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AB122

Phase 1

Advanced or Metastatic Solid Tumor | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Sep 25, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment917
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04999761AB122 Platform StudyPHASE1 RECRUITING 917 — — Jun 1, 2021May 1, 2026Sep 25, 20249 Japan
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Study Endpoints
Primary Endpoints
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)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A-1EXPERIMENTALAB122 will be given in participants with advanced or metastatic solid tumor.
Cohort A-2EXPERIMENTALAB122 will be given in participants with advanced or metastatic solid tumor.
Cohort B-1EXPERIMENTALAB122 will be given in combination with TAS-116 in participants with pancreatic ductal adenocarcinoma.
Cohort B-2EXPERIMENTALAB122 will be given in combination with TAS-116 in participants with unresectable metastatic MSS/pMMR CRC without liver metastases.
Cohort B-3EXPERIMENTALAB122 will be given in combination with TAS-116 in participants with unresectable metastatic non-squamous NSCLC without actionable gene alterations.
Cohort D-1EXPERIMENTALAB122 will be given in combination with TAS-120 in participants with unresectable metastatic NSCLC with PD-L1 high expression and without actionable gene alterations.
Cohort E-1EXPERIMENTALAB122 will be given in combination with TAS-115 in participants with unresectable metastatic NSCLC without actionable gene alterations.
Cohort E-2EXPERIMENTALAB122 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.
Cohort C-1EXPERIMENTALAB122 will be given in combination with TAS-102 and Ramucirumab in participants with unresectable or recurrent gastric cancer or gastroesophageal junction cancer.
Cohort C-2EXPERIMENTALAB122 will be given in combination with TAS-102 and Bevacizumab in participants with unresectable metastatic CRC.
Cohort D-2EXPERIMENTALAB122 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.
Cohort D-3EXPERIMENTALAB122 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.
Cohort D-4EXPERIMENTALAB122 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.
Cohort D-5EXPERIMENTALAB122 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.
Cohort D-6EXPERIMENTALAB122 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.
Cohort D-7EXPERIMENTALAB122 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.
Cohort D-8EXPERIMENTALAB122 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.
Interventions
NameTypeDescription
AB122DRUGAB122 will be administered with 360 mg/body given by infusion over 60 minutes Q3W.
TAS-116DRUGTAS-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.
TAS-120DRUGTAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.
TAS-115DRUGTAS-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.
TAS-102DRUGTAS-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.
RamucirumabDRUGRamucirumab will be administered by infusion at a dose calculated using the body weight over approximately 60 minutes every 2 weeks.
BevacizumabDRUGBevacizumab will be administered by infusion at a dose calculated using the body weight over approximately 90 minutes every 2 weeks.
FluorouracilDRUGFluorouracil will be administered with 800 mg/m2/day given by continuous intravenous infusion from Day 1 to Day 5.
CisplatinDRUGCisplatin will be administered with 80 mg/m2 given by infusion every 3 weeks.
AB154DRUGAB154 will be administered with 1200 mg/body given by infusion over 60 minutes every 3 weeks.
CarboplatinDRUGCarboplatin will be administered with AUC 5 given by infusion every 3 weeks.
nab-PaclitaxelDRUGNab-Paclitaxel will be administered with 100 mg/m2 given by infusion on Day 1, Day 8 and Day 15.
GemcitabineDRUGGemcitabine will be administered with 1000 mg/m2 given by infusion on Day 1 and Day 8.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * 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...

Countries:Japan
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Competitive Landscape -Other Solid Tumors 9 trials
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Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04999761studyFirstPostDate: changed