Autophagy Maintenance (AUTOMAIN)

NCT06971744 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 103919Pro00143653
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-institution, single-arm study with a safety lead-in to determine if previously established safe doses of autophagy drugs, hydroxychloroquine (HCQ) and nelfinavir mesylate (NFV) will benefit ovarian cancer patients in a maintenance setting. Patients will receive the two study drugs HCQ and NFV in combination with maintenance bevacizumab.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Safety of combination of study drugs

  To measure the safety of HCQ + NFV in combination with standard-of-care maintenance bevacizumab in patients with high-grade serous ovarian cancer. DLT (dose limiting toxicity) is the standard endpoint in evaluating safety at this study phase. Will monitor adverse events per CTCAE v5.0.

  6 months

• Evaluation of Anti Tumor Activity

  Evaluate the anti-tumor activity of HCQ + NFV in combination with standard-of-care maintenance bevacizumab in patients with high-grade serous ovarian cancer. Measured by 6-month progression-free survival rate, a composite metric based on CA 125 and radiographic imaging.

  6 months

Secondary Outcomes (2)

• Changes in CA125

  6 months

• Changes in Quality of Life

  6 months

Study Arms (1)

Hydroxychloroquine+Nelfinavir+Bevacizumab

EXPERIMENTAL

Subjects will take Hydroxychloroquine 3x 200 milligram tablets twice daily Subjects will take Nelfinavir 2x 625 milligram tablets twice daily Subjects will be administered Bevacizumab IV 15 milligram/kilogram every 3 weeks. DLT Period 21 Days (1 Cycle)

Drug: Hydroxychloroquine; Drug: Nelfinavir; Drug: Bevacizumab

Interventions

Hydroxychloroquine DRUG

3 x 200 milligram tablets twice daily

Hydroxychloroquine+Nelfinavir+Bevacizumab

Nelfinavir DRUG

2x 625 milligram tablets twice daily

Hydroxychloroquine+Nelfinavir+Bevacizumab

Bevacizumab DRUG

IV 15 milligram/kilogram every 3 weeks

Hydroxychloroquine+Nelfinavir+Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Participants must have platinum-sensitive first recurrent high-grade serous or high-grade predominantly serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Patients must have had a 6-month disease-free progression since last platinum chemotherapy to be considered platinum sensitive.
• All participants must agree to have previously undergone genetic testing with germline panel testing with at least BRCA 1/2 mutation status known and/or somatic tumor next generation sequencing with homologous recombination deficiency (HRD) testing and/or loss of heterozygosity (LOH) known.
• Participants must be enrolled within 3-8 weeks of the first day of the last cycle of platinum-based chemotherapy for their first cancer recurrence. - Participants must have received at least 3-courses of bevacizumab during chemotherapy and have a plan to continue maintenance bevacizumab therapy.
• Evidence of platinum-sensitive response to current platinum-based chemotherapy with a partial or complete response based on imaging or CA-125 trend
• Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin \[hCG\]) within 7 days before receiving the first dose of study treatment.
• Voluntary, signed, and dated, Institutional Review Board (IRB) approved consent form per regulatory and institutional guidelines.
• years of age or older.
• ECOG performance status of 0-2
• Bilirubin ≤ 1.5 times the upper limit of normal (ULN) and AST / ALT ≤ 3 times ULN. Subjects with Gilbert's syndrome may be included if the total bilirubin is \< 3 times ULN and the direct bilirubin is within normal limits.
• CrCl ≥35 mL/min, according to the Cockgroft-Gault formula.
• Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3.
• Platelet count ≥ 75,000 cells / mm3
• Hemoglobin ≥ 9 g/ dL, recent transfusion is allowed, though must be ≥ 7 days C1D1 of investigational agents
• Adequately controlled blood pressure (\<160 mm Hg/100 mm Hg) as determined by the treating investigator.
• Subjects with the potential to produce children must agree to effective contraceptive method use during study participation and at least 6 months after discontinuation of the study.

You may not qualify if:

• New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of ischemia on baseline ECG.
• Underlying psychiatric disorder requiring hospitalization within the last two years.
• Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.
• Platinum resistant or refractory disease
• Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.
• Treatment with local or systemic radiation therapy, surgery, or investigational therapy within 28 days before registration with the exception of the platinum doublet and bevacizumab.
• Unwillingness or inability to comply with procedures required in this protocol.
• Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.
• Patients who are receiving coumadin
• Patients who are currently participating in any other clinical trial of an investigational product.
• Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.
• Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled in this study.
• Female patients who are of child-bearing potential (WOCBP) who are pregnant or planning to become pregnant during the study or within 6 months of the last dose of study drugs. A urine pregnancy test for WOCBP will be collected during the screening period. Females will be determined not to be of child-bearing potential with a history of hysterectomy, tubal ligation, dual salpingo-oophorectomy, or age 45 or older with postmenopausal status \> 12 months.
• Patients unable to stop taking strong inhibitors and inducers of CYP2C8, CYP3A4, CYP2C19, CYP2D6, FMO-1, and MAO-A.
• Patients unable to stop taking substrates of CYP2D6, CYP3A4, P-gp, MATE1K, and MATE2K.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Hydroxychloroquine; Nelfinavir; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isoquinolines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Brian Orr

CONTACT

843-792-9300; orrb@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: May 14, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): June 18, 2028
• Study Completion (Estimated): June 18, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)