Acrivon Ther, ACR-368-201/GOG-3082,Ph1b/2,Open-label,Ovarian/endometrial/uroth,ACR-368+/-Gemcitabine

What is the Purpose of this Study?

Primary Arm 1 Assess the anti-tumor activity of ACR-368 monotherapy in each cohort (ovarian, endometrial, urothelial) of OncoSignature Positive subjects. Arm 2 Assess the safety and tolerability of ACR-368 in combination with LDG Determine the RP2D of LDG Secondary Arm 1 Confirmation of the OncoSignature thresholds for enrichment of ACR368 monotherapy responders. Assess safety and tolerability of ACR-368 monotherapy. Assess efficacy, disease control, survival, and landmarks of survival. Assess RDI every 2 months Assess the PK of ACR-368 in subjects with ovarian carcinoma Assess quality of life. Arm 2 Assess the anti-tumor activity of ACR-368 in combination with LDG Assess efficacy, disease control, survival, and landmarks of survival. Assess RDI every 2 months. Assess the PK of ACR-368 in combination with LDG.


Eligibility

  • 1. Participant must be able to give signed, written informed consent.
  • 2. Participant must have histologically confirmed, locally advanced (i.e., not amenable to curative surgery and/or radiation therapy) or metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
  • 3. Participant must have at least 1 measurable lesion per RECIST v1.1 criteria (by local Investigator) (Eisenhauer, 2009) in a baseline tumor imaging that has been obtained within 28 days of the treatment start. Participant must have radiographic evidence of disease progression based on RECIST v1.1 criteria following the most recent line of treatment. Biochemical recurrence (eg, cancer antigen \[CA-125\] in ovarian carcinoma) only is not considered as disease progression.
  • 4. Participant must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after written informed consent.
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Garrett Crook

More about this Clinical Trial

What is the full name of this clinical trial?

ACR-368-201/GOG-3082: A Phase 1b/2 Basket Study of Acr-368 as Monotherapy and in Combination With Gemcitabine in Adult Subjects With Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon Oncosignature ® Status

Study Details
Disease Type/Condition

Bladder cancer, Ovarian cancer, Uterine cancer

Principal Investigator

Rimel, Bobbie Jo

Co-Investigators

Edwin Posadas, Jun Gong, Kenneth Kim, Kristin Taylor, Margaret Liang

Age Group

Adult

Phase

I/II

IRB Number

STUDY00002636

ClinicalTrials.gov ID

NCT05548296

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Garrett Crook

Email
Garrett.Crook@cshs.org
Study Detail
Disease Type/Condition

Bladder cancer, Ovarian cancer, Uterine cancer

Principal Investigator

Rimel, Bobbie Jo

Age Group

Adult

Phase

I/II

IRB Number

ACR-368-201/GOG-3082

ClinicalTrials.gov ID

NCT05548296

Key Eligibility
ClinicalTrials.gov

Contact
Name

Garrett Crook

Email
Garrett.Crook@cshs.org