Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-637 · 1 trial · 2 indications
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
ORR is defined as the percentage of participants with a confirmed response (CR) or partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1: ABBV-637 Monotherapy | EXPERIMENTAL | Participants will receive escalating doses of ABBV-637 in 28-day cycles. |
| Part 2a: ABBV-637 + Docetaxel | EXPERIMENTAL | Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles. |
| Part 2b: ABBV-637 + Docetaxel | EXPERIMENTAL | Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles. |
| Part 3a: ABBV-637 + Osimertinib | EXPERIMENTAL | Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles. |
| Part 3b: ABBV-637 + Osimertinib | EXPERIMENTAL | Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles. |
| Name | Type | Description |
|---|---|---|
| ABBV-637 | DRUG | Intravenous (IV) Infusion |
| Docetaxel | DRUG | Intravenous (IV) Infusion |
| Osimertinib | DRUG | Oral Tablets |
Inclusion Criteria: * Histologic solid tumor diagnosis (Part 1). * For Part 2 docetaxel combination therapy: EGFR WT expressing relapsed/refractory (R/R) non-small cell lung cancer (NSCLC) participants. * For Part 3 osimertinib combination therapy: mutEGFR-expressing RR NSCLC participants. * Measur...
ABBV-637 is an investigational therapy being studied in adults with relapsed or refractory advanced solid tumors, including non small cell lung cancer. It is being evaluated both as a single agent and in combination with intravenous docetaxel or osimertinib. It has not been approved for any use and remains in clinical development.
ABBV-637 is being developed by AbbVie Inc., the pharmaceutical company that trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the agent in advanced solid tumors.
ABBV-637 is in Phase 1 clinical development. The program consists of one active Phase 1 trial that is currently not recruiting, with no completed trials. As an investigational agent, ABBV-637 has not received FDA approval and is not available outside of clinical research.
ABBV-637 is being studied in the Phase 1 trial NCT04721015, titled a study of intravenous ABBV-637 alone or in combination with intravenous docetaxel or osimertinib in adults with relapsed or refractory solid tumors. The trial has enrolled 81 participants across the United States, Australia, France, Israel, Japan, South Korea, Spain, and Taiwan.
ABBV-637 is administered intravenously in its Phase 1 trial, either as a single agent or combined with intravenous docetaxel or osimertinib. The study enrolls adults aged 18 years and older of any sex and does not include healthy volunteers. It is a controlled trial without randomization or double blinding.
Yes, the ABBV-637 Phase 1 program is biomarker selected, meaning participants are enrolled based on specific molecular characteristics of their tumors rather than an unselected patient population. The trial NCT04721015 evaluates the agent in adults with relapsed or refractory advanced solid tumors, including non small cell lung cancer.