General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0BGQOD
ADC Name
Olintatug tesirine
Synonyms
olintatug tesirine; 3A4-PL1601; ADCT-901
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Organization
ADC Therapeutics (Originator);MedImmune (Top20 MNC);Overland Pharmaceuticals
Drug Status
Phase 1 (discontinued)
Structure
Antibody Name
Olintatug
 Antibody Info 
Antigen Name
Kidney-associated antigen 1 (KAAG1)
 Antigen Info 
Payload Name
SG3199 (SC-DR002)
 Payload Info 
Payload Target
Human deoxyribonucleic acid (hDNA)
 Target Info 
Linker Name
Mal-PEG8-Val-Ala-PABC
 Linker Info 
Conjugate Type
Random Cysteines
Combination Type
tesirine
2027 Update
The indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
Indication Phase 1 Phase 2 Phase 3 Approved
Biliary tract cancer
1 Trials
Trial ID
NCT04972981; EudraCT2021-002292-19; EUCT2022-500115-39-00
Breast cancer
1 Trials
Trial ID
NCT04972981; EudraCT2021-002292-19; EUCT2022-500115-39-00
Ovarian cancer
1 Trials
Trial ID
NCT04972981; EudraCT2021-002292-19; EUCT2022-500115-39-00
Fallopian tube cancer
1 Trials
Trial ID
NCT04972981; EudraCT2021-002292-19; EUCT2022-500115-39-00
Prostate cancer
1 Trials
Trial ID
NCT04972981; EudraCT2021-002292-19; EUCT2022-500115-39-00
Kidney cancer
1 Trials
Trial ID
NCT04972981; EudraCT2021-002292-19; EUCT2022-500115-39-00
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  NCT04972981
PHASE1
A Phase 1, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 as Monotherapy in Patients With Selected Advanced Solid Tumors

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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
Eligible participants had advanced/metastatic solid tumors (cholangiocarcinoma, ovarian/prostate/RCC/TNBC), measurable disease per RECIST v1.1 (prostate cancer allowed with bone metastases + PSA ≥2 ng/mL). Exclusions included active infections, symptomatic CNS metastases (unless treated/asymptomatic for ≥4 weeks), clinically significant effusions, CTCAE Grade 2+ diarrhea, ocular surface disease (except managed mild dry eye), and recent experimental drug use (14-day washout).

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Administration Dosage
Part 1: pts will receive escalating doses of ADCT-901 guided by a 3+3 design (1st dose: 15 ug/kg every 3 weeks [Q3W]; highest dose: 290 ug/kg Q3W). Dose escalation will be evaluated by administering the lowest dose to first 3 pts, then increasing/decreasing the dose based on dose-limiting toxicity (DLT) experienced by pts.
Related Clinical Trial
NCT Number NCT04972981  Clinical Status PHASE1
Clinical Description A Phase 1, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 as Monotherapy in Patients With Selected Advanced Solid Tumors
Primary Endpoint
Safety was evaluated by AE/SAE incidence (including clinical lab/ECG changes) over 2.5 years, with DLTs tracked during dose escalation (Days 1-21), alongside dose modifications (interruptions/reductions).
Other Endpoint
Efficacy endpoints (ORR, DOR, PFS, OS) and comprehensive PK parameters (Cmax, Tmax, AUC metrics, half-life, clearance, ADA response) for ADCT-901 components (total antibody, PBD-conjugated antibody, SG3199) were monitored throughout the 2.5-year study period.
References
Ref 1 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors