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Association details:
| Biomarker: | CEACAM5 expression |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | tusamitamab ravtansine (SAR408701) (Microtubule inhibitor, CEACAM5-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Tusamitamab ravtansine in NSQ NSCLC participants with negative or moderate CEACAM5 expression tumors and high circulating CEA
Excerpt:
...- Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.- Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (≥100 ng/mL). ...
Trial ID:
Source:
Title:
SAR408701 in combination with pembrolizumab and pembrolizumab alone in patients with non-squamous non-small cell lung cancer (NSQ NSCLC) A pembrolizumabbal kombinált SAR408701 és a pembrolizumab monoterápia összehasonlítása nem laphámsejtes, nem kissejtes tüdődaganatban szenvedő betegeknél (NSQ NSCLC)
Excerpt:
...-A CEACAM5 expressziója, amelyet prospektív módon bemutattak egy ≥2 + intenzitású, központilag értékelt IHC-teszttel, a tumorsejtpopuláció legalább 50%-ánál az archív tumormintában (vagy ha ez nem áll rendelkezésre, akkor friss biopsziás mintán). ...
Trial ID:
More C2 evidence
Source:
Title:
Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors
Excerpt:
...- Expression of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) will be assessed centrally using the most recent archival tumor tissue (or, if...
Trial ID:
Source:
Title:
Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Excerpt:
...- Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (≥100 ng/mL)....
Trial ID:
Source:
Title:
INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701
Excerpt:
...Intratumoral tusamitamab ravtansine concentration`Incidence of grade 3 or 4 adverse events`Response to treatment`CEACAM5 expression`RNA expression levels`circulating CEA levels`tumor genomic features`Maximal plasma concentration`AUCinf`AUClast`AUCt`Thalf`systemic tusamitamab ravtansine concentration`Volume of distribution`concentration DM4 metabolites: Lys-SPDB-DM4, Me-Dm4`features in tumor micro-environment...
Trial ID:
Source:
Title:
Evaluation of SAR408701 in Patients With Advanced Solid Tumors
Excerpt:
...Patient must consent to a baseline biopsy for retrospective confirmation of tumor CEACAM5 expression, except if NSCLC or SCLC without lesion amenable to biopsy....
Trial ID:
Source:
Title:
Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors
Excerpt:
...- At least 6 x 5 μm slides from formalin-fixed paraffin-embedded (FFPE) archival tissue should be available for retrospective central evaluation of CEACAM5 expression....
Trial ID:
Less C2 evidence
Source:
Title:
Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens
Published date:
08/28/2023
Excerpt:
Adults ages ≥18 years (range, 34-73) with locally advanced/metastatic solid tumors (N = 43...expressing/likely to express CEACAM5 received intravenous tusamitamab ravtansine...stable disease occurred in 35.7% of patients in Q2W-LD and 40.0% of patients in Q3W.
DOI:
10.1158/2767-9764.CRC-23-0284
Trial ID:
