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 small molecule being developed for the treatment of advanced solid tumors, including non-small cell lung cancer (NSCLC). It is currently being studied in adult participants with relapsed or refractory solid tumors, either alone or in combination with other therapies.
ABBV-637 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.
ABBV-637 is currently in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is assessing the drug's safety, tolerability, and preliminary efficacy in adult participants with relapsed or refractory solid tumors.
ABBV-637 is being studied in a Phase 1 clinical trial registered as NCT04721015. This trial evaluates ABBV-637 alone or in combination with docetaxel or osimertinib in adult participants with relapsed or refractory solid tumors, including non-small cell lung cancer. The study is active but not recruiting participants.
ABBV-637 is a unique investigational compound developed by AbbVie. It is not known to be the same as any other approved or marketed drug. Its chemical structure and mechanism of action are distinct, and it is being studied specifically for its potential role in treating advanced solid tumors.