Loading clinical trials...

Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1, First in Human, Open-label, Dose Escalation and Dose Expansion Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors

NCT04958434•Suzhou Transcenta Therapeutics Co., Ltd.

View on ClinicalTrials.gov

Summary

This is an open label Phase 1, first-in-human (FIH) study of TST005, a bi-specific antibody consisting of a PD-L1 monoclonal antibody (mAb) and a transforming growth factor beta (TGF-β) trap in subjects with locally advanced or metastatic cancers

Detailed Description

The study has 2 parts. Part A is a dose escalation portion where the patients will be doses every three weeks following an accelerated 3+3 design. This portion will enroll approximately 25 patients with locally advanced or metastatic cancers. Part B is an expansion portion where approximately 30 additional patients will be dosed at the recommended dose level every 3 weeks. This part will include patients with locally advanced or metastatic HPV related malignancies. The trial will last approximately 2 years, with assessments including safety labs, ECGs, PKs and PDs and CT/MRI tumor assessments, based on the Q3W dosing schedule.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing and able to provide signed and dated informed consent
•2. Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, evaluable by RECIST v1.1. (Part B includes metastatic HPV+ malignancies)
•3. Subject who has tumor progression during or after prior therapy and for whom no standard therapy exists that would confer clinical benefit.
•4. At least one measurable lesion per RECIST 1.1 (Part B only).
•5. Eastern Cooperative Oncology Group Performance Status (ECOG PS)0\~1.
•6. Provide archived tumor tissue samples
•7. Adequate organ function

Exclusion Criteria

•1. Concurrent malignancy within 3 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer not requiring treatment (with or without resection), ductal carcinoma in situ of the breast, or ≤ T1 urothelial carcinoma.
•2. Untreated or symptomatic central nervous system (CNS) metastases.
•3. Any unresolved Grade 2 or greater toxicity from previous anticancer therapy except alopecia.
•4. Active leptomeningeal disease.
•5. Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions:
•* Controlled type 1 diabetes
•* Hypothyroidism (provided it is managed with hormone-replacement therapy only)
•* Controlled celiac disease
•* Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
•* Any other disease that is not expected to recur in the absence of external triggering factors
+19 more criteria

Locations (3)

Gabrail Cancer Center

Canton, Ohio, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Key Dates

Start Date

June 11, 2021

Primary Completion Date

September 30, 2023

Completion Date

September 30, 2023

Last Updated

October 23, 2023

Enrollment

ACTUAL participants

Conditions

Locally Advanced or Metastatic CancersMetastatic Human Papillomavirus-Related Malignant Neoplasm

Interventions

TST005

DRUG