Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • 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

    Cancer Categories
    • Gynecologic
    Karmanos Trial ID
    • GOG-3082
    NCT ID
    • NCT05548296
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator
    • Ira
      Winer, M.D., Ph.D., FACOG

      Oncology - Gynecologic, Oncology - Surgical View Profile

    Objective:

    Primary Objectives:

    Phase 2 Simon 2-Stage Study (Arm 1 Monotherapy)

    • Assess the anti-tumor activity of
      ACR-368 monotherapy in each cohort
      (ovarian, endometrial, urothelial) of
      OncoSignature Positive subjects.

    Phase 1b (Arm 2 Combination Therapy)

    • Assess the safety and tolerability of
      ACR-368 in combination with LDG.
    • Determine the RP2D of LDG

    Phase 2 Exploratory Study (Arm 2 Combination Therapy)

    • Assess the anti-tumor activity of
      ACR-368 in combination with LDG in
      each cohort (ovarian, endometrial,
      urothelial) of OncoSignature Negative
      subjects.

    Secondary Objectives:

    Phase 2 Simon 2-Stage Study (Arm 1 Monotherapy)

    • Confirmation of the OncoSignature
      thresholds for enrichment of ACR-368
      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.

    Phase 1b Study (Arm 2 Combination Therapy)

    • 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.

    Phase 2 Exploratory Study (Arm 2 Combination Therapy)

    • Assess safety and tolerability of
      ACR-368 in combination with the
      RP2D of LDG.
    • Assess efficacy, disease control,
      survival, and landmarks of survival
    • Assess RDI every 2 months.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions
    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
    Get Directions
    Phone: 800-527-6266