A Study of Lorigerlimab in Participants With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
MacroGenics
Study ID
NCT06730347
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clear Cell Adenocarcinoma of Cervix
  • Clear Cell Adenocarcinoma of Fallopian Tube
  • Clear Cell Adenocarcinoma of Ovary
  • Clear Cell Adenocarcinoma of Peritoneum
  • Clear Cell Adenocarcinoma of Uterus
  • Clear Cell Adenocarcinoma of Vagina
  • Clear Cell Adenocarcinoma of Vulva
  • Endometrial Cancer
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Platinum-resistant Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lorigerlimab — BIOLOGICAL
    Bispecific DART protein binding PD-1 and CTLA-4

Study Details

Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 80 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC. Participants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends. Participants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.

Key Dates

Start date
May 1, 2025
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (PROC) high dose
    Lorigerlimab 6 mg/kg IV every 21 days
  • Experimental: Cohort A (PROC) low dose
    Lorigerlimab 3 mg/kg IV every 21 days
  • Experimental: Cohort B (CCGC)
    Lorigerlimab 6 mg/kg IV every 21 days
  • Experimental: Cohort C (CCGC)
    Lorigerlimab 3 mg/kg IV every 21 days

Primary Outcome Measure

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator [ Time Frame: Throughout the study up to approximately 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095
Surya Nagesh
Salani Ritu, MD (PRINCIPAL_INVESTIGATOR)
Ochsner MD Anderson Cancer CenterNew OrleansLouisiana70115
Chad Hamilton
Chad Hamilton, MD (PRINCIPAL_INVESTIGATOR)
START MidwestGrand RapidsMichigan49546
Judy Phan
Manish Sharma, MD (PRINCIPAL_INVESTIGATOR)
West Penn Allegheny HealthPittsburghPennsylvania15224
Sarah Crafton
Sarah Crafton, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer Center, Gynecologic Oncology CenterHoustonTexas77030
Mariana Gallardo
Amir Jazaeri, MD (PRINCIPAL_INVESTIGATOR)
START San AntonioSan AntonioTexas78229
Alison Procter
Drew Rasco, MD (PRINCIPAL_INVESTIGATOR)
Wisconsin Institute Medical Research- UW Cancer ConnectMadisonWisconsin53705
Claire Kostechka
Janelle Sobecki, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

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By specialty
OncologyGynecologic oncologyWomen's health
By research site
UCLA· Los Angeles, CAOchsner MD Anderson Cancer Center· New Orleans, LASTART Midwest· Grand Rapids, MIWest Penn Allegheny Health· Pittsburgh, PAThe University of Texas MD Anderson Cancer Center, Gynecologic Oncology Center· Houston, TXSTART San Antonio· San Antonio, TX

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