Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0PNWEY |
|||||
|---|---|---|---|---|---|---|
| Antibody Name | YS5 |
|||||
| Antigen Name | CD46 |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
FOR46 [Phase 2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
20%
|
|||
| Patients Enrolled |
Inclusion: Men ≥18 with histologically confirmed mCRPC (progressing post-ARSI therapy), castrate testosterone (<50 ng/dL), ECOG 0-1, adequate organ function, and willingness for biopsy (dose expansion). Exclusion: Persistent toxicity (Grade≥2 neuropathy), prior mCRPC chemotherapy (hormone-sensitive >6 months prior allowed), recent therapy/surgery (≤28 days), uncontrolled comorbidities (cardio/pulmonary/CNS metastases), active HIV/HepB/C, or CYP3A4 modulators. Dose escalation excludes episodic atrial fibrillation history.
Click to Show/Hide
|
||||
| Administration Dosage |
FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT03575819 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1 Study of FOR46 Administered Every 21 Days in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
|
||||
| Primary Endpoint |
Safety assessments include toxicity evaluation (type, incidence, severity, relatedness) and dose-limiting toxicities (DLTs) through 1-month post-treatment, along with disease response (≥50% PSA decline and objective response per RECIST criteria) assessed over 12 months.
|
||||
| Other Endpoint |
Pharmacokinetics focus on FOR46 plasma concentration (Cmax, AUC, half-life), antidrug antibody levels, and median radiographic progression-free survival (rPFS) at 12 months per PCWG3 criteria, monitored for 1 month post-dosing.
|
||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Inclusion: RRMM patients (≥18 years) refractory/intolerant to PI, IMiD, and CD38 therapy; ECOG 0-1; adequate organ function; contraception compliance. Exclusion: Persistent toxicity (Grade≥2 neuropathy), recent therapy/transplant/surgery (12-28 days), uncontrolled comorbidities (cardio/pulmonary/infectious), CYP3A4 modulators, warfarin use, atrial fibrillation history, or prior MMAE/MMAF ADC exposure. Breastfeeding excluded.
Click to Show/Hide
|
||||
| Administration Dosage |
FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT03650491 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
|
||||
| Primary Endpoint |
Safety evaluation includes monitoring treatment-related adverse events by NCI CTCAE v5.0 and dose-limiting toxicities through 1-month post-treatment. Efficacy is measured by overall response rate (≥PR/CR/stringent CR/MRD negativity) at 6 months.
|
||||
| Other Endpoint |
Pharmacokinetic analysis assesses FOR46 plasma concentration (Cmax, AUC, elimination half-life), antidrug antibody levels up to 1 month post-treatment, and treatment response (duration, progression-free survival, time to progression) via IMWG criteria over 6 months.
|
||||
| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Inclusion: Histologically confirmed prostate adenocarcinoma (excluding small cell/neuroendocrine) with mCRPC progression post-ARSI (abiraterone/enzalutamide/apalutamide/darolutamide); castrate testosterone (<50 ng/dL); ≥1 measurable metastasis; adequate organ function. Biopsy (fresh/archival ≤1 year) required for CD46 IHC. Exclusion: Prior CD46-targeted therapy, non-adenocarcinoma histology, >1 prior ARSI, recent anticancer therapy/radiation (≤28 days), actionable mutations (unless treated/progressed), prior chemotherapy (except 1 taxane in castration-sensitive setting >12 months prior), hypersensitivity to FG-3246/antibodies, malignancy (≤5 years, excluding treated skin cancers), or strong CYP3A4 modulators.
Click to Show/Hide
|
||||
| Administration Dosage |
FG-3246 will be administered per schedule specified in the arm description.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT06842498 | Clinical Status | PHASE2 | ||
| Clinical Description |
A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer
|
||||
| Primary Endpoint |
The study evaluates radiographic progression-free survival (rPFS) per RECIST v1.1 and PCWG3 criteria until progression (up to ~31 months), along with treatment-emergent adverse events (TEAEs) and pharmacokinetic parameters (Cmax of FG-3246, CD46 antibody, and free MMAE) across 21-day cycles. Safety monitoring continues until 28 days after the last dose.
Click to Show/Hide
|
||||
| Other Endpoint |
Efficacy assessments include 6- and 12-month rPFS rates, confirmed ORR, duration of response (DoR), PSA50/90 response rates, composite response (CRR), PSA-PFS, disease control (DCR), clinical benefit (CBR), time to symptomatic skeletal events (SSRE), and overall survival (OS) up to ~31 months. Immunogenicity (ADA/NAb development) is also tracked throughout treatment and post-dosing.
Click to Show/Hide
|
||||
| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Inclusion: Men ≥18 with mCRPC (progressed post-ARSIs, no prior mCRPC taxane, PSA≥2 ng/mL or measurable disease), castrate testosterone (<50 ng/dL), ECOG≤1, adequate organ function, and biopsy/PET imaging (expansion phase). Exclusion: Prior CD46 therapy, recent radiation/systemic therapy (<14 days), small-cell histology, uncontrolled cardiac/pulmonary/CNS conditions, CYP3A4 inhibitors, or active infections.
Click to Show/Hide
|
||||
| Administration Dosage |
A 3+3 dose escalation design was utilized with a starting dose of FOR46 of 1.8 mg/kg adjusted body weight (ABW) in combination with enza 160 mg/day. Dose escalation was explored with and without prophylactic granulocyte colony-stimulating factor (G-CSF) support.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05011188 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1b/2 Study of FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer
|
||||
| Primary Endpoint |
The Phase 1b trial evaluates the maximum tolerated dose (MTD) of FOR46 over 3 weeks by dose-escalation with cohorts of 3+3/6 patients-dose-limiting toxicities (DLTs, per CTCAE v5.0) determine escalation (stopped if ≥2/3-6 patients experience DLTs). Phase 2 assesses composite response rate (CRR; ≥50% PSA decline + RECIST 1.1 response) over 2 years with 95% CIs.
Click to Show/Hide
|
||||
| Other Endpoint |
Efficacy endpoints include PSA50 (≥50% PSA decline), ORR (RECIST 1.1), duration of response, time to PSA progression, rPFS (PCWG3), and median overall survival (Kaplan-Meier, 2-year follow-up). Safety tracks AE frequency/severity (CTCAE v5.0).
|
||||
| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| 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 6 Reporting the Activity Date of This ADC | [6] | ||||
| 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 7 Reporting the Activity Date of This ADC | [7] | ||||
| 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