Therapy Detail
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| Therapy Name | M0324 + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| M0324 | M-0324|M 0324 | CD40 Antibody 16 MUC1 Antibody 8 | M0324 is a MUC1-conditional CD40 agonist comprising an antibody targeting MUC1 and two heavy-chain variable domains that bind to CD40, which potentially induces antitumor immune activity against MUC1-expressing tumors (Cancer Res (2025) 85 (8_Supplement_2): ND12). | |
| Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 132 | Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, in combination with chemoradiation for cervical cancer, and in combination with carboplatin and paclitaxel for endometrial carcinoma (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT07166601 | Phase I | M0324 + Pembrolizumab Fluorouracil + Irinotecan + Leucovorin + M0324 + Oxaliplatin M0324 | M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors (TITER) | Recruiting | USA | CAN | 1 |
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