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Locally Advanced or Metastatic CancersPhase 1NCT04958434

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

A Phase 1 study testing TST005 in people with Locally Advanced or Metastatic Cancers and Metastatic Human Papillomavirus-Related Malignant Neoplasm, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TST005
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
3 sitesUnited States
Study dates
11 Jun 2021to 30 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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.
  • Severe cardiovascular disease, including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina, New York Heart Association class III or IV heart failure or uncontrolled arrhythmia within 6 months of first dose.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 2 weeks of screening.
  • Clinically significant bleeding within three months of the first dose.
  • Uncontrolled hypertension, defined as systolic ≥150 mm Hg or diastolic ≥90 mm Hg maintained over time and despite antihypertensive treatment.
  • Patients with QTcF > 480 ms on screening ECG or with a history of additional risk factors for TdP (e.g., heart failure, hypokalemia，family history of Long QT Syndrome)
  • Pregnant or nursing.
  • Known human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
  • A serious nonmalignant disease (e.g., psychiatric, substance abuse, uncontrolled intercurrent illness, etc.) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
  • Any other condition that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
  • Active autoimmune disease requiring systemic therapy in the last 2 years prior to the first dose (i.e., with use of disease modifying agents, systemic corticosteroids or immunosuppressive drug).
  • Subjects with Type 1 diabetes mellitus (TD1M), hypothyroidism requiring only hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll.
  • A history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • < 4 weeks after any major procedures/surgery; clinically significant unhealed wound; any unhealed ulceration in GI prior to first dose of TST005.
  • History of severe immune-related adverse effects from checkpoint inhibitor (CPI) therapy (NCI CTCAE Grade 3 or 4) with the exception of endocrinopathy managed with replacement therapy or subjects who discontinued CPI therapy for CPI-associated toxicity or intolerability.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • NEXT Oncology

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: 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

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

Read the 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.

Being tested
TST005
Keywords
PD-L1, TGF-B
Medical subject headings
Neoplasms, Camurati-Engelmann Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TST005Drug

    TST005 is a bifunctional human immunoglobulin G1 (IgG1) monoclonal

Study groups in NCT04958434
Study groupRoleWhat they receive
Part A - Dose EscalationExperimentalDosed every 3 weeks IV with TST005, starting dose is 1 mg/kg, and 5 dose levels will be tested.
Receives: Drug: TST005
Part B - Dose ExpansionExperimentalParticipants with any kind of advanced or HPV metastatic solid tumors dosed Q3W with the Part A Q3W recommended dose of TST005
Receives: Drug: TST005

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 90 days following last dose

  2. 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.

    Measured: Up to 90 days following last dose

Secondary outcomes (11)

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

    Observe changes in AUC over time

    Measured: Up to 90 days following last dose

  2. Part A - Peak Plasma concentration (Cmax) for TST005

    Observe the maximum serum concentration

    Measured: Up to 90 days following last dose

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

    Tmax is the time in hours / days for TST005 to reach the maximum concentration after administration

    Measured: Up to 90 days following last dose

  4. Part A - Terminal half-life of TST005

    Time for serum level to decrease by 1/2 during the terminal elimination phase

    Measured: Up to 90 days following last dose

  5. Immunogenicity of TST005

    To determine if the formation of Anti-drug antibodies (ADA) or neutralizing antibodies (NAb) against TST005 are observed

    Measured: Up to 90 days following last dose

  6. Part B - Assess the Objective response rate (ORR) of TST005

    as measured by RECIST v 1.1 and iRECIST

    Measured: Up to 90 days following last dose

  7. Part B - Assess the Disease Control rate (DCR) of TST005

    Percentage of patients that exhibit stable disease (SD), + partial response (PR), + complete response (CR)

    Measured: Up to 90 days following last dose

  8. Part B - Assess the Duration of Response of TST005

    Measured by the time a patient shows response

    Measured: Up to 90 days following last dose

  9. Part B - Assess the Time to Response (TTR) of TST005

    Measured by the average time patients show a response to TST005

    Measured: Up to 90 days following last dose

  10. Part B - Assess the Progression -free Survival (PFS) of TST005

    Measured by the average time before patients show signs of disease progression after receiving TST005

    Measured: Up to 90 days following last dose

  11. Part B - Assess the Overall Survival (OS) of TST005

    Time between treatment of TST005 and death for any reason

    Measured: Up to 90 days following last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2021
  2. Study start11 Jun 2021
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Why it stopped: Corporate Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Part A - Q3w 3+3 design dose escalation Part B - Dose expansion of approximately 30 patients
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04958434
Sponsor's protocol ID
TST005-1001
Status last verified
Aug 2023
First submitted
17 Jun 2021
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: individual participant data (IPD) will not be shared to other researchers

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TST005 in people with Locally Advanced or Metastatic Cancers and Metastatic Human Papillomavirus-Related Malignant Neoplasm, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Corporate Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A - Determine the maximum tolerated dose (MTD) or recommended Phase 2 dose(s) (RP2D) (time frame: Up to 90 days following last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04958434.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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