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ABBV-901 · 1 trial · 1 indication
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 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 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 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. |
| 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. |
| Part 5: ABBV-901 + Carboplatin + Bevacizumab Escalation | EXPERIMENTAL | Participants will receive escalating doses of ABBV-901 in combination with Carboplatin \& Bevacizumab, as part of the approximately 3 year study duration. |
| Part 6: ABBV-901 + Carboplatin + Bevacizumab Expansion | EXPERIMENTAL | Participants will receive the recommended doses for expansion doses of ABBV-901 in combination with Carboplatin \& Bevacizumab, as part of the approximately 3 year study duration. |
| Name | Type | Description |
|---|---|---|
| ABBV-901 | DRUG | Intravenous (IV) |
| Bevacizumab | DRUG | Intravenous (IV) |
| Carboplatin | DRUG | Intravenous (IV) |
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 enrolled in back...
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ABBV-901 is an investigational small molecule developed by AbbVie Inc. (ticker ABBV) for the treatment of ovarian cancer. It is in Phase 1 clinical development and is being studied both as a single agent and in combination with other anticancer drugs in adult participants.
ABBV-901 is being evaluated for the treatment of ovarian cancer in adults. The Phase 1 study assesses adverse events, changes in disease activity, and how intravenous ABBV-901 moves through the body when given alone or in combination with other anticancer drugs.
ABBV-901 is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the small molecule in ovarian cancer.
ABBV-901 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single registered trial is currently recruiting adult participants with ovarian cancer.
ABBV-901 is being studied in one Phase 1 trial, NCT07278336, titled a study to assess adverse events, change in disease activity, and how intravenous ABBV901 moves through the body alone or in combination with other anticancer drugs in adult participants with ovarian cancer. The trial is recruiting and plans to enroll 285 participants across the United States, Australia, Israel, Japan, Portugal, Spain, and Taiwan.