Clinical trial NCT06730347: A Study of Lorigerlimab in Participants With Advanced Solid Tumors
Official title: A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Platinum-resistant Ovarian Cancer
Platinum-Resistant Fallopian Tube Carcinoma
Platinum-Resistant Primary Peritoneal Carcinoma
Clear Cell Adenocarcinoma of Ovary
Clear Cell Adenocarcinoma of Vulva
Clear Cell Adenocarcinoma of Vagina
Clear Cell Adenocarcinoma of Cervix
Clear Cell Adenocarcinoma of Uterus
Clear Cell Adenocarcinoma of Fallopian Tube
Clear Cell Adenocarcinoma of Peritoneum
Endometrial Cancer
Lead sponsor: MacroGenics
Sponsor class: INDUSTRY
First posted: 2024-12-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 60 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.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum based chemotherapy. OR
* Histologically confirmed clear cell ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval, or cervical cancer.
* Persistent or recurrent disease with documented disease progression.
* Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.
* Participants with CCGC must have received at least 1 prior line of therapy for CCGC.
* Participants with a known breast cancer (BRCA) mutation (germline or somatic) must have received a a Poly ADP-ribose polymerase (PARP) inhibitor, if locally approved and available, and experienced disease progression or intolerance on the PARP inhibitor.
* Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
* Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue, or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.
* Participants have acceptable physical condition and laboratory values.
* Participants of childbearing potential must agree to use highly effective methods of birth control.
* Participants must not be pregnant, planning to be pregnant, or breastfeeding.

Exclusion Criteria:

* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
* Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum- containing chemotherapy.
* Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1/PD-L1, anti-PD-L2, anti-CTLA-4).
* Active brain metastases or leptomeningeal metastases.
* Prior stem cell, tissue, or solid organ transplant.
* Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 3 years from first dose of study treatment. Participants with another tumor that has a negligible risk for metastasis or death such as, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast are eligible.

Primary outcomes:
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator
timeFrame: Throughout the study up to approximately 2 years
Secondary outcomes:
measure: Number of participants with adverse event (AEs), serious AEs (SAEs), and AEs leading to study treatment discontinuation.
timeFrame: Throughout the study, up to approximately 2 years
measure: Median duration of response (DoR) per RECIST 1.1 criteria
timeFrame: Throughout the study, up to approximately 2.5 years
measure: Median progression free survival (PFS) per RECIST 1.1 criteria
timeFrame: Throughout the study, up to 2.5 years
measure: Percent change from baseline in tumor size
timeFrame: Throughout the study, up to 2.5 years
measure: Best percent change from baseline in tumor size
timeFrame: Throughout the study, up to 2.5 years
measure: Disease control rate (DCR)
timeFrame: Throughout the study, up to 2.5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: New Orleans
country: United States
facility: Ochsner MD Anderson Cancer Center
state: Louisiana
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Pittsburgh
country: United States
facility: West Penn Allegheny Health
state: Pennsylvania
city: Houston
country: United States
facility: Mays Clinic
state: Texas
city: San Antonio
country: United States
facility: START San Antonio
state: Texas
city: Madison
country: United States
facility: Wisconsin Institute Medical Research- UW Cancer Connect
state: Wisconsin
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montréal
country: Canada
facility: McGill University
state: Quebec
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-Do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Hospital Bundang Hospital
state: Gyeonnggi-Do
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: MacroGenics
name: Pepi Pencheva
role: STUDY_DIRECTOR
References: