Advanced Solid Tumors CancerPhase 1NCT04721015
Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors
A Phase 1 study testing ABBV-637, Docetaxel and Osimertinib in people with Advanced Solid Tumors Cancer and Non Small Cell Lung Cancer (NSCLC), run by AbbVie at 33 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors Cancer, Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- ABBV-637, Docetaxel and Osimertinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 33 sitesin 8 countries
- Study dates
- 23 Feb 2021to Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- For Part 1 only - history of R/R disease that has progressed on all standard of care therapy.
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- For Part 2 only - history of RR NSCLC that has progressed after treatment with platinum-based chemotherapy regimen and either immune checkpoint inhibitor or targeted therapy and may not have been treated with prior single agent chemotherapy.
- For Part 3 only - history of RR NSCLC that has progressed on osimertinib
- Meet the laboratory values as described in the protocol.
Who cannot join
- History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
- Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
- For Part 3 only: History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
Trial locations and contacts
33 sites in 8 countries.
33 sites in 8 countries
United States6 sites
Dana-Farber Cancer Institute /ID# 231209
Boston, Massachusetts, 02215
Virginia Cancer Specialists - Fairfax /ID# 225693
Fairfax, Virginia, 22031
Carolina BioOncology Institute /ID# 225358
Huntersville, North Carolina, 28078
Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145
Providence, Rhode Island, 02903-4923
South Texas Accelerated Research Therapeutics /ID# 225359
San Antonio, Texas, 78229
Washington University-School of Medicine /ID# 225698
St Louis, Missouri, 63110
France5 sites
Institut Bergonie /ID# 225778
Bordeaux, Gironde, 33000
Centre Georges François Leclerc /ID# 226760
Dijon, 21079
AP-HM - Hopital de la Timone /ID# 225779
Marseille, Bouches-du-Rhone, 13385
Institut Curie /ID# 225829
Paris, Paris, 75248
Institut Claudius Regaud /ID# 225780
Toulouse, 31052
Japan5 sites
National Cancer Center Hospital /ID# 225724
Chuo-ku, Tokyo, 104-0045
National Hospital Organization Kyushu Cancer Center /ID# 240761
Fukuoka, Fukuoka, 811-1395
National Cancer Center Hospital East /ID# 225725
Kashiwa-shi, Chiba, 277-8577
Duplicate_National Hospital Organization Shikoku Cancer Center /ID# 240821
Matsuyama, Ehime, 791-0280
NHO Nagoya Medical Center /ID# 244412
Nagoya, Aichi-ken, 460-0001
Spain5 sites
Hospital Universitario Vall d'Hebron /ID# 225976
Barcelona, Barcelona, 08035
Hospital Universitario Fundacion Jimenez Diaz /ID# 225975
Madrid, Madrid, 28040
Hospital Universitario 12 de Octubre /ID# 225977
Madrid, Madrid, 28041
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 226096
Majadahonda, Madrid, 28222
Hospital Universitario Virgen de la Victoria /ID# 225978
Málaga, Malaga, 29010
South Korea4 sites
National Cancer Center /ID# 231887
Goyang-si, Gyeonggido, 10408
Asan Medical Center /ID# 231886
Seoul, Seoul Teugbyeolsi, 05505
Samsung Medical Center /ID# 231888
Seoul, Seoul Teugbyeolsi, 06351
Yonsei University Health System Severance Hospital /ID# 233774
Seoul, 03722
Taiwan4 sites
National Taiwan University Hospital - Hsinchu branch /ID# 243610
Hsinchu, 30059
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 243345
Kaohsiung City, Kaohsiung, 807
National Cheng Kung University Hospital /ID# 225944
Tainan, Tainan, 704
Linkou Chang Gung Memorial Hospital /ID# 225946
Taoyuan City, 333
Australia2 sites
Austin Health /ID# 225638
Heidelberg, Victoria, 3084
Wollongong Hospital /ID# 228350
Wollongong, New South Wales, 2500
Israel2 sites
Rambam Health Care Campus /ID# 225586
Haifa, H_efa, 3109601
The Chaim Sheba Medical Center /ID# 225585
Ramat Gan, Tel Aviv, 5265601
About this study
Official title: A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors
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.
