By InvitationPhase 1

A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors

China12 participantsStarted 2024-05-07

Plain-language summary

This is a Phase 1 open-label study to evaluate the safety, tolerability, and pharmacokinetics of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) at dose of 5×10∧9VP、5×10∧10VP、5×10∧11VP in Patients With Malignant Solid Tumors. Subjects will be treated with a single dose of BioTTT001 Injection after the screening period.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age range from 18 to 80 years old (including the threshold), no gender restrictions.
✓. Patients with histologically and/or cytologically confirmed malignant solid tumors, who have experienced at least one-line standard treatment failure or intolerance, or lack standard treatment options. Focus on malignancies in the head and neck, colorectal cancer, skin malignancies, and cervical cancer.
✓. At least one assessable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
✓. Assessed by the investigators to have lesions suitable for intratumoral injection (assessable lesions and intratumoral injection lesions can refer to the same lesion).

Exclusion criteria

✕. Known allergy to the investigational drug or its components.
✕. Previous treatment with other adenovirus drugs.
✕. Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia).
✕. Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia, pigmentation or other tolerable events judged by the investigator ).

What they're measuring

Incidence of adverse events

Timeframe: 28 days within BioTTT001 injection

MTD

Timeframe: 28 days within BioTTT001 injection

Trial details

NCT IDNCT06215846

SponsorBeijing Bio-Targeting Therapeutics Technology Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-30

View on ClinicalTrials.gov More Solid Tumor trials