Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06242691 | Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002) | PHASE1 | COMPLETED | 13 | — | — | Feb 28, 2024 | Jun 17, 2025 | Jun 5, 2026 | 16 | United States, Australia +4 |
The occurrence of any of the following toxicities within 28 days after the first dose of study intervention were considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration: * Grade 4 nonhematologic toxicity (not laboratory). Any nonhematologic AE ≥Grade 3 in severity was considered a DLT, with pre-specified exceptions * Any Grade 3 or Grade 4 laboratory value (hematologic or nonhematologic), with pre-specified exceptions * Febrile neutropenia Grade 3 or Grade 4 as prespecified by the protocol * Prolonged delay (\>2 weeks) in initiating Cycle 2 due to intervention-related toxicity * Any intervention-related toxicity that caused the participant to discontinue intervention during Cycle 1 * Missed \>25% of MK-1200 doses as a result of drug-related AEs during the first cycle * Grade 5 toxicity
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE is reported for each arm.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study intervention due to an AE is reported for each arm.
| Arm | Type | Description |
|---|---|---|
| Part 1: MK-1200 | EXPERIMENTAL | In Part 1, participants will receive escalating doses of MK-1200 via intravenous (IV) infusion every 2 weeks (Q2W) until any discontinuation criteria are met. |
| Part 2: MK-1200 Cohort A | EXPERIMENTAL | In Part 2, participants in Cohort A will receive either Dose 1 or Dose 2 of MK-1200 (determined from Part 1) via IV infusion Q2W until any discontinuation criteria are met. |
| Part 2: MK-1200 Cohort B | EXPERIMENTAL | In Part 2, participants in Cohort B will receive Dose 1 of MK-1200 (determined from Part 1) via IV infusion Q2W until any discontinuation criteria are met. |
| Name | Type | Description |
|---|---|---|
| MK-1200 | BIOLOGICAL | IV Infusion |
| Antiemetic | DRUG | One or more prophylactic antiemetic(s) (e.g. 5-HT3 receptor antagonists, dexamethasone, neurokinin-1 receptor antagonists, etc.) may be selected based on previous response of participants to antiemetic medications and individual factors, and will be administered per approved product label prior to MK-1200 infusion |
Inclusion Criteria: * Confirmed advanced (unresectable and/or metastatic) solid tumor: gastric cancer (including gastroesophageal junction cancer), esophageal cancer, biliary tract cancer, or pancreatic ductal adenocarcinoma * Participants who experienced Adverse Events (AEs) due to previous antica...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |