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Dose Escalation; Intervention: Drug: STAR0602

Dose Expansion; Recommended Phase 2 Dose (RP2D) identified from Phase 1 will be used in Phase 2; Intervention: Drug: STAR0602

STAR0602

Ke Liu, MD, PhD

Guru Sonpavde, MD

Marijo Billusic, MD

Erica Redmond

James Gulley, MD, PhD

Ryan Sullivan, MD

Claire Friedman, MD

Kai He, MD

Lillian Siu, MD

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

This Phase 1/2 study consists of two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1 Dose Escalation, STAR0602 will be administered intravenously in participants with advanced solid tumors to assess safety/tolerability profile of STAR0602 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of STAR0602. In Phase 2 Dose Expansion, STAR0602 at RP2D will be administered to participants with advanced, antigen-rich solid tumors to further evaluate safety and assess preliminary clinical activity of STAR0602. Clinical activity will be evaluated by objective tumor response rate (ORR), duration of response (DOR), disease control rate (DCR), and progression free survival (PFS).

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

Complete response (CR) and partial response (PR)

Marengo Therapeutics, Inc.

Wounds and Injuries

Vaginitis

Precancerous Conditions

Vulvovaginitis

Vaginal Diseases

vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida

vaginitis panel

Rachel Lacy

Primary:

* To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
* To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.

Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions

To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision

To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease

University of Virginia

Principal Investigator

Carcinoma in Situ

Uterine Cervical Dysplasia

Uterine Cervical Diseases

Uterine Diseases

Cervical Intraepithelial Neoplasia

Antirheumatic Agents

Anti-Infective Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Vaccines

Aldesleukin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR Cells at escalating doses, followed by aldesleukin

1 x 10 e11 E7 Cells that was determined in Phase I + aldesleukin

T cells genetically engineered with a TCR targeting HPV-16 E7 (E7 TCR) that display specific reactivity against HLA-A2+, HPV-16+ target cells

E7 TCR cells

Following cell infusion the patient receives high-dose bolus aldesleukin, which is dosed to individual patient tolerance. Aldesleukin improves the survival of E7 TCR cells after infusion.

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Laura A Parsons-Wandell, R.N.

Scott M Norberg, D.O.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers caused by HPV have a HPV protein called E7 inside of their cells. In this new therapy, researchers take a person s blood, remove certain white blood cells, and insert genes that make them to target cancer cells that have the E7 protein. The genetically changed cells, called E7 TCR cells, are then given back to the person to fight the cancer. Researchers want to see if this can help people.

Objective:

To determine a safe dose and efficacy of E7 TCR cells and whether these cells can help patients.

Eligibility:

Adults ages 18 and older with an HPV-16-associated cancer, including cervical, vulvar, vaginal, penile, anal, or oropharyngeal.

Design:

Participants will list all their medicines.

Participants will have many screening tests, including imaging procedures, heart and lung tests, and lab tests. They will have a large catheter inserted into a vein.

Participants will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm.

The cells will be changed in the lab.

Participants will stay in the hospital. Over several days, they will get:

Chemotherapy drugs

E7 TCR cells

Shots or injections to stimulate the cells

Participants will be monitored in the hospital up to 12 days. They will get support medicine and have blood and lab tests.

Participants will have a clinic visit about 40 days after cell infusion. They will have a physical exam, blood work, scans, and maybe x-rays.

Participants will have many follow-up visits with the same procedures. At some visits, they may undergo leukapheresis.

Participants will be followed for 15 years.

Background:

* Metastatic or refractory/recurrent human papillomavirus (HPV)-16+ cancers (cervical, vulvar, vaginal, penile, anal, and oropharyngeal cancers) are incurable and poorly palliated by standard therapies.
* HPV-16+ cancers constitutively express the HPV-16 E7 oncoprotein, which is absent from healthy human tissues.
* Administration of T cell receptor (TCR) gene engineered T cells can induce objective tumor responses in certain malignancies including HPV-16+ cancers.
* T cells genetically engineered with a TCR targeting HPV-16 E7 (E7 TCR) display specific reactivity against HLA-A2+, HPV-16+ target cells.

Objectives:

Phase I Primary Objective

- To determine a safe dose for E7 TCR cells plus aldesleukin for the treatment of metastatic HPV-16+ cancers.

Phase II Primary Objective

-To determine safety and efficacy of E7 TCR cells plus aldesleukin for the treatment of metastatic HPV-16+ cancers.

Eligibility:

* Patients greater than or equal to 18 years old with metastatic or refractory/recurrent HPV-16+ cancer.
* Prior first line systemic therapy is required unless the patient declines standard treatment.
* Patients must be HLA-A\*02:01-positive.

Design:

* This is a phase I/II clinical trial that will test the safety and efficacy of E7 TCR cells.
* All patients will receive a non-myeloablative lymphocyte-depleting preparative regimen of cyclophosphamide and fludarabine followed by a single infusion of E7 TCR cells. Cell infusion will be followed by high-dose aldesleukin.
* Re-enrollment will be allowed for a small number of subjects.

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers

.IPD recorded in the medical record will be shared with intramural investigators upon request.

time from start of treatment to disease progression or death

National Cancer Institute (NCI)

Artesunate

Artemisinins

Artemisinin

Artenimol

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Anthelmintics

Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks

Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks

topical ointment, as a non-surgical treatment

Artesunate ointment

Placebo ointment

Mihaela Plesa

Ahmad Bayat, MD

Edward C. Grendys, MD FACOG, FACS

Donna White

Megan Park

Chad Michener, MD

Mariam AlHilli, MD

Steven Waggonner, MD

Robert DeBernardo, MD

Roberto Vargas, MD

Lindsey Beffa, MD

Johanna Kelley, MD

Daniel Margul, MD

Michelle Kuznicki, MD

This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.

Double-blind, placebo-controlled randomized trial

This study is only for biological females

Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)

Number of participants who have complete histologic response following topical artesunate ointment

Number of participants who achieve clearance of HPV genotypes present at screening. These genotypes become undetectable over the study window.

Number of participants with documented partial response following topical artesunate

Number of participants with documented complete response who do not have recurrence of their vulvar HSIL over the study window

Number of participants who report artesunate-related serious adverse events

The Cleveland Clinic

Frantz Viral Therapeutics, LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors	NCT05592626	Advanced Solid ... Genital Neoplas... Urogenital Neop... Lung Neoplasm Neoplasms by Si... Papillomavirus ... Epstein-Barr Vi... Carcinoma Neoplasms Vulvar Neoplasm... Vulvar Diseases Abdominal Neopl...	STAR0602	18 Years -	Marengo Therapeutics, Inc.
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions	NCT06070454	Vaginitis Vulvar Diseases	vaginitis panel	18 Years -	University of Virginia
E7 TCR T Cells for Human Papillomavirus-Associated Cancers	NCT02858310	Papillomavirus ... Cervical Intrae... Carcinoma In Si... Vulvar Neoplasm... Vulvar Diseases	E7 TCR cells Aldesleukin Fludarabine Cyclophosphamid...	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)	NCT06075264	Vulvar Diseases HPV Infection Vulvar HSIL Pre-Cancerous D... HPV Disease VIN, Usual Type VIN 2 of Usual ... VIN 3 of Usual ... Vin II Vin III VIN Grade 2 VIN Grade 3 High Grade Intr...	Artesunate oint... Placebo ointmen...	18 Years -	Frantz Viral Therapeutics, LLC

Spots Global Cancer Trial Database for vulvar diseases