Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522209-40-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Ovarian cancer (OC) is a lethal disease. The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABBV901, alone or in combination with bevacizumab, in participants with ovarian cancer.
ABBV901 is an investigational drug for the treatment of ovarian cancer. This study has 4 Parts (Arms) where participants will receive ABBV-901, alone or in combination with the standard available therapy, bevacizumab. Around 219 participants will be enrolled in the study at approximately 75 sites around the world.
In part 1, participants will receive escalating doses of intravenous (IV) ABBV-901 alone. In part 2, participants will receive 1 of 3 doses of IV ABBV-901, alone to determine the optimized dose. In part 3, participants will receive escalating doses of IV ABBV-901, combination with IV bevacizumab. In part 4, participants will receive recommended doses for expansion of IV ABBV-901, combination with IV bevacizumab. The total study duration will be approximately 3 years.
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 and may require frequent medical assessments, blood tests, and scans.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: ABBV-901 Dose Escalation | Experimental | Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration. |
|
| Part 2: ABBV-901 Optimization/Expansion Dose A | Experimental | Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration. |
|
| Part 2: ABBV-901 Optimization/Expansion Dose B | Experimental | Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration. |
|
| Part 2: ABBV-901 Optimization/Expansion Dose C | Experimental | Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration. |
|
| Part 3: ABBV-901 + Bevacizumab Escalation | Experimental | Participants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-901 | Drug | Intravenous (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AE) | 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. | Up to Approximately 3 Years |
| Overall Response | Overall response is defined as participants achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as assessed by the investigator. | Up to Approximately 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST Version 1.1 criteria to disease progression or death of any cause, whichever occurs earlier. | Up to Approximately 3 Years |
Not provided
Inclusion Criteria:
Diagnosis of an advanced or unresectable malignant high grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC), fallopian tube or primary peritoneal cancer by histology (World Health Organization [WHO] criteria).
Participants must be considered platinum resistant or platinum ineligible. Platinum resistant disease is defined as radiographic progression within 6 months (up to 182 days) after the last dose of the most recent platinum therapy).
Prior anticancer therapy:
For participants enrolled in backfill, subjects must provide consent to paired biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute at HealthONE /ID# 278785 | Recruiting | Denver | Colorado | 80218 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Part 4: ABBV-901 + Bevacizumab Expansion | Experimental | Participants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration. |
|
| Bevacizumab | Drug | IV |
|
| Progression-free survival (PFS) |
PFS is defined as time from first study treatment to a documented disease progression according to RECIST Version 1.1 (or other assessment criteria), as determined by the investigator, or death due to any cause, whichever occurs earlier. |
| Up to Approximately 3 Years |
| Overall Survival (OS) | OS is defined as time from first study treatment to death due to any cause. | Up to Approximately 3 Years |
| Disease Control Rate | Disease Control Rate is defined as the percentage of participants with best overall response (BOR) of stable disease (SD), PR or better per investigator review according to RECIST version 1.1 criteria. | Up to Approximately 3 Years |
| University of Chicago Medical Center /ID# 278295 |
| Recruiting |
| Chicago |
| Illinois |
| 60637 |
| United States |
| NEXT Oncology - San Antonio /ID# 278606 | Recruiting | San Antonio | Texas | 78229 | United States |
| Start Mountain Region /ID# 278609 | Recruiting | West Valley City | Utah | 84119 | United States |
| Next Virginia /ID# 278607 | Recruiting | Fairfax | Virginia | 22031 | United States |
| Sun Yat-Sen University Cancer Center /ID# 282505 | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
| Qilu Hospital Of Shandong University /ID# 283564 | Not yet recruiting | Jinan | Shandong | 250014 | China |
| Shandong Cancer Hospital /ID# 283566 | Not yet recruiting | Jinan | Shandong | 250117 | China |
| Fudan University Shanghai Cancer Center /ID# 282600 | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| The Chaim Sheba Medical Center /ID# 278416 | Recruiting | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Rambam Health Care Campus /ID# 278418 | Recruiting | Haifa | 3109601 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 278420 | Recruiting | Jerusalem | 91120 | Israel |
| National Cancer Center Hospital East /ID# 278604 | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Saitama Medical University International Medical Center /ID# 278437 | Recruiting | Hidaka | Saitama | 350-1298 | Japan |
| Shizuoka Cancer Center /ID# 278538 | Recruiting | Sunto-gun | Shizuoka | 411-8777 | Japan |
| New Zealand Clinical Research (Christchurch) /ID# 281467 | Not yet recruiting | Christchurch | Canterbury | 8011 | New Zealand |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided