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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03893955 | A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 150 | — | — | May 21, 2019 | Mar 1, 2026 | Aug 12, 2025 | 26 | United States, Australia +4 |
ORR is defined as the percentage of participants with either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The RP2D of ABBV-927 + ABBV-368 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.
The RP2D of ABBV-927 + ABBV-368 + ABBV-181 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors | EXPERIMENTAL | Participants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927. |
| Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC | EXPERIMENTAL | Participants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181. |
| Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC | EXPERIMENTAL | Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV. |
| Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC | EXPERIMENTAL | Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV. |
| Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC | EXPERIMENTAL | Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV. |
| Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC | EXPERIMENTAL | Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV. |
| Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC | EXPERIMENTAL | Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV. |
| Name | Type | Description |
|---|---|---|
| ABBV-927 | DRUG | Intravenous (IV) Infusion |
| ABBV-368 | DRUG | Intravenous (IV) Infusion |
| ABBV-181 | DRUG | Intravenous (IV) Infusion |
| Carboplatin | DRUG | Intravenous (IV) Infusion |
| Nab-paclitaxel | DRUG | Intravenous (IV) Infusion |
Inclusion Criteria: * Adequate liver, kidney and hematology function as demonstrated by laboratory values detailed in the study protocol. * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Dose-Escalation: * Arm A: Participants with an advanced solid tumor who have progr...
| 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 |