Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100

NCT06065462 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2022-1047NCI-2023-07922
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if the combination of dostarlimab and LB-100 can help to control ovarian clear cell carcinoma

Conditions

Ovarian Clear Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year

Study Arms (1)

Dostarlimab + LB-100

EXPERIMENTAL

Dostarlimab will be given by vein over about 30 minutes on Day 1 of each cycle. LB-100 will be given by vein on Days 1-3 of each cycle. The first doses will be given over about 2 hours. After that, doses may be given over as little as 30 minutes.

Drug: Dostarlimab; Drug: LB-100

Interventions

Dostarlimab DRUG

Given by vein (IV)

Dostarlimab + LB-100

LB-100 DRUG

GIven by vein (IV)

Dostarlimab + LB-100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide signed informed consent
• Age 18-75 years at time of study entry
• Willingness and ability to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
• Histology showing recurrent clear cell ovarian, peritoneal, or fallopian tube cancer (mixed histology with predominant clear cell component is acceptable).
• Receipt of at least one prior line of therapy for recurrent disease or development of platinum resistant or refractory disease, defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment
• Available somatic mutation testing results (CLIA source) that reveal no PPP2R1A mutations
• Measurable disease based on modified RECIST v1.1. For the purposes of this study measurable disease is defined at least one "target lesion" that can be accurately measured in at least one dimension (longest dimension to be recorded). Each target lesion must be \>20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \>10 mm when measured by spiral CT. The target lesion must be distinct from other tumor areas selected for pre-treatment biopsies. Second lesion selected for pre-treatment biopsy must be biopsy accessible.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. See Section 14.
• Life expectantly of ≥12 weeks
• Adequate normal organ and bone marrow function as defined below.
• Hemoglobin ≥8.0 g/ dL
• Absolute neutrophil count (ANC) ≥ 1000/mm3
• Platelet count ≥100 x 109/L (\>100,000/mm3)
• Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
• AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5 x ULN

You may not qualify if:

• Participation in another clinical study with an investigational product (IP) during the last 28 days.
• Prior treatment with anti-CTLA-4 or anti-PDL-1/PD-1 antibodies.
• Patients with mismatch repair deficient (dMMR) by IHC or microsatellite instability-high tumors
• Concurrent treatment on another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
• Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤21 days prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of the agent, a longer wash-out period will be required, as agreed by study sponsors and the investigators.
• Subjects with Grade 2 neuropathy will be evaluated on a case-by-case basis after consultation with the principal investigator.
• Subjects with irreversible toxicity not reasonably expected to be exacerbated by the treatment with investigational therapy may be included only after consultation with the primary investigator.
• Any concurrent chemotherapy, immunotherapy, or hormonal therapy for cancer treatment.
• Major surgical procedure (defined by the investigator) within 28 days prior to the first dose of treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.
• History of allogenic or hematologic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis in the last 6 months (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome.
• a. The following exceptions to this criterion are listed below. i. Subjects with vitiligo or alopecia. ii. Subjects with hypothyroidism stable on hormone replacement. iii. Any chronic skin condition that does not require systemic therapy. iv. Subjects without active disease in the last 5 years may be included but only after consultation with the primary investigator.
• v. Subjects with celiac disease controlled by diet alone
• Uncontrolled intercurrent illness, including but not limited to: ongoing or active infection; symptomatic congestive heart failure; uncontrolled hypertension; unstable angina pectoris; cardiac arrythmia; interstitial lung disease; chronic obstructive pulmonary disease requiring systemic steroid therapy, oxygen, or hospitalization; serious chronic gastrointestinal conditions associated with diarrhea; or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
• Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of participant safety or study results.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• GSK Pharma: collaborator
• Lixte: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

dostarlimab; LB100

Study Officials

• Amir Jazaeri, M D

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ljiljana Milojevic

CONTACT

(713) 792-8578; lmilojev@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 4, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)