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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05957081 | Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309 | PHASE1 | RECRUITING | 67 | — | — | Jan 3, 2024 | Apr 30, 2030 | Dec 30, 2025 | 4 | Australia |
Vital signs will be assessed by changes in systolic/diastolic blood pressure, respiratory rate, body temperature and heart rate.
A complete physical examinations of general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
The following ECG parameters will be recorded: heart rate, RR interval, HR interval, QTc interval, and QRS interval.
Laboratory results will include biochemistry, Thyroid function test, hematology, coagulation and urinalysis
Adverse events includes \[treatment-emergent AE, serious AEs, treatment-emergent AEs of special interest\] which will be coded using most current version of MedDRA.
MTD of PMC-309 will be calculated by incidence of DLT at 21 days from the first dosing of PMC 309.
MTD of PMC-309 by incidence of DLT at 21 days from the first dosing of PMC-309 in combination with pembrolizumab.
| Arm | Type | Description |
|---|---|---|
| Phase 1 a: Part A: PMC-309 Monotherapy Dose Escalation | EXPERIMENTAL | Phase 1a will enroll participants with advanced or metastatic solid tumors to assess safety, tolerability, PK and clinical efficacy in response to treatment with PMC-309 as a monotherapy Dosage form and Route of administration: The duration of a treatment cycle is 3 weeks/21 days. Participants will be administered a weekly dose of PMC-309 per cycle as follows: * Cycle Week 1/Day 1 * Cycle Week 2/Day 8 ± 2 days * Cycle Week 3/Day 15 ± 2 days PMC-309 will be administered intravenously over 1 hour (± 0.5 hours), after which participants will be observed for a period of 1.5 hours post administration. |
| Phase 1a: Part B: PMC-309 Dose Escalation in Combination with Pembrolizumab | EXPERIMENTAL | Part B will establish the MTD/preliminary RP2D of PMC-309 when administered in combination with 200 mg pembrolizumab. Part B will be conducted after completion of Part A (PMC-309 monotherapy dose escalation) and before the commencement of Phase 1b. Dosage form and Route of administration: The duration of a treatment cycle is 3 weeks/21 days. Participants will be administered a weekly dose of PMC-309 plus one dose of pembrolizumab at 200 mg per cycle as follows: * Cycle Week 1/Day 1: pembrolizumab (administered first), followed by administration of PMC-309. * Cycle Week 2/Day 8 ± 2 days: PMC-309 only * Cycle Week 3/Day 15 ± 2 days: PMC-309 only. Both PMC-309 and pembrolizumab will be administered intravenously. |
| Phase 1b: Dose Expansion | EXPERIMENTAL | Phase 1b will enroll participants after completion of DLT assessments for Phase 1a. Phase 1b will enroll participants with advanced or metastatic tumor types into 1 of 2 cohorts to assess response of monotherapy of PMC-309 and response of PMC-309 in combination with pembrolizumab. * Cohort A: PMC-309 monotherapy therapy \- PMC-309 dosing will be at the preliminary RP2D, as identified in Phase 1a: Part A * Cohort B: PMC-309 plus pembrolizumab combination therapy - PMC-309 dosing will be as identified in Phase 1a: Part B in combination with 200 mg pembrolizumab Participants will be randomly assigned to Cohort A or Cohort B until 20 participants are enrolled in each cohort. |
| Name | Type | Description |
|---|---|---|
| PMC-309 monotherapy | DRUG | PMC-309 will be administered intravenously. |
| PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®) | DRUG | Both PMC-309 and pembrolizumab will be administered intravenously. At the time of the combination therapy (Week 1/Day 1 of each cycle), participants will be dosed with pembrolizumab(KEYTRUDA®) first, administered over 0.5 hours (± 10 minutes). Following an interval of 1 hour (± 15 minutes), participants will be dosed with PMC-309 administered over 1 hour (± 0.5 hours), after which participants will be observed for a period of 1.5 hours post administration. |
| PMC-309 Dose Expansion | DRUG | Phase 1b will enroll participants with advanced or metastatic tumor types into 1 of 2 cohorts: * Cohort A: PMC-309 monotherapy therapy \- PMC-309 dosing will be at the preliminary RP2D, as identified in Phase 1a: Part A * Cohort B: PMC-309 plus pembrolizumab(KEYTRUDA®) combination therapy - PMC-309 dosing will be as identified in Phase 1a: Part B in combination with 200 mg pembrolizumab(KEYTRUDA®) |
Inclusion Criteria: To be eligible for this study, a participant must meet ALL of the following inclusion criteria: 1. The participant voluntarily signs an informed consent form (ICF) indicating they understand the purpose and procedures required for the study and are willing to participate in the...
| 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 |