Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0IPCHO
ADC Name
TAK-164
Synonyms
TAK 164; TAK164
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Organization
ImmunoGen, Inc.; Takeda Pharmaceutical Co., Ltd.
Drug Status
Phase 1
Indication
In total 2 Indication(s)
Colorectal cancer [ICD11:2B91]
Phase 1
Gastroesophageal cancer [ICD11:2B71]
Phase 1
Antibody Name
Anti-GCC human IgG1 mAb
  Antibody Info 
Antigen Name
GRIP and coiled-coil domain-containing protein 2 (GCC2); GRIP and coiled-coil domain-containing protein 1 (GCC1)
  Antigen Info 
Payload Name
DNA-damaging alkylating agent
  Payload Info 
Therapeutic Target
Human Deoxyribonucleic acid (hDNA)
  Target Info 
Linker Name
Peptide linker
  Linker Info 
Puchem SID
472421076
ChEBI ID
CHEMBL4297834
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT03449030
Phase 1
An open-label, dose escalation, phase 1, first-in-human study of TAK-164, an antibody-drug conjugate, in patients with advanced gastrointestinal cancers expressing guanylyl cyclase C.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
GCC-positive (H-score10 as indicated by IHC) GI cancers for whom standard treatment was no longer effective, or not available, Eligible GI malignancies included, but were not limited to: metastatic colorectal carcinoma, gastric carcinoma, esophageal carcinoma, small intestine cancer, and pancreatic cancer.
Administration Dosage
TAK-164 as a single intravenous infusion with a duration of up to 2 h, on day 1 of each 21-day cycle or every 3 weeks, until disease progression, unacceptable toxicity, or withdrawal from the study. Doses of 0.004 mg/kg, 0.008 mg/kg, 0.016 mg/kg, 0.032 mg/kg, 0.064 mg/kg, 0.12 mg/kg, 0.16 mg/kg, 0.19 mg/kg, 0.25 mg/kg, and 0.32 mg/kg were planned. To guide dose escalation, a method based on a Bayesian model of modified toxicity probability interval (mTPI) was used.

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Related Clinical Trial
NCT Number NCT03449030  Clinical Status Phase 1
Clinical Description An open-label, dose escalation, phase 1, first-in-human study of TAK-164, an antibody-drug conjugate, in patients with advanced gastrointestinal cancers expressing guanylyl cyclase C.
Primary Endpoint
Dosing was capped at 0.19 mg/kg due to hepatic toxicity. The RP2D was determined as 0.064 mg/kg but was considered insufficient to derive significant clinical benefit.
Other Endpoint
No pts had dose-limiting toxicities (DLT) in cycle 1 up to 0.32 mg/kg. TAK-164 appeared to have a manageable safety profile up to 0.064 mg/kg in pts with advanced GI cancers.
References
Ref 1 A phase I, first-in-human study of TAK-164, an antibody-drug conjugate, in patients with advanced gastrointestinal cancers expressing guanylyl cyclase C. Cancer Chemother Pharmacol. 2023 Apr;91(4):291-300.

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