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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03686124 | ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors | PHASE1 | RECRUITING | 375 | — | — | May 14, 2019 | Jun 1, 2032 | May 13, 2026 | 21 | United States, Germany |
Number of patients with dose-limiting toxicities (DLTs)
Treatment emergent adverse events (TEAEs), Adverse events of special interest (AESIs) and Treatment-emergent serious adverse events (TESAEs).
Objective response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) centrally assessed (by a BICR1) using RECIST1.1
| Arm | Type | Description |
|---|---|---|
| Dose Escalation A (closed to enrollment) | EXPERIMENTAL | Dose escalation of IMA203 |
| Extension Cohort A | EXPERIMENTAL | IMA203 at RP2D |
| Extension Cohort B (closed to enrollment) | EXPERIMENTAL | IMA203 at RP2D + nivolumab |
| Extension Cohort AA | EXPERIMENTAL | IMA203 at final RP2D (flat dose) |
| Uveal Melanoma | EXPERIMENTAL | IMA203 at RP2D |
| Dose Escalation B | EXPERIMENTAL | Dose escalation of IMA203CD8 |
| Extension Cohort C | EXPERIMENTAL | IMA203CD8 at dose levels confirmed to be safe |
| Extension Cohort D | EXPERIMENTAL | IMA203CD8 at dose levels confirmed to be safe; without IL-2 |
| Ovarian | EXPERIMENTAL | IMA203CD8 monotherapy at dose levels confirmed to be safe |
| Endometrial | EXPERIMENTAL | IMA203CD8 monotherapy at dose levels confirmed to be safe |
| Head and Neck, Lung, and Triple Negative Breast Cancer | EXPERIMENTAL | IMA203CD8 monotherapy at dose levels confirmed to be safe |
| Rare Cancers | EXPERIMENTAL | IMA203CD8 monotherapy at dose levels confirmed to be safe |
| Name | Type | Description |
|---|---|---|
| IMA203 Product | BIOLOGICAL | The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula |
| IMA203 product- flat dose | BIOLOGICAL | The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells |
| IMA203CD8 Product | BIOLOGICAL | The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula |
| Nivolumab | DRUG | Nivolumab will be given post IMA203/IMA203CD8 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb. |
| IMADetect® | DEVICE | IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in Immatics clinical trials. |
Inclusion Criteria: * Patients must have recurrent/progressing and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * HLA-A\*02:01 positive * For patients w...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520 / GEH200521 - Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | — | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |