Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-927 · 2 trials · 6 indications
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.
The MTD and the RPTD of ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Once the RPTD has been determined, the dose expansion portion will begin.
Time to Cmax (Tmax) of ABBV-927.
Maximum observed serum concentration (Cmax) of ABBV-927.
Terminal-phase elimination rate constant (β)of ABBV-927.
Terminal half-life (t1/2) of ABBV-927.
Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-927.
Time to Cmax (Tmax) of ABBV-181.
Maximum observed serum concentration (Cmax) of ABBV-181.
Terminal-phase elimination rate constant (β)of ABBV-181.
Terminal half-life (t1/2) of ABBV-181.
Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-181.
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
| 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. |
| Escalating Arm 1: ABBV-927 | EXPERIMENTAL | Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927. |
| Escalating Arm 2: ABBV-927 | EXPERIMENTAL | Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927. |
| Escalating Arm 3: ABBV-927+ABBV-181 | EXPERIMENTAL | Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181. |
| Escalating Arm 4: ABBV-927+ABBV-181 | EXPERIMENTAL | Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181. |
| Escalating Arm 5 (Japan): ABBV-927 | EXPERIMENTAL | Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927. |
| Escalating Arm 6 (Japan): ABBV-927+ABBV-181 | EXPERIMENTAL | Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181. |
| Expansion Arm A: ABBV-927 | EXPERIMENTAL | Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927. |
| Expansion Arm B: ABBV-927+ABBV-181 | EXPERIMENTAL | Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181. |
| Expansion Arm C: ABBV-927+ABBV-181 | EXPERIMENTAL | Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181. |
| 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...
ABBV-927 is an investigational small molecule being studied for the treatment of advanced solid tumors and cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.
ABBV-927 targets CD40, a protein involved in immune system regulation. By targeting CD40, the drug is designed to modulate immune responses, which may help in fighting cancer. This mechanism is being explored in the context of advanced solid tumors.
ABBV-927 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
ABBV-927 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trials are focused on assessing safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
ABBV-927 is being studied in two Phase 1 clinical trials. The first, NCT02988960, evaluates ABBV-927 in combination with ABBV-181 in participants with advanced solid tumors. The second, NCT03893955, studies ABBV-927 with ABBV-368, budigalimab, and/or chemotherapy in patients with locally advanced or metastatic solid tumors.
No, ABBV-927 and ABBV-181 are different drugs. ABBV-927 targets CD40, while ABBV-181, also known as budigalimab, is an immunotherapy agent. They are being studied together in combination for the treatment of advanced solid tumors, but they are distinct investigational compounds.