Read more
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.
- Being tested
- ABBV-637, Docetaxel, Osimertinib
- Keywords
- Advanced Solid Tumors Cancer, Non Small Cell Lung Cancer, NSCLC, Cancer, ABBV-637, Docetaxel, Osimertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-637Drug
Intravenous (IV) Infusion
DocetaxelDrug
Intravenous (IV) Infusion
OsimertinibDrug
Oral Tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ABBV-637 Monotherapy | Experimental | Participants will receive escalating doses of ABBV-637 in 28-day cycles. Receives: Drug: ABBV-637 |
| Part 2a: ABBV-637 + Docetaxel | Experimental | Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles. Receives: Drug: ABBV-637; Drug: Docetaxel |
| 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. Receives: Drug: ABBV-637; Drug: Docetaxel |
| Part 3a: ABBV-637 + Osimertinib | Experimental | Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles. Receives: Drug: ABBV-637; Drug: Osimertinib |
| 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. Receives: Drug: ABBV-637; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to approximately 3 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 12 months after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start23 Feb 2021
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721015
- Sponsor's protocol ID
- M20-111
- Other IDs
- 2020-004953-57
- Status last verified
- Jun 2025
- First submitted
- 20 Jan 2021
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT04721015
- Acronym / sponsor ID
- M20-111
- Keywords
- Advanced Solid Tumors Cancer, Non Small Cell Lung Cancer, NSCLC, Cancer, ABBV-637, Docetaxel, Osimertinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: ABBV-637 Monotherapy | Experimental | Drug: ABBV-637Participants will receive escalating doses of ABBV-637 in 28-day cycles. |
| Part 2a: ABBV-637 + Docetaxel | Experimental | Drug: ABBV-637, Drug: DocetaxelParticipants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles. |
| Part 2b: ABBV-637 + Docetaxel | Experimental | Drug: ABBV-637, Drug: DocetaxelParticipants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles. |
| Part 3a: ABBV-637 + Osimertinib | Experimental | Drug: ABBV-637, Drug: OsimertinibParticipants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles. |
| Part 3b: ABBV-637 + Osimertinib | Experimental | Drug: ABBV-637, Drug: OsimertinibParticipants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Key exclusion criteria (3 listed)
- History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
- Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
- For Part 3 only: History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-637Intravenous (IV) Infusion | Drug | Part 1: ABBV-637 Monotherapy, Part 2a: ABBV-637 + Docetaxel, Part 2b: ABBV-637 + Docetaxel, Part 3a: ABBV-637 + Osimertinib, Part 3b: ABBV-637 + Osimertinib |
| DocetaxelIntravenous (IV) Infusion | Drug | Part 2a: ABBV-637 + Docetaxel, Part 2b: ABBV-637 + Docetaxel |
| OsimertinibOral Tablets | Drug | Part 3a: ABBV-637 + Osimertinib, Part 3b: ABBV-637 + Osimertinib |
Primary outcome
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to approximately 3 years
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.
Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3)
Time frame: Up to approximately 3 years
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.
5 secondary outcomes
Percentage of Participants With Objective Response Rate (ORR) (Part 1)
Time frame: Up to approximately 3 years
Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1)
Time frame: Up to approximately 12 months
Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
Time frame: Up to approximately 20 months
Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
Time frame: Up to approximately 20 months
Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
Time frame: Up to approximately 12 months after last dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
33 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-637, Docetaxel and Osimertinib in people with Advanced Solid Tumors Cancer and Non Small Cell Lung Cancer (NSCLC), run by AbbVie at 33 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, France, Japan, Spain, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.