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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 being studied for the treatment of ovarian cancer in adults. It is an investigational small molecule therapeutic being developed by AbbVie Inc. as an oncology candidate. The clinical program is currently enrolling adult participants with ovarian cancer, including evaluation both as a single agent and in combination with other anticancer drugs.
ABBV-901 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the compound in ovarian cancer. The asset is an investigational small molecule in the company's oncology pipeline.
ABBV-901 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 program is currently recruiting participants and is designed to assess adverse events, changes in disease activity, and how the drug moves through the body.
ABBV-901 is being evaluated in one active clinical 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, France, Israel, Japan, Portugal, Spain, and Taiwan.
ABBV-901 is administered intravenously in its Phase 1 trial. The study evaluates intravenous ABBV901 both as a single agent and in combination with other anticancer drugs in adult participants with ovarian cancer. The trial is controlled and randomized, and it is enrolling participants aged 18 years and older regardless of sex.
The Phase 1 trial of ABBV-901, NCT07278336, plans to enroll 285 participants. It is a randomized, controlled study that is currently recruiting adults with ovarian cancer. Enrollment spans sites in the United States, Australia, France, Israel, Japan, Portugal, Spain, and Taiwan, and healthy volunteers are not eligible to participate.