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

NCT07434609 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: T320-001US
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Advanced Solid Tumor (Phase 1)

Outcome Measures

Primary Outcomes (7)

• Dose-limiting toxicity (DLT)

  Q2W: Up to 28 days

• Adverse event (AE) assessed by CTCAE v5.0

  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).

• Serious adverse events (SAEs)

  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.

• maximum tolerated dose (MTD)

  Q2W: Up to 28 days

• recommended Phase 2 dose (RP2D)

  RP2D as administered once every 2 weeks (Q2W) and 28 days are set as one treatment cycle.

  The RP2D will be finally selected by pooling and evaluating all available efficacy, PK, safety and tolerability data in dose escalation and backfill module, through study completion, an average of 1 year.

• heart rate

  through study completion, an average of 1 year

• electrocardiogram (ECG) QT Interval

  through study completion, an average of 1 year

Secondary Outcomes (17)

• Best overall response (BOR)

  through study completion, an average of 1 year

• Overall response rate (ORR)

  through study completion, an average of 1 year

• Disease control rate (DCR)

  through study completion, an average of 1 year

• Progression-free survival (PFS)

  through study completion, an average of 1 year

• Maximum observed serum concentration (Cmax)

  through study completion, an average of 1 year

Study Arms (1)

T320 for Injection

EXPERIMENTAL

Biological: T320 for Injection

Interventions

T320 for Injection BIOLOGICAL

T320 for Injection

T320 for Injection

Eligibility Criteria

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

You may qualify if:

• 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.
• Escalation module: preferred tumour types include cervix, ovary, endometrium, pancreatic, bladder, prostate, esophageal cancer, HNSCC, triple-negative breast cancer (TNBC), cholangiocarcinoma, and NSCLC. Backfill module: patients with cervix cancer, pancreatic cancer, HNSCC, NSCLC, ovarian and endometrial cancer.
• ECOG performance score of 0 \~ 2.
• Life expectancy ≥ 3 months.
• At least one measurable lesion per RECIST v1.1.
• Adequate organ function defined as following: a) Hematological status: neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 90×109/L, and hemoglobin (HGB) \> 9.0 g/dL (no blood transfusion or hematopoietic stimulating factor therapy within 14 days before the evaluation). b) Coagulation function: international normalized ratio (INR) ≤1.2 (without anticoagulant therapy) and activated partial prothrombin time (APTT) ≤1.25×ULN. c) Liver function: total bilirubin (TBIL) ≤ 1.5×ULN or ≤ 3×ULN in case of Gilbert's syndrome; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5×ULN, if there is liver metastasis, ALT and AST ≤ 5×ULN. d) Renal function: creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min. e) Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; QTcF≤470 ms by Fridericia formula.
• Eligible patients with fertility (male and female) must agree to use reliable contraceptive methods with their partners during the trial period and at least 3 months after the last IP administration; female patients of childbearing age must have a negative serum pregnancy test within 7 days before the first investigational drug administration.
• Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.

You may not qualify if:

• 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.
• Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
• Known history of non-infectious pneumonitis (NIP)/interstitial lung disease (ILD) requiring systemic steroids, active NIP/ILD, or other severe lung disease.
• Presence of grade ≥ 2 peripheral neuropathy.
• Ongoing acute or chronic inflammatory skin disease.
• Presence of ocular surface disease (i.e., confluent superficial keratitis, cornea epithelial defect, corneal ulcer, stromal opacity, etc) or history of conjunctivitis.
• Presence of acute bacterial, viral or fungal infections.
• Untreated, unstable or uncontrolled central nervous system (CNS) metastases, except for: a) No evidence of cerebral edema and no systemic steroids or anticonvulsants requirement at screening and follow-up MRI scan performed within 28 days prior to the first dose of the IMP showing no progression of treated lesion(s) and no new lesion(s) appearing. b) Untreated asymptomatic brain metastasis and no need of local/systematic therapy currently.
• Any prior therapy with a conjugated or unconjugated auristatin derivative.
• Patient requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A4 (Table 3) within 2 weeks prior to the first dose and during the study treatment.
• Have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation, or plan to receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation during the study period.
• History of or currently central nervous system (CNS) lymphoma or other central nervous system diseases.

Sponsors & Collaborators

• Nanolattix Biotechnology Co., Ltd.: lead

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

hua hua hao

CONTACT

15034114930; 1042918290@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 25, 2026
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share