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Evaluation of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumor (Phase 1)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanolattix Biotechnology Co., Ltd.

About this trial

This is a first-in-human, non-randomized, open-label, multi-center, phase I study in patients with advanced solid tumor to evaluate the safety and tolerability, PK, immunogenicity, and preliminary anti-tumour activity of T320. This study consists of a dose escalation module and a backfill module. The trial process for each subject in both escalation and backfill module includes a screening period (28 days before the first T320 administration), a treatment period (from the first T320 administration to the end of reatment), a safety follow-up period (28 days after EOT/early withdrawal) and a progression follow-up period (every 12 weeks from safety follow-up visit). Patients will receive T320 administration once every 2 weeks (Q2W) and 28 days are set as one treatment cycle.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary to participate in the clinical study, sign a written informed consent form, and able to comply with clinical visits and study-related procedures.

Age ≥18 years old upon signing the informed consent form.

Have histologically and/or cytologically confirmed unresectable advanced solid tumour who are refractory to or intolerant of available standard-of-care therapy or have no effective standard treatment available.

ECOG performance score of 0 ~ 2.

Disqualifiers

Any anti-cancer therapy including chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment.

Known past or current coagulation defects leading to an increased risk of bleeding or any known bleeding diathesis.

History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.

Known to be allergic to T320 for injection or any of its excipients, or patients with allergic constitution.

Trial design

Design model

Single group

Treatments tested in this trial

  • T320 for Injection

    Biological/Vaccine

    T320 for Injection

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: T320 for InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Time frame
Q2W: Up to 28 days
2

Adverse event (AE) assessed by CTCAE v5.0

Time frame
The period of AE collection starts after the subject receives the T320, until 28+7 days after the EOT/early withdrawal or before the patient starts another anti-tumour treatment (whichever occurs first).
3

Serious adverse events (SAEs)

Time frame
From the signing of the informed consent to 28±7 days after the EOT/early withdrawal or before the patient starts another anti-tumour treatment (whichever occurs first), through study completion, an average of 1 year.
4

maximum tolerated dose (MTD)

Time frame
Q2W: Up to 28 days

Secondary outcomes

1

Best overall response (BOR)

Time frame
through study completion, an average of 1 year
2

Overall response rate (ORR)

Time frame
through study completion, an average of 1 year
3

Disease control rate (DCR)

Time frame
through study completion, an average of 1 year
4

Progression-free survival (PFS)

Time frame
through study completion, an average of 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanolattix Biotechnology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: