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LYT-200 · 2 trials · 8 indications
Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status.
Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status
PFS or ORR depending on tumor type
Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status
Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status
| Arm | Type | Description |
|---|---|---|
| Part 1 single agent dose escalation | EXPERIMENTAL | LYT-200 in metastatic solid tumors |
| Part 1 combination agents dose expansion | EXPERIMENTAL | LYT-200 in combination with chemotherapy or Tislelizumab in select metastatic solid tumors |
| Part 2 | EXPERIMENTAL | LYT-200 combination dose expansion in select metastatic solid tumors based on outcomes of Part 1 |
| Single agent dose escalation | EXPERIMENTAL | LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week. |
| Combination agent dose escalation | EXPERIMENTAL | LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week, in combination with oral venetoclax Day 1, 100 mg, Day 2, 200mg, Day 3-28, 400 mg and/or azacitidine, 75 mg/m2 subcutaneously given for 7 days per cycle or decitabine 20 mg/m2 IV for 5 days per cycle. |
| Name | Type | Description |
|---|---|---|
| LYT-200 | DRUG | monoclonal antibody (mAb), targeting galectin-9 protein |
| Tislelizumab | DRUG | anti-PD-1 monoclonal antibody |
| Gemcitabine/nab-paclitaxel | DRUG | chemotherapy |
| Venetoclax | DRUG | Bcl-2 inhibitor |
| Azacitidine | DRUG | Hypomethylating agent |
| Decitabine | DRUG | Hypomethylating agent |
Inclusion Criteria: Part 1 1. Written Informed Consent (mentally competent patient, able to understand and willing to sign the informed consent form) 2. Age ≥ 18 years, male or non-pregnant female 3. Able to comply with the study protocol, as per Investigator's judgment 4. Histologically confirmed...
Top 5 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | Durvalumab |
| Nanobiotix SA Sponsored ADR | NBTX | 1 | PHASE1 | NBTXR3 |
| Olema Pharmaceuticals, Inc. | OLMA | 1 | PHASE1 | OP-3136, Palazestrant |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
| Pfizer Inc. | PFE | 1 | N/A | Palbociclib |
LYT-200 is an investigational small molecule being studied in oncology for relapsed or refractory acute myeloid leukemia, high-risk myelodysplastic syndrome, and locally advanced or metastatic solid tumors, including pancreatic, urothelial, head and neck, and colorectal cancers. It has been tested both as a single agent and in combination with chemotherapy or tislelizumab.
LYT-200 is being developed by PureTech Health plc, which trades under the ticker PRTCY. The company has sponsored Phase 1 and Phase 1/2 clinical studies of the candidate in hematologic malignancies and advanced solid tumors conducted in the United States.
LYT-200 is in Phase 1 clinical development. It has been evaluated in a Phase 1 study in relapsed or refractory AML and high-risk MDS and in a Phase 1/Phase 2 study in advanced solid tumors. LYT-200 is investigational and is not approved for any indication.
LYT-200 has been studied in two completed trials. NCT05829226 was a Phase 1 study in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome with 101 participants. NCT04666688 was a Phase 1/Phase 2 study of LYT-200 alone and with chemotherapy or tislelizumab in advanced solid tumors with 44 participants.
LYT-200 has been studied in relapsed or refractory acute myeloid leukemia, high-risk myelodysplastic syndrome, and advanced solid tumors. The solid tumor study enrolled patients with metastatic cancer, pancreatic cancer, urothelial carcinoma, head and neck cancer, and colorectal cancer, testing LYT-200 alone and combined with chemotherapy or tislelizumab.