Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0QMIBK
ADC Name
FOR-46
Synonyms
FOR 46; Anti-CD46 antibody drug conjugate
   Click to Show/Hide
Organization
University of California San Diego; Fortis Therapeutics, Inc.
Drug Status
Phase 1/2
Indication
In total 4 Indication(s)
Castration resistant prostate cancer [ICD11:2C82]
Phase 2
Hormone refractory prostate cancer [ICD11:2C82]
Phase 1
Multiple myeloma [ICD11:2A83]
Phase 1
Prostate cancer [ICD11:2C82]
Phase 1
Drug-to-Antibody Ratio
3.7
Structure
Antibody Name
Anti-CD46 fully human Anti-ody
  Antibody Info 
Antigen Name
Membrane cofactor protein (CD46)
  Antigen Info 
Payload Name
Monomethyl auristatin E
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
Undisclosed
Conjugate Type
Random conjugation through reduced inter-chain cysteines.
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Partial Response (PR)  NCT03575819
Phase 1
A phase 1 study of FOR46 administered every 21 days in patients with metastatic castration-resistant prostate cancer (mCRPC).
Undisclosed  NCT05011188
Phase 1/2
A phase 1b/2 study of FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer.
Undisclosed  NCT03650491
Phase 1
A phase 1 study of FOR46 administered every 21 days in patients with relapsed or refractory multiple myeloma (RRMM).
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Partial Response (PR)
22.20%
Patients Enrolled
Metastatic castration-resistant prostate cancer (CRPC).
Administration Dosage
Intravenous FOR46 on day 1 of every 21-day cycle. Dose levels ranged from 0.10 mg/kg. the starting dose level, to 3.00 mg/kg. The trial established 2.70 mg/kg to be the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of the agent.
Related Clinical Trial
NCT Number NCT03575819  Clinical Status Phase 1
Clinical Description A phase 1 study of FOR46 administered every 21 days in patients with metastatic castration-resistant prostate cancer (mCRPC).
Primary Endpoint
MtD and phase 1b dose=2.70 mg/kg.
Other Endpoint
18 pts had measurable lesions; 8 of 18 (44.44%) had tumor regression, with 4 (22.22%) confirmed partial responses (PR). The median duration of response is > 14 wks (range 9 -31+ weeks).
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT05011188  Clinical Status Phase 1/2
Clinical Description A phase 1b/2 study of FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer.
Experiment 3 Reporting the Activity Date of This ADC [3]
Related Clinical Trial
NCT Number NCT03650491  Clinical Status Phase 1
Clinical Description A phase 1 study of FOR46 administered every 21 days in patients with relapsed or refractory multiple myeloma (RRMM).
References
Ref 1 Phase 1a/1b study of FOR46, an antibody drug conjugate (ADC), targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC). Journal of Clinical Oncology 40, no. 16_suppl (June 01, 2022) 3001-3001.
Ref 2 A Phase 1b/2 Study of FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer, NCT05011188
Ref 3 A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM), NCT03650491

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