A Phase 1 interventional study of ABBV-637 and Docetaxel in Advanced Solid Tumors Cancer and Non Small Cell Lung Cancer (NSCLC), sponsored by AbbVie. Active, not recruiting at 33 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed.
ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world.
In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 81 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive escalating doses of ABBV-637 in 28-day cycles.
Drug: ABBV-637
Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles.
Drug: ABBV-637 · Drug: Docetaxel
Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles.
Drug: ABBV-637 · Drug: Docetaxel
Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles.
Drug: ABBV-637 · Drug: Osimertinib
Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles.
Drug: ABBV-637 · Drug: Osimertinib
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Oral Tablets
Number of Participants Experiencing Adverse Events (AEs)
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.
Time frame: Up to approximately 3 years
Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3)
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.
Time frame: Up to approximately 3 years
Percentage of Participants With Objective Response Rate (ORR) (Part 1)
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.
Time frame: Up to approximately 3 years
Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1)
DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.
Time frame: Up to approximately 12 months
Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.
Time frame: Up to approximately 20 months
Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
PFS is defined as the time from the first dose of any study drug to a documented radiographic disease progression according to RECIST version 1.1 as determined by the investigator, clinical progression or death from any cause, whichever occurs earlier.
Time frame: Up to approximately 20 months
Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
OS is defined as the time from the first dose of any study drug until death from any cause.
Time frame: Up to approximately 12 months after last dose of study drug
Plan to share: No
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Carcinoma, Non-Small-Cell Lung→
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