ABBV-969 for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AbbVie

Must be taking: Novel hormonal agents

Disqualifiers: Other active malignancy, Interstitial lung disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy. ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 140 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves a new drug, it's possible that some medications might need to be adjusted. Please discuss this with the trial team for specific guidance.

Eligibility Criteria

This trial is for adults with metastatic castration-resistant prostate cancer. Participants will be given ABBV-969, an experimental drug, through IV infusion. The study aims to find the right dose and assess its safety and effectiveness over up to 3 years.

Inclusion Criteria

Estimated life expectancy > 6 months

Serum prostate specific antigen (PSA) level >= 1.0 ng/mL

Laboratory values meeting the criteria laid out in the protocol

+7 more

Exclusion Criteria

I have another active cancer besides the one being treated.

I have or had a lung condition not caused by known factors.

I have never needed steroids for lung inflammation nor show signs of it on a chest scan.

+2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ABBV-969 as a monotherapy to determine safety and pharmacokinetics

Up to 2 years

Regular visits at a hospital or clinic

Dose Expansion

Participants receive selected doses of ABBV-969 to determine the recommended Phase 2 dose

Up to 1 year

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

ABBV-969 is being tested in two parts: first, finding a safe dose by gradually increasing it (dose escalation), then giving multiple doses from part one randomly to determine the best dose for future studies (Phase 2).

3Treatment groups

Experimental Treatment

Group I: Part 2 B: ABBV-969 Dose ExpansionExperimental Treatment1 Intervention

Participants will receive dose B of ABBV-969 from part 1.

Group II: Part 2 A: ABBV-969 Dose ExpansionExperimental Treatment1 Intervention

Participants will receive dose A of ABBV-969 from part 1.

Group III: Part 1: ABBV-969 Dose EscalationExperimental Treatment1 Intervention

Participants will receive escalating doses of ABBV-969.