Antibody Information

General Information of This Antibody
Antibody ID
ANI0SPXDP
Antibody Name
Praluzatamab
Organization
CytomX Therapeutics Inc.
Indication
Solid tumors
Synonyms
CX-191; CX 191; CX191; ANTI-CD166 PROBODY-DRUG
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Antibody Type
Monoclonal antibody (mAb)
Antibody Subtype
Humanized IgG1-kappa
Antigen Name
CD166 antigen (ALCAM)
  Antigen Info 
ChEMBI ID
CHEMBL4650251
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Heavy Chain Sequence
QITLKESGPTLVKPTQTLTLTCTFSGFSLSTYGMGVGWIRQPPGKALEWLANIWWSEDKH
YSPSLKSRLTITKDTSKNQVVLTITNVDPVDTATYYCVQIDYGNDYAFTYWGQGTLVTVS
SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS
SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLG
GPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQY
NSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRE
EMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSR
WQQGNVFSCSVMHEALHNHYTQKSLSLSPG
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Heavy Chain Varible Domain
QITLKESGPTLVKPTQTLTLTCTFSGFSLSTYGMGVGWIRQPPGKALEWLANIWWSEDKH
YSPSLKSRLTITKDTSKNQVVLTITNVDPVDTATYYCVQIDYGNDYAFTYWGQGTLVTVS
S
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Heavy Chain Constant Domain 1
ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS
GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKV
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Heavy Chain Constant Domain 2
APELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTK
PREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAK
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Heavy Chain Constant Domain 3
GQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDS
DGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
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Heavy Chain Hinge Region
EPKSCDKTHTCPPCP
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Heavy Chain CDR 1
GFSLSTYGMG
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Heavy Chain CDR 2
IWWSEDK
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Heavy Chain CDR 3
VQIDYGNDYAFTY
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Light Chain Sequence
QGQSGQGLCHPAVLSAWESCSSGGGSSGGSAVGLLAPPGGLSGRSDNHGGSDIVMTQSPL
SLPVTPGEPASISCRSSKSLLHSNGITYLYWYLQKPGQSPQLLIYQMSNLASGVPDRFSG
SGSGTDFTLKISRVEAEDVGVYYCAQNLELPYTFGQGTKLEIKRTVAAPSVFIFPPSDEQ
LKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKA
DYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Light Chain Varible Domain
DIVMTQSPLSLPVTPGEPASISCRSSKSLLHSNGITYLYWYLQKPGQSPQLLIYQMSNLA
SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCAQNLELPYTFGQGTKLEIK
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Light Chain Constant Domain
RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQD
SKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Light Chain CDR 1
KSLLHSNGITY
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Light Chain CDR 2
QMS
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Light Chain CDR 3
AQNLELPYT
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Praluzatamab ravtansine [Phase 2 (discontinued)]
 ADC Info 
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]
Patients Enrolled
Inclusion: (Arm A) HR+/HER2- breast cancer (0-2 prior metastatic chemo); (Arms B/C) CD166+ TNBC (1-3 prior lines; Arm C requires PD-L1+ by FDA test). All: RECIST-measurable disease, ECOG 0-1, adequate labs, contraception. Stable brain mets (≤1 cm/asymptomatic) allowed. Exclusion: Active malignancy (2 years), untreated symptomatic CNS mets, unresolved toxicity (Grade>1), corneal disorders, transplants. Arm C: Autoimmune disease/CPI intolerance, immunosuppressive steroids (>10 mg prednisone), maytansinoid exposure, pregnancy. Exceptions require Medical Monitor approval.

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Administration Dosage
Intravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W)
Related Clinical Trial
NCT Number NCT04596150  Clinical Status PHASE2
Clinical Description
A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination With Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)
Primary Endpoint
The primary endpoint is Objective Response Rate (ORR) over 30 months, defined as the proportion of patients achieving CR or PR per RECIST v1.1 via Central Radiology Review.
Other Endpoint
Secondary outcomes include Investigator-assessed PFS (time to progression/death), DoR (time from response to progression), OS (time to death), and Clinical Benefit Rate (responses + stable disease at 16/24 weeks) over 30 months.
Experiment 2 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Inclusion: Metastatic/locally advanced unresectable tumors with progression post-standard therapy or intolerance; archival/fresh biopsy; ≥18 years. Exclusion: Active corneal disorders, serious infections, autoimmune/cardiac diseases, neurological conditions (e.g., stroke within 6 months, demyelinating disorders), non-healing wounds, monoclonal antibody allergies, warfarin use, or major surgery within 3 months.

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Administration Dosage
In this phase I multi-part dose-escalation study, pts with advanced solid tumors received CX-2009 0.25-10 mpk IV every 14 or 21 days (Q2W or Q3W). Tumor types were selected based on expected high CD166 expression and MTI sensitivity.
Related Clinical Trial
NCT Number NCT03149549  Clinical Status PHASE1|||PHASE2
Clinical Description
A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)
Primary Endpoint
The study evaluates Dose Limiting Toxicity (DLT) occurrence across CX-2009 monotherapy dose levels, captured via NCI CTCAE v4.03 criteria during 21-day (Q3W) or 28-day (Q2W) cycles per protocol-defined DLT thresholds.
Other Endpoint
Anti-cancer activity is measured by Objective Response Rate (ORR) per RECIST 1.1, requiring confirmed CR/PR on consecutive tumor assessments ≥4 weeks apart. Imaging (CT/MRI) occurs every 8 (±1) weeks until progression, with median follow-up of 18.4 weeks.
Experiment 3 Reporting the Activity Date of This ADC [3]
Efficacy Data Partial Response (PR)
9%
Patients Enrolled
Eastern Cooperative Oncology Group (ECOG) 0, 1, metastatic or locally advanced unresectable solid tumors with progressive disease (PD) after standard treatment or known intolerance to available treatment, based on the predicted prevalence of CD166 expression, were breast cancer, castration-resistant prostate cancer, nonsmall cell lung cancer (NSCLC), epithelial ovarian cancer, head and neck squamous cell cancer (HNSCC), cholangiocarcinoma, and endometrial carcinoma.

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Administration Dosage
Scalating doses every 3 weeks (0.25-10 mg/kg) or every 2 weeks (4-6 mg/kg), IV.
Related Clinical Trial
NCT Number NCT03149549  Clinical Status Phase 1/2
Clinical Description
A phase 1-2, open-label, dose-finding, proof of concept, first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CX-2009 in adults with metastatic or locally advanced unresectable solid tumors (PROCLAIM-CX-2009).
Primary Endpoint
Median number of prior therapies was 5. On the basis of tolerability, the RP2D was 7 mg/kg every 3 weeks. Tumor regressions were observed at doses 4 mg/kg.
References
Ref 1 Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer
Ref 2 PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors
Ref 3 Praluzatamab Ravtansine, a CD166-Targeting Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors: An Open-Label Phase I/II Trial. Clin Cancer Res. 2022 May 13;28(10):2020-2029.