Payload Information
General Information of This Payload
| Payload ID | PAY0GFWCQ |
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| Name | DM21-C |
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| Synonyms |
DM21-C
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| Target | Microtubule (MT) | |||||
| Structure |
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The activity data of This Payload
| Standard Type | Value | Units | Cell line | Disease Model | Cell line ID | Reference |
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| Inhibition rate | ≈10.3 | % |
SUN-5 cells
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Gastric carcinoma
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Undisclosed | [1] |
| Inhibition rate | ≈12.2 | % |
HPAF-II cells
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Pancreatic ductal adenocarcinoma
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[1] | |
| Inhibition rate | ≈49.5 | % |
MDA-MB-468 cells
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Breast adenocarcinoma
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[1] | |
| Inhibition rate | ≈69.4 | % |
BT-20 cells
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Invasive breast carcinoma of no special type
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[1] |
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
IMGC-936 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04622774 | Phase Status | Phase 1 | ||
| Clinical Description |
A phase 1/2, first-in-human, open-label, dose-escalation and expansion study of IMGC936 (Anti-ADAM9 antibody drug conjugate) in patients with advanced solid tumors.
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| Primary Endpoint |
During dose escalation measure incidence and severity of Treatment Emergent Adverse Events, During dose escalation characterize dose-limiting toxicities (DLTs), During expansion describe the overall response rate.
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| Other Endpoint |
During dose escalation and expansion to characterize study drug concentration and the concentration of anti-drug antibody, During dose expansion describe the duration of response and progression free survival, During dose escalation to describe the objective response rate and duration of response, During dose expansion measure incidence and severity of Treatment Emergent Adverse Events.
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| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Inclusion: Adults (≥18) with relapsed/refractory metastatic NSCLC (1-4 prior lines), TNBC (1-4 lines), CRC/GE/pancreatic cancer (1-3 lines), ECOG 0-1, adequate organ function (ANC≥1.5K/uL, platelets≥75K/uL, ALT/AST≤3×ULN, eGFR>30mL/min). Exclusion: Active CNS/ocular/cardiovascular disease (LVEF<50%, QTc>480ms), recent anticancer therapy (4w systemic/6w radiation), uncontrolled infections (HBV/HCV/COVID-19), or live vaccinations within 4w. Contraception required for 28w post-treatment.
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| Administration Dosage |
Participants received IMGC936 0.5, 1.0, 2.0, 4.0, 5.0, 6.0, 7.0 milligrams (mg)/kilogram (kg) via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
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| Related Clinical Trial | |||||
| NCT Number | NCT04622774 | Phase Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGC936 (Anti-ADAM9 Antibody Drug Conjugate) in Patients With Advanced Solid Tumors
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| Primary Endpoint |
Primary endpoints include TEAEs/SAEs monitoring (up to 3 years) and DLT assessment per CTCAE v5.0 (Cycle 1: 21/28 days) with hematologic/non-hematologic criteria including Grade 4 neutropenia/thrombocytopenia, ≥Grade 3 ocular/hepatic events, and Hy's law cases. Dose expansion phase evaluates ORR per RECIST v1.1 (CR: complete lesion disappearance; PR: ≥30% target lesion reduction).
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| Other Endpoint |
Secondary objectives comprise PK analysis (Cmax), ADA incidence, ORR/DOR/PFS per RECIST v1.1 (PD: ≥20% target lesion increase +5mm absolute growth), and safety monitoring (TEAEs leading to discontinuation). DOR/PFS analyzed via Kaplan-Meier method.
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Opugotamig olatansine [Phase 2]
Discovered Using Cell Line-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) |
100%
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Low FOLR1 expression (FOLR1+; IHC H-score=30) | ||
| Method Description |
IMGN151 activity was characterized against cell lines and xenograft models with a wide range of FR expression and compared to IMGN853.
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| In Vivo Model | OV-90 CDX model | ||||
| In Vitro Model | Ovarian adenocarcinoma | OV-90 cells | CVCL_3768 | ||
| Experiment 2 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) |
100%
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Moderate FOLR1 expression (FOLR1++; IHC H-score=100) | ||
| Method Description |
IMGN151 activity was characterized against cell lines and xenograft models with a wide range of FR expression and compared to IMGN853.
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| In Vivo Model | Ishikawa CDX model | ||||
| In Vitro Model | Endometrial adenocarcinoma | Ishikawa cells | CVCL_2529 | ||
| Experiment 3 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) |
100%
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Moderate FOLR1 expression (FOLR1++; IHC H-score=140) | ||
| Method Description |
IMGN151 activity was characterized against cell lines and xenograft models with a wide range of FR expression and compared to IMGN853.
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| In Vivo Model | IGROV-1 CDX model | ||||
| In Vitro Model | Ovarian endometrioid adenocarcinoma | IGROV-1 cells | CVCL_1304 | ||
| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) |
100%
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High FOLR1 expression (FOLR1+++; IHC H-score=300) | ||
| Method Description |
IMGN151 activity was characterized against cell lines and xenograft models with a wide range of FR expression and compared to IMGN853.
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| In Vivo Model | KB CDX model | ||||
| In Vitro Model | Human papillomavirus-related endocervical adenocarcinoma | KB cells | CVCL_0372 | ||
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Inclusion Criteria: ECOG PS 0-1, histologically confirmed recurrent/metastatic gynecologic cancers (specific requirements per cohort including prior therapy limits). Measureable disease by RECIST v1.1 (optimization/expansion phases), willingness to provide tumor tissue, recovery from prior toxicities (≤Grade 1), adequate organ function. Exclusion Criteria: Certain histologic subtypes, primary platinum-refractory disease (cohort B), >Grade 1 peripheral neuropathy, active ocular disorders, uncontrolled cardiac disease, CNS metastases, prior FRalpha-targeting agents (except cohort C), other malignancies within 3 years, pregnancy/lactation.
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| Administration Dosage |
IMGN151 is administered via intravenous (IV) infusion on Day 1 of Cycle 1 every 3-week cycle (Q3W).
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| Related Clinical Trial | |||||
| NCT Number | NCT05527184 | Phase Status | PHASE1 | ||
| Clinical Description |
A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (Anti-FRalpha Antibody-drug Conjugate) in Adult Patients With Recurrent Gynaecological Cancers
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| Primary Endpoint |
The study evaluates safety and tolerability of IMGN151 monotherapy through adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) within the first cycle (21 days). The recommended dose is determined over approximately 2 years.
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| Other Endpoint |
Pharmacokinetics (PK) of IMGN151 are assessed via maximum plasma concentration (Cmax), time to Cmax (Tmax), and area under the curve (AUC0-inf). Immunogenicity is measured through anti-drug antibodies (ADAs). Efficacy endpoints include objective response rate (ORR) and duration of response (DOR) per RECIST v1.1, evaluated over approximately 3 years.
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References