Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0YAZBQ
ADC Name
RM-1995
Synonyms
RM 1995; RM-1995; RM1995
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Organization
Rakuten Medical, Inc.
Drug Status
Phase 1 (discontinued)
Antibody Name
Undisclosed
Antigen Name
Interleukin-2 receptor subunit alpha (IL2RA)
  Antigen Info 
Payload Name
IRDye 700DX
  Payload Info 
Linker Name
Undisclosed
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
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Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT05220748
PHASE1
A Phase 1 First-in-Human, Drug-dose Escalation Study of RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced Cutaneous Squamous Cell Carcinoma or With Head and Neck Squamous Cell Carcinoma

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Undisclosed  NCT05220748
Phase 1
A phase 1 first-in-human, drug-dose escalation study of RM-1995 photoimmunotherapy, as monotherapy or combined with pembrolizumab, in patients with advanced cutaneous squamous cell carcinoma or with head and neck squamous cell carcinoma.

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Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Key eligibility: Adults (≥18) with platinum-refractory HNSCC/cuSCC having accessible superficial lesions (≤1cm depth), measurable disease (RECIST 1.1), ECOG 0-2. Major exclusions: recent anticancer therapies (2 weeks/5 half-lives), active infections (HIV/HBV/HCV), QTc-prolonging medications, uncontrolled comorbidities, or hypersensitivity to antibody components. Tumor specimens required for pathology confirmation.

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Administration Dosage
RM-1995 will be administered by intravenous (IV) infusion followed approximately 24 hours later by tumor illumination with 690 nm non thermal red light using the PIT690 Laser System. The starting dose of RM-1995 will be 0.25 mg/kg and escalated up to 2.0 mg/kg over 6 dosing cohorts
Related Clinical Trial
NCT Number NCT05220748  Clinical Status PHASE1
Clinical Description A Phase 1 First-in-Human, Drug-dose Escalation Study of RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced Cutaneous Squamous Cell Carcinoma or With Head and Neck Squamous Cell Carcinoma
Primary Endpoint
Primary endpoints focus on safety evaluation (DLTs, AEs) and dose determination (MTD/MAD) for RM-1995 PIT monotherapy (Phase 1a) and combination therapy with pembrolizumab (Phase 1b) over 24 months in recurrent HNSCC/cuSCC patients.
Other Endpoint
Secondary objectives include PK analysis (RM-1995, total antibody, IR-700 concentrations) during treatment cycles and antitumor activity assessment (ORRPIT by RECIST 1.1/irRECIST) over 24 months.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT05220748  Clinical Status Phase 1
Clinical Description A phase 1 first-in-human, drug-dose escalation study of RM-1995 photoimmunotherapy, as monotherapy or combined with pembrolizumab, in patients with advanced cutaneous squamous cell carcinoma or with head and neck squamous cell carcinoma.
References
Ref 1 RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced CuSCC and HNSCC
Ref 2 A Phase 1 First-in-Human, Drug-dose Escalation Study of RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced Cutaneous Squamous Cell Carcinoma or With Head and Neck Squamous Cell Carcinoma, NCT05220748