 given by infusion on Day 1, Day 8 and Day 15.
  • Gemcitabine — DRUG
    Gemcitabine will be administered with 1000 mg/m2 given by infusion on Day 1, Day 8 and Day 15.

Study Details

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.

Key Dates

First listed
Aug 11, 2021
Start date
Jun 1, 2021
Status verified
Sep 2024
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
917 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A-1
    AB122 will be given in participants with advanced or metastatic solid tumor.
  • Experimental: Cohort A-2
    AB122 will be given in participants with advanced or metastatic solid tumor.
  • Experimental: Cohort B-1
    AB122 will be given in combination with TAS-116 in participants with pancreatic ductal adenocarcinoma.
  • Experimental: Cohort B-2
    AB122 will be given in combination with TAS-116 in participants with unresectable metastatic MSS/pMMR CRC without liver metastases.
  • Experimental: Cohort B-3
    AB122 will be given in combination with TAS-116 in participants with unresectable metastatic non-squamous NSCLC without actionable gene alterations.
  • Experimental: Cohort D-1
    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.
  • Experimental: Cohort E-1
    AB122 will be given in combination with TAS-115 in participants with unresectable metastatic NSCLC without actionable gene alterations.
  • Experimental: Cohort E-2
    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.
  • Experimental: Cohort C-1
    AB122 will be given in combination with TAS-102 and Ramucirumab in participants with unresectable or recurrent gastric cancer or gastroesophageal junction cancer.
  • Experimental: Cohort C-2
    AB122 will be given in combination with TAS-102 and Bevacizumab in participants with unresectable metastatic CRC.
  • Experimental: Cohort D-2
    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.
  • Experimental: Cohort D-3
    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.
  • Experimental: Cohort D-4
    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.
  • Experimental: Cohort D-5
    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.
  • Experimental: Cohort D-6
    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.
  • Experimental: Cohort D-7
    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.
  • Experimental: Cohort D-8
    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.

Primary Outcome Measure

Phase 1a (All cohorts except Cohort D-4 and D-5) : Percentage of participants who experience a Dose Limiting Toxicity (DLT) [ Time Frame: From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q2W arm) ]

Central Contacts

Related Studies