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

NCT04958434 | Terminated Phase 1 FDA Drug

• 1 other identifier: TST005-1001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Locally Advanced or Metastatic Cancers; Metastatic Human Papillomavirus-Related Malignant Neoplasm

Keywords

PD-L1, TGF-B

Outcome Measures

Primary Outcomes (2)

• Part A - Determine the maximum tolerated dose (MTD) or recommended Phase 2 dose(s) (RP2D)

  As measured by the number of participants experiencing a dose limiting toxicity (DLT) in each dosing cohort

  Up to 90 days following last dose

• Part B - Patient safety as characterized by frequency and severity of adverse events

  Characterize the safety profile of TST005 including the frequency and severity of treatment-emergent adverse events.

  Up to 90 days following last dose

Secondary Outcomes (11)

• Part A - Area under Plasma concentration vs. time curve (AUC) for TST005

  Up to 90 days following last dose

• Part A - Peak Plasma concentration (Cmax) for TST005

  Up to 90 days following last dose

• Part A - Time to maximum observed serum (Tmax) for TST005

  Up to 90 days following last dose

• Part A - Terminal half-life of TST005

  Up to 90 days following last dose

• Immunogenicity of TST005

  Up to 90 days following last dose

Study Arms (2)

Part A - Dose Escalation

EXPERIMENTAL

Dosed every 3 weeks IV with TST005, starting dose is 1 mg/kg, and 5 dose levels will be tested.

Drug: TST005

Part B - Dose Expansion

EXPERIMENTAL

Participants with any kind of advanced or HPV metastatic solid tumors dosed Q3W with the Part A Q3W recommended dose of TST005

Drug: TST005

Interventions

TST005 DRUG

TST005 is a bifunctional human immunoglobulin G1 (IgG1) monoclonal

Part A - Dose Escalation; Part B - Dose Expansion

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• Untreated or symptomatic central nervous system (CNS) metastases.
• Any unresolved Grade 2 or greater toxicity from previous anticancer therapy except alopecia.
• Active leptomeningeal disease.
• 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
• Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of investigational product, with the following exceptions:
• Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
• Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
• Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
• History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases, including but not limited to pulmonary fibrosis, active pneumonitis.

Sponsors & Collaborators

• Suzhou Transcenta Therapeutics Co., Ltd.: lead

Study Sites (3)

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms; Camurati-Engelmann Syndrome

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Charlie Qi, MD

  Suzhou Transcenta Therapeutics Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A - Q3w 3+3 design dose escalation Part B - Dose expansion of approximately 30 patients

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 12, 2021
• Study Start: June 11, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)