History of Changes for Study: NCT04485013

TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	July 21, 2020	None (earliest Version on record)
2	July 29, 2020	Study Status and Contacts/Locations
3	July 29, 2020	Study Status
4	May 4, 2021	Study Status, Contacts/Locations and Study Design
5	June 30, 2021	Study Status and Contacts/Locations
6	October 11, 2021	Outcome Measures, Arms and Interventions, Study Status, Study Design, Study Description, Eligibility, Conditions and Study Identification
7	December 2, 2021	Study Description, Study Status and Contacts/Locations
8	January 7, 2022	Contacts/Locations and Study Status
9	February 3, 2022	Study Status and Contacts/Locations
10	March 5, 2022	Contacts/Locations and Study Status
11	March 31, 2022	Contacts/Locations and Study Status
12	May 2, 2022	Contacts/Locations and Study Status
13	May 20, 2022	Arms and Interventions and Study Status
14	July 11, 2022	Study Status and Contacts/Locations
15	August 3, 2022	Study Status and Contacts/Locations
16	September 6, 2022	Study Status and Contacts/Locations
17	October 7, 2022	Study Status and Contacts/Locations
18	October 12, 2022	Contacts/Locations and Study Status
19	November 30, 2022	Arms and Interventions, Study Status, Study Description, Eligibility, Outcome Measures, Study Design and Conditions
20	December 2, 2022	Contacts/Locations and Study Status
21	January 26, 2023	Study Status and Conditions
22	February 3, 2023	Study Status and Contacts/Locations
23	June 7, 2023	Contacts/Locations and Study Status
24	July 10, 2023	Recruitment Status, Study Status and Contacts/Locations
25	January 5, 2024	Study Description and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	TTX-080-001
Brief Title:	TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
Official Title:	A First-in-human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects With Advanced Solid Tumors
Secondary IDs:

Study Status


Record Verification:	May 2021
Overall Status:	Recruiting
Study Start:	July 14, 2020
Primary Completion:	August 30, 2021 [Anticipated]
Study Completion:	February 1, 2022 [Anticipated]

First Submitted:	July 15, 2020
First Submitted that Met QC Criteria:	July 21, 2020
First Posted:	July 24, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	May 4, 2021
Last Update Posted:	May 7, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	Tizona Therapeutics, Inc
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

This is a Phase 1, multicenter, open-label, multiple-dose, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, and pharmacodynamics of TTX-080 monotherapy in subjects with advanced or metastatic solid tumors known to express HLA-G.

This first-in-human (FIH) study has been designed to evaluate the safety, tolerability, and preliminary antitumor activity of TTX-080 as monotherapy in adults with unresectable or metastatic solid tumors known to express HLA-G.

Detailed Description:

Conditions


Conditions:	Solid Tumor, Adult
Keywords:	HLA-G TTX-080 Advanced Solid Tumor Cancer Ovarian Cancer Endometrial Cancer Cervical Cancer Kidney Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Lung Cancer Prostate Cancer Colorectal Cancer Gastric Cancer Breast Cancer Bladder Cancer Lung Adenocarcinoma Melanoma Metastatic Solid Tumor

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	40 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Monotherapy Dose Escalation	Drug: TTX-080 Variable dose (Q3W)

Outcome Measures


Primary Outcome Measures:
1.	Recommended Phase 2 Dose (RP2D) [ Time Frame: 1 cycle (each cycle is 21 days) ] To assess safety and tolerability of increasing dose levels of TTX-080 in successive cohorts of subjects with advanced solid tumors to identify the maximum tolerated dose (MTD) or maximum administered dose and select the recommended Phase 2 dose (RP2D)/schedule
Secondary Outcome Measures:
1.	Pharmacokinetics (PK) [ Time Frame: Through study completion, an average of 1 year ] Serum concentrations of TTX-080 will be tabulated
2.	Immunogenicity [ Time Frame: Through study completion, an average of 1 year ] Serum levels of antidrug antibody (ADA) against TTX-080
3.	Objective tumor response [ Time Frame: Through study completion, an average of 1 year ] Measure the proportion of subjects with ORR, DoR, and PFS

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Abbreviated Inclusion Criteria: Subject with histological or cytological diagnosis of advanced/metastatic cancer Age 18 years or older, is willing and able to provide informed consent Evidence of measurable disease Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Abbreviated Exclusion Criteria: History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy History of severe autoimmune disease Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

Contacts/Locations


Central Contact Person:	Tizona Therapeutics, Inc. Telephone: 888-585-2990 Email: clinicaltrials@tizonatx.com
Locations:	United States, Connecticut
	Yale Cancer Center [Recruiting] New Haven, Connecticut, United States, 06511 Contact:Contact: Ingrid Palma 203-737-5342 Ingrid.palma@yale.edu
	United States, Florida
	Ocala Oncology Center [Recruiting] Ocala, Florida, United States, 34474 Contact:Contact: Sanjit Nirmalanandhan 352-547-1958 Sanjit.Nirmalanandhan@usoncology.com
	United States, Kentucky
	Norton Cancer Institute [Recruiting] Louisville, Kentucky, United States, 40241 Contact:Contact: Kalyn Weaver Kalyn.Weaver@nortonhealthcare.org
	United States, Nebraska
	Nebraska Cancer Center Oncology Hematology West P.C. [Recruiting] Omaha, Nebraska, United States, 68130 Contact:Contact: Megan Meays, M.A. CCRC 402-691-6971 mmeays@nebraskacancer.com
	United States, New Jersey
	Rutgers Cancer Institute of New Jersey [Recruiting] New Brunswick, New Jersey, United States, 08903 Contact:Contact: Elayne Wesolowsky 732-235-3253 wesoloel@cinj.rutgers.edu
	United States, Pennsylvania
	University of Pittsburgh Medical Center [Recruiting] Pittsburgh, Pennsylvania, United States, 15232 Contact:Contact: Amy Rose 412-647-8587 kennaj@upmc.edu
	United States, Tennessee
	Sarah Cannon Research Institute [Recruiting] Nashville, Tennessee, United States, 37203 Contact:Contact: Kate Dickinson 615-524-4203 kate.dickinson@sarahcannon.com
	United States, Texas
	The University of Texas MD Anderson Cancer Center [Recruiting] Houston, Texas, United States, 77030 Contact:Contact: Lacey McQuinn lmcquinn@mdanderson.org
	NEXT Oncology [Recruiting] San Antonio, Texas, United States, 78229 Contact:Contact: Sarah Gomez 210-580-9521 sgomez@nextsat.com

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